Questions for Discussion
“An Essential Partnership”
Principles & Guidelines for Working with
This document has been developed as a result of recommendations from the AMRC Industry Working
Group (IWG), which met during 2006. It draws on the views, opinions and experiences of members, the
results of our survey on medical research charities working with industry, carried out at the end of 2006,
and the ongoing dialogue we have had with industry representatives. However, feedback from the IWG
on initial drafts of this document highlighted concerns that the wider membership had not been afforded
the chance to provide their input into its development.
AMRC believes that the Principles and Guidelines reflect current good practice and are comprehensive
in detailing how charities should approach collaboration. Its launch is an opportunity to open them up to
wider scrutiny and discussion within our membership, but also among other interested parties, and we
very much welcome thoughts, ideas and comments in response.
The following questions are intended to encourage this debate:
1) The document describes collaboration between charities and industry as “An Essential
Partnership”: Do the Principles and Guidelines strike the right tone and style in emphasising the
importance of collaboration between medical research charities and industry?
2) Are the guiding principles – Independence, Openness, Integrity – suggested by AMRC the
right ones for the medical research charity sector?
3) The document seeks to describe the many different partnerships which charities can form
with industry, under the broad headings of ‘Development’, ‘Research’, ‘General Principles of
Partnerships’, ‘Sponsorship’ and ‘Policy & Campaigning’. Is the guidance comprehensive in this
respect? Have any important aspects of charity/industry partnerships been left out?
4) What is your opinion of the appended guidance on the handling of intellectual property? Is it
comprehensive, and does it take the right line on this complex issue?
5) AMRC intends this document to be used by members and to inform their future work with
industry partners. To facilitate its use, it will be provided in a web-based format, with links in the
contents page for ease of navigation. Bearing this in mind, does the document strike the right
balance between comprehensiveness, and offering guidance which is concise, clear and easy to
6) Do you have case studies of good practice that would help to illustrate some of the points
made in the document?
7) What further work should AMRC be seeking to do in this area?
Please send your comments to email@example.com by 1 Sept 2007. We anticipate issuing our
Principles and Guidelines in their final form this autumn.
“An Essential Partnership” Page 2 of 48
AMRC Principles for Working with Industry
AMRC believes that collaboration between medical research charities and industry is essential to
increase scientific knowledge and understanding, and also to the development of new treatments and
interventions for patient benefit.
The development of partnerships across public funders and with industry is essential to bring new
treatments, ideas and innovations into health care settings. Furthermore, the Government, through the
UK Clinical Research Collaboration (UKCRC), and the recent review of health research funding (the
Cooksey Review), has emphasised the need for all parts of the research community to work together in
providing beneficial outcomes to the public, patients and to the economy. Medical research charities,
as a significant source of funding but also as patient organisations, will play an increasingly important
role in this relationship.
In contrast to the current scenario, where the relationships between charities and industry are
orientated towards public information, education and awareness, AMRC believes that upstream
collaborations will increase in the future. We see this direction as a positive move, with the potential to
engage and enable patient and public concerns to be taken into account earlier in the research
process, thereby working towards better outcomes for all parties.
Nevertheless, it is likely that most collaborations will form around the latter agenda and that industry will
continue to represent an important source of funds for many charities. However, it should be noted
that, for a variety of reasons, some medical research charities will choose not to work with industry and
this decision will always be respected.
In all interactions with industry, it is important that charities strive to abide by the following general
The remainder of these guidelines are intended to provide member charities with advice, support and
access to additional sources of information that will be helpful to them in building collaborations in line
with their charitable objectives.
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Table of Contents
AMRC Principles for Working with Industry 3
An Essential Partnership 5
Summary of Recommendations 6
About this Document & its Relation to Existing Guidance 8
The Main Players in the Pharmaceutical & Healthcare Industries 9
Association of British Pharmaceutical Industries 9
Association of British Healthcare Industries 9
BioIndustry Association 9
British In Vitro Diagnostic Association 9
The Regulatory Framework for Medicines, Medical Devices & Healthcare
Medicines & Healthcare Products Regulatory Authority 10
European Agency for the Evaluation of Medicinal Products 11
National Institute for Health & Clinical Research 11
Summary of Legislation 12
AMRC Recommendations 13
Forms of Collaboration 13
Matters for Consideration 15
AMRC Recommendations 17
Research Partnerships 18
Using Products from Industry for Research 21
General Principles of Partnership 23
AMRC Recommendations 23
Guidance from the Charity Commission 24
AMRC Recommendations 25
Issues around Sponsorship 26
Charity Endorsement of Products 26
Policy & Campaigning 28
AMRC Recommendations 28
Examples of Collaboration on Issues of Policy or Lobbying 28
“An Essential Partnership” Page 4 of 48
An essential partnership
AMRC believes that collaboration between medical research charities and industry is essential to
increase scientific knowledge and understanding, and also to the development of new treatments and
interventions for patient benefit. Charities work in a complex environment and have interactions with
many sectors in order to achieve their objectives; the role played by the pharmaceutical and other
industries in bringing drugs and devices to market is not something that most charities can do, yet it is
often what patients want. The UK Government has signalled the importance of joint working
relationships through its acceptance of the recent Cooksey Review1 and support for the UK Clinical
Research Collaboration (UKCRC). A primary part of UKCRC’s mission is to improve the environment
for conducting clinical research which has positive benefits for both commercial and non-commercial
research. Both the recommendations arising from the Cooksey review and the MRC’s own strategic
declaration have also emphasised the importance of a more holistic approach to health research;
working in close collaboration across public, private and voluntary sectors.
In 2006, AMRC set up an industry working group (see Appendix 1 for remit and membership) to
consider the manner in which charities could build such collaborations and the issues that might be
raised. The group concluded that a set of principles and guidelines, covering the range of interactions
that charities may have with industry would be timely and useful. However, it was recognised that very
little was known about the range or extent of members’ involvement with industry and a survey was
therefore conducted in 2006 to provide some background data about the most frequent interactions
(see Appendix 2). Although a number of other organisations have guidelines or policies addressing
these relationships, the unique nature of medical research charities, which can have a wide diversity of
interactions with industry, encouraged AMRC to develop what, it is hoped, is a comprehensive set of
principles and guidelines covering the following areas:
General Principles of Partnership
Policy and Campaigning
Many charities may choose, for a variety of reasons, not to work with industry and AMRC respects this
decision. Publication of these guidelines does not imply that it is a requirement for charities to form
such partnerships, but they are intended to provide information about industry and the regulatory
environment that governs drug development in the UK, outline the range of partnerships that are
possible – illustrated using a selection of case studies – and highlight factors that charities may wish to
consider when setting up partnerships.
In providing an overview of the types of relationship which charities can establish with the healthcare
industries, it is our intention that this guidance should be an aid to our members in the formation of
successful, productive collaborations with industry. In addition, guidance for charities that work or may
wish to work with the pharmaceutical and healthcare industries has become essential in light of the
media focus upon cases which appear to expose an unhealthy influence by industry upon patient
groups and the charity sector. Feedback from AMRC member charities has emphasised the
importance they place upon their independence and integrity and we believe that these guidelines will
help members to identify issues that they should be aware of and help them to be clear regarding their
position when establishing partnerships.
“An Essential Partnership” Page 5 of 48
Summary of Recommendations
Recommendations from the document are summarised below. Many of these pertain to particular
situations, although there are general principles that will apply across all collaborations and
partnerships. Charities should keep the three principles of independence, integrity and openness at the
core of their strategy when developing relationships with industry partners.
Where a charity seeks to involve its members in a collaboration with industry, it should be in
pursuit of the charity’s mission, with public good, patient benefit and welfare as the primary
Any such collaboration must clearly support the charity’s own agenda and strategy;
potential collaborations should be assessed by rigorous peer review, as with any other
project with which the charity engages or contributes funding.
A collaborative project involving patients must have a clearly defined remit and parameters.
It should be governed by pre-defined conditions and protocol.
The charity should monitor the progress of the scheme and, as far as it is able, seek to
ensure that the industrial partner complies with the pre-conditions set out by the charity and,
for pharmaceutical companies, with the regulations contained within the ABPI Code of
Practice. In particular, the pharmaceutical companies must not use the partnership to
directly or indirectly advertise its products to patients.
When funding any research, charities should ensure that their terms and conditions of
award cover their expectations regarding intellectual property. AMRC has produced a set of
standard guidelines which members may use.
Charities may wish to satisfy themselves that host institutions and their staff have codes of
practice or staff guidelines governing their relationships with industry.
When deciding upon whether to award a grant to a particular institution or department,
charities may also wish to consider which other organisations also fund there and whether
there are likely to be any conflicts of interest or reputational risks to the charity.
Charities should ensure that if they are consulting industry staff regarding any aspects of
research, discussions need to be covered by confidentiality agreements. The position and
affiliations of all advisors to the charity, whether or not linked with the healthcare industries,
should be clarified and underpinned by a robust conflicts of interests policy.
Direct collaboration with industry or direct funding by a charity of a project that is carried out
by industry should be subject to a clear agreement and terms and conditions outlining each
partner’s expectations, particularly around intellectual property and publications.
Charities should be aware of Charity Commission guidelines ‘Fundraising through
Partnerships with Companies’.
Charities should discuss their principles for partnerships internally and with trustees and
other stakeholders before developing written guidelines.
In order to maintain independence and integrity, charities should develop their own written
Charities should be open and transparent about the partnerships that they form.
Subject to staff turnover and other factors, charities should seek to ensure that they have an
established point of contact within the relevant company.
Written agreements should be drawn up at the beginning of a partnership; charities should
ensure that there is a mechanism for monitoring and evaluating the outcomes of the
Charities seeking financial contributions from industry should have a thorough
understanding of the company, prior to seeking support.
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If a company does offer financial support, the charity should be clear about the company’s
expectations and whether these are in line with the charity’s own charitable objectives.
Pharmaceutical companies are required to indicate their sponsorship of an activity or
publication and charities must enable this but should also ensure that it is proportionate.
Use of a charity’s logo or any of its materials by the industry partner must have prior written
agreement from the charity.
Charities must be prepared to state where they have received industry support on all
publicity and other materials associated with a particular programme.
Charities should report their collaborations and the financial contributions received from
industry in their annual reports and accounts.
Charities should, where possible seek to work with a number of industry partners when
producing educational material or with the relevant trade body.
Charities should ensure at the outset that they retain editorial control over the content of any
publications or materials which will bear their name, but must exercise caution that they do
not endorse individual treatments.
Policy and campaigning
Where a charity becomes involved with a collaborative lobbying campaign, the charity
should ensure that the activity is in line with its charitable and strategic objectives.
The terms of any such collaboration should be governed by a written agreement between
the two parties.
When working with third parties which may be funded by or otherwise linked to industry,
charities should seek to ensure that, wherever possible, they are aware of any such links
and that both parties are open and transparent about their existence.
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About this Document & its Relation to Existing
In compiling this document, AMRC was aware of – and indeed drew on – a considerable amount of
existing guidance, policy and recommendations around collaboration between charities and the
healthcare industries. Much of this existing guidance is referred to elsewhere in the document but for
ease of reference it is summarised in this section.
The Long-Term Medical Conditions Alliance (LMCA) produced guidelines on working with the
pharmaceutical industry in 2003. Currently, these are available online only to LMCA members,
however, AMRC members may be able to request a copy by contacting the LMCA directly
(www.lmca.org.uk). The LMCA is currently seeking funding for a project to update their 2003 guidance.
The Health Coalition Initiative
The Health Coalition Initiative has produced guidance for VHOs and the pharmaceutical industry:
(http://www.healthcoalitioninitiative.org.uk/files/hci_booklet.pdf) which also contains a draft model
agreement that members may find helpful. A useful general web site on partnerships is available at:
The ABPI Code of Practice 2006
In response to the House of Commons Select Committee report on the Influence of the Pharmaceutical
Industry, The Association of British Pharmaceutical Industries (ABPI) has produced a revised code of
practice for its members which covers relationships between pharmaceutical companies and charities.
Many member charities, as discussed subsequently in this document, have also produced their own
policies on activities in relation to industry. Similarly, a number of pharmaceuticals have developed
policies around their interactions with charities. Links to some of these policies are provided in
Appendices 4a and 4b.
This document is not intended to supplant existing guidance, yet nor does it merely repeat what many
organisations have already achieved: by providing detailed summaries and case studies of the many
different ways in which charities and industry can work together, AMRC hopes that these guidelines will
provide working examples of how effective collaborations might be achieved, which will be of direct
relevance to our member charities. The AMRC guidelines complement existing guidance in providing a
framework of best practice for dealing with the issues which may arise from such partnerships; yet
within this framework they are also intended to provide a basis to actively encourage the formation of
productive and responsible relationships between charities and industry.
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The Main Players in the Pharmaceutical &
There are a wide variety of industries involved in research, development and delivery of healthcare,
although most people identify the pharmaceutical industry as the main player. From our survey of
members’ interactions it is clear that although major pharmaceutical companies comprise the industry
group that charities interact with most frequently, there are also links with smaller biosciences firms and
others, such as device manufacturers. Most types of industry have their own trade associations and
here we provide links to their web sites and describe briefly the types of organisations that they
represent. Most of these web sites provide links to their members’ individual web sites.
Association of British Pharmaceutical Industries: www.abpi.org.uk
The Association of British Pharmaceutical Industries (ABPI) is the trade association for over 75
companies that produce prescription medicines. There are a number of categories of membership and
they represent also those organisations with affiliated links.
The ABPI produces information about the extent of investment by the pharmaceutical industry in the
UK, generic literature about a range of medical conditions and provides advice to its members and the
wider public about regulatory issues. It has developed a code of practice which covers the promotion of
prescription medicines to health professionals and administrative staff and also covers information
made available to the general public about prescription only medicines. The Prescription Medicines
Code of Practice Authority (PMCPA) http://www.abpi.org.uk/links/assoc/pmcpa.asp has been set up to
operate the code at arm’s length from the ABPI.
Association of British Healthcare Industries: www.abhi.org.uk
The Association for British Healthcare Industries (ABHI) describes itself as “the lead trade association
for the medical technology industry.” Within this umbrella it represents a diverse sector, comprising
manufacturers of medical devices and technologies, as well as service industries (e.g. lawyers,
architects) working in healthcare. The ABHI currently has over 200 members, whose combined spend
accounts for 80% of the industry’s total output. The Association also seeks to work with patients and
patient groups, aiming to increase uptake of new medical technologies and hence increase patient
access to important medical innovations.
BioIndustry Association: www.bioindustry.org
The BioIndustry Association (BIA) has over 300 members, which are mainly research based
biotechnology companies. The Association represents the industry to a broad range of stakeholders,
including patient groups, politicians and the media.
The BIA achieves this representation by providing an active public affairs programme, events and
regular publications aimed both at members and external stakeholders. It also seeks to raise standards
within the sector through the dissemination of best practice guidance and advises companies on
British In Vitro Diagnostics Association: www.bivda.co.uk
BIVDA is a trade body for companies with a major interest and involvement in the in vitro diagnostic
industry and represents about 100 manufacturers and distributors active in the UK in this area.
“An Essential Partnership” Page 9 of 48
The Regulatory Framework for Medicines,
Medical Devices & Healthcare Products
In order to be licensed for use in the UK, all medicines, medical devices and other healthcare products,
such as blood and tissue-engineering products, must be approved by the appropriate regulatory
authority. UK national approval and licensing is conferred by the Medicines and Healthcare products
Regulatory Authority (MHRA); manufacturers of new medicinal products can also seek EU-wide
approval from the European Medicines Authority (EMEA).
Manufacturers of licensed products must be able to demonstrate clear standards of safety, efficacy and
quality, to the satisfaction of expert advisory groups working within one of these regulatory bodies.
Licensing legislation is broadly based on EU Directive 2001/83/EC, which has been subsequently
amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC.
The licensing procedures of both the MHRA and EMEA are summarised below and the role of NICE is
Medicines and Healthcare products Regulatory Authority (MHRA): www.mhra.gov.uk
The MHRA grants a number of different licenses, all of which must be obtained before a new medicine
can be marketed in the UK.
Each new medicine must first be granted an individual Marketing Authorisation. In addition,
separate manufacturers' and wholesale dealers' licenses must be granted to the parties involved
in the production and distribution of the product. Finally, products which are in development must
be granted a Clinical Trial Authorisation before they can be tested in human subjects.
Applications for a new license can fall under one of three categories:
Application for a new active substance
Application where the active ingredient has been previously evaluated
Applications for biological and biotechnological products.
In all cases, the merits of the application are assessed by a multi-disciplinary team of experts who
judge from the data provided by the applicant whether or not the product meets the requirements
of safety, quality and efficacy as specified by Directive 2001/83/EC. The principle advisory body is
the Committee for the Safety of Medicines (CSM); however, independent expertise can also be
consulted by the assessment team.
In order for a medicine to be granted Marketing Authorisation, its safety and efficacy must first
have been adequately demonstrated in man. The initial stage in licensing a new drug is therefore
to obtain a Clinical Trial Authorisation from the MHRA. These licences are granted on the basis of
supporting data demonstrating the drug’s safety in animal models, although drugs that act via a
novel, potentially species-specific pathway, or which act directly or indirectly on the immune
system, are deemed to be of higher risk and additional advice must first be sought from the
Commission for Human Medicines (CHM). In addition to the MHRA license, approval for a clinical
trial must also be obtained from an ethics committee (see Central Office for Research Ethics
Committees - COREC).
After the initial (Phase I or “first-in man”) clinical trial with healthy volunteers, further (Phase II and
III) trials are undertaken to demonstrate the efficacy of the new product in patients. It is normally at
this stage that patient groups can be of particular value to drug developers in helping them to
recruit sufficient numbers of subjects for their trial.
The MHRA has more detailed information on clinical trials and the process of gaining a Clinical
Trial Authorisation at:
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On gaining Marketing Authorisation, a new medicine is initially licensed for five years. At the end
of this period, the licence can be renewed and, if successful, the product is then licensed
indefinitely, barring new developments (for example data accrued through pharmacovigilance
studies), which might call its licence into question.
Medical devices are not granted licensing approval directly through the MHRA. Instead, their
approval is granted by private sector organisations known as “Notified Bodies”, which are
themselves regulated by the MHRA. The approval of a notified body is required before a new
medical device can have a CE mark attached to it; low-risk devices, however, are simply
registered with the MHRA.
Tissue Engineered Products
Under new regulation proposed by the European Commission on 16 November 2005, the
regulation of tissue engineered products would be centralised, along with the regulation of
products derived from gene or cell-based therapy, under the umbrella of “Advanced Therapy
Medicinal Products”. All such products would have to be submitted to the EMEA for approval;
however, licensing of stem cell and embryo-based therapies would remain under the jurisdiction of
nationally competent authorities (i.e. the MHRA in the UK).
European Agency for the Evaluation of Medicinal Products (EMEA): www.emea.eu.int
New medicines and healthcare devices may also be submitted for approval to the EMEA, which is
competent to grant a marketing authorisation valid throughout the EU.
The structure of the EMEA is based around two overarching bodies; the Committee for Medicinal
Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use
(CVMP). Two further bodies, the COMP and the HMPC, are responsible for designation of orphan drugs
and for regulation of herbal medicines respectively.
The CHMP was established under Regulation (EC) No. 726/2004 and is responsible for assessing all
applications for central licensing of new medicines targeted to humans. As with the MHRA, applications
are peer reviewed by a panel of experts and assessed on their fulfilment of criteria of quality, efficacy
and safety. The peer review teams draw on expertise sourced from the competent regulatory authorities
of 25 EU member states, including the MHRA.
As well as being responsible for EU-wide licensing of medicinal products, the EMEA may also act as an
arbitrator in cases of disagreement between member states over multi-recognition or decentralised
licensing procedures. The CHMP is also responsible for coordinating pharmacovigilance activities in
order to facilitate continued assessment of medicines after licensing. Where such activities highlight
serious concerns over the use of a currently licensed product, the CHMP is authorised to make an
Urgent Safety Restriction (USR), which prohibits further use of the product until such time as these
concerns have been fully addressed.
National Institute for Health and Clinical Excellence (NICE): www.nice.org.uk
The National Institute for Health and Clinical Excellence (NICE) is a UK-based independent organisation
that provides advice on the promotion of good health and the prevention and treatment of ill health.
Unlike the MHRA, NICE has no regulatory function. Instead, it seeks to provide advice on the adoption
and use of new and existing medicines and health technologies within the NHS. Specifically, the areas it
provides guidance on are as follows:
Public health - guidance on the promotion of good health and the prevention of ill health for
those working in the NHS, local authorities and the wider public and voluntary sector
Health technologies - guidance on the use of new and existing medicines, treatments and
procedures within the NHS
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Clinical practice - guidance on the appropriate treatment and care of people with specific
diseases and conditions within the NHS.
Guidance within these three areas is issued by separate centres; the Centre for Public Health
Excellence, the Centre for Health Technology Evaluation and the Centre for Clinical Practice.
Depending on the type of guidance issued, NHS Trusts are expected to adopt NICE recommendations
or take note of its guidance in making decisions:
Clinical guidelines – Review current procedure and take into account resources needed to
Public Health Guidance – Take into account when developing local area agreements
Technology Appraisals – Fund recommended treatments within three months of guidance
Interventional Procedures – Check whether NICE has issued guidance before carrying out a
new intervention; if not, obtain approval from Trust’s clinical governance committee and
ensure patients have given consent
NICE guidance is adopted to differing degrees by the devolved administrations: whereas all four types
of guidance listed above apply in England, NICE public health guidelines do not apply in Wales and
Northern Ireland and neither public health guidance nor clinical guidelines apply in Scotland.
Summary of Legislation
Regulation (EC) No. 2309/93: established EMEA and a centralised authorisation procedure
for human and veterinary medicines.
Regulation (EC) No. 726/2004: replaces Regulation 2309/93
Directive 2001/83/EC: laid down EC codes on medicines for human use. Established
provisions governing their marketing authorisation, manufacture and distribution.
Directive 2004/27/EC: amended Directive 2001/83/EC.
Whereas EC regulations are applicable directly in UK law, Directives must be adopted through
further UK legislation. The provisions of Directive 2001/83/EC were therefore adopted into UK law
by the following Acts of Parliament, which came into force on 30 October 2005:
The Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations
2005 (SI 2005/2753)
The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (SI 2005/2759)
The Medicines (Advertising Amendments) Regulations 2005 (SI 2005/2787)
The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous
Amendments) Regulations 2005 (SI 2005/2789)
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Where a charity seeks to involve its members in a collaboration with industry, it
should be in pursuit of the charity’s mission, with public good, patient benefit and
welfare as the primary aims.
Any such collaboration must clearly support the charity’s own agenda and strategy;
potential collaborations should be assessed by rigorous peer review, as with any
other project with which the charity engages or contributes funding.
A collaborative project involving patients must have a clearly defined remit and
parameters. It should be governed by pre-defined conditions and protocol.
The charity should monitor the progress of the scheme and, as far as it is able, seek
to ensure that the industrial partner complies with the pre-conditions set out by the
charity and, for pharmaceutical companies, with the regulations contained within the
ABPI Code of Practice. In particular, the pharmaceutical companies must not use the
partnership to directly or indirectly advertise its products to patients.
For the pharmaceutical, medical devices and biotechnology industries, medical research charities
provide a valuable link to patients whose experience, opinions and participation can be vital in the
development of new treatments or in improving the performance and marketability of existing products.
From the charity perspective such collaborations can enable it to further its objectives – if current or
future treatments for patients are the desired aim.
Many large pharmaceutical companies are re-examining the model of closed “in house” drug
development, in response to the increasingly high costs of drug development and the consequent
narrowing of profit margins.2 Some companies have begun to recognise that a more decentralised,
‘disaggregated’ approach to development, working in collaboration with smaller biotech and university
partners, might prove to be more cost-effective and enable greater flexibility when choosing which
candidate compounds to develop further. An important aspect of this approach is enabling patient
needs and concerns to be taken into account; indeed Paul Stoffells, Head of Research at Johnson and
Johnson, emphasised that “value for the patient” is key to recovering the costs of drug development.
Charities which provide care and/or education as well as funding medical and health research gain
valuable knowledge about the immediate issues for patients and carers, and most charities have good
links with the medical profession and clinical and academic researchers. In many cases, charities also
enable and encourage patients and carers to input into their research strategy and many involve lay
reviewers on peer review panels. Such links provides the charity with valuable insights into research,
current treatments, the experiences and aspirations of both patients and medical professionals and the
ability to identify where treatment gaps exist. Of course, many patient groups don’t necessarily want
more treatment options and often consider that a charity’s resources are better directed at discovering
causal factors and working to prevent these, while others find that the area in which they work is
neglected by industry. However, in cases when treatment is an important option and given that the
input of patients and charities is likely to become increasingly valuable to industry partners, careful
management of these relationships will be required.
Forms of collaboration
With the wealth of information that charities have about the needs of patients there is often the
expectation that they will be proactive in bringing patient’s concerns to the attention of those best
placed to act upon them. However, a multitude of factors will determine whether this hope is
achievable. Those charities that already have relationships with industry may be able to bring particular
issues to their attention, hold scientific meetings and focus groups with patients and industry
representatives and write reports based on research and patient experience which can be useful
resources. Links and collaborations with medical research charities may also prove beneficial to
The Economist 25th January, 2007.
“An Essential Partnership” Page 13 of 48
industry in helping to recruit subjects for clinical trials. In an ideal scenario, if charities can provide
evidence that helps to develop more effective and tailored treatments for their patients, benefits can
emerge for all parties. However, many charities may seek to do their evidence gathering without the
support or input from industry initially.
Patient input in product development
Charities’ links with patients can, in many cases, allow them to facilitate their input into the
development of novel or improved medical devices or interventions, as the example demonstrates
(Case Study 1).
Case Study 1: Development of improved nebulisers for people with cystic fibrosis
In 2000, the Cystic Fibrosis Trust was approached by PARI, a manufacturer of nebulisers, devices
which deliver antibiotics via inhalation. PARI wanted to consult patients on possible improvements to
the design of nebulisers, in order to make them more user friendly and to increase compliance,
particularly among younger users. The Trust agreed that the company could contact its patient
members, who were very willing to provide their feedback and observations to the company. Their
concerns, such as the lack of portability, which restricted freedom of movement and meant that the
procedure had to be carried out at home, were taken on board by the company. Subsequently, it
altered the design to create a much smaller, portable product which patients found far easier and more
comfortable to use. The success of this strategy has certainly been felt by patients: in a discussion of
different brands of nebulisers on the CF Trust’s website, one patient said of the new product:
“This is by far the best advancement for CF since DNase hit the market” (Source: CF Today – Autumn
Patient involvement in clinical trials
Clinical trials are another area in which patients and patient groups can establish important and
productive working relationships with industry. As discussed previously, any new drug must,
before it is licensed, demonstrate efficacy and safety in a large number of patients. Charity
involvement, both at the trial design stage as well as in patient recruitment can be helpful to the
success of a trial but those conducting clinical trials often have difficulty ensuring that patient’s
concerns are taken into consideration. When the agenda is dictated by industry, charities may
question the value of being involved and the true benefit that would accrue to patients.
In the past, it was often difficult to discover which trials were taking place and charities reported
dissatisfaction amongst patients about follow-up once a trial had ended. Provision of this type of
information has improved, with the establishment of the UK Clinical Trials Register (UKCTR):
http://www.controlled-trials.com/ukctr/ but there is still some way to go, particularly with regard to
reporting trial outcomes. The UK Clinical Research Collaboration (UKCRC) and its role in
improving the environment for carrying out clinical research within the NHS has already been
briefly discussed. Within the UKCRC umbrella, the UK Clinical Research Network (UKCRN) has
been established to facilitate clinical trials within the NHS; bringing together patient groups and
researchers, creating an improved infrastructure and improving and facilitating patient recruitment
into trials. UKCRN has already established a number of topic-specific disease networks and, from
April 2007, the UK Comprehensive Research Network will work towards providing infrastructure
for all disease areas across the UK.
Although facilitating the progression of drugs to market in this way can further a patient group’s
agenda, patients involved at this level should not necessarily be seen as passive subjects of
research. On the contrary, there are many examples of well informed patients actively pushing a
research agenda forward, and charities’ interaction with industry can be one way in which they
are able to achieve this (See Case Study 2).
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Case Study 2: The development of the ‘Cannabis for Multiple Sclerosis (CAMS)’ trial
For many years, people with multiple sclerosis had proclaimed the therapeutic benefits of cannabis,
despite its legal status, but until the late 1990s these claims remained anecdotal. In 1997, GW
Pharmaceuticals Ltd gained a Home Office license to produce the drug for experimental purposes, and
highlighted patient experiences as the motivating factor to test the effect of cannabis in the relief of MS
symptoms in clinical trials. The announcement of these trials prompted a huge level of patient interest,
testimonies, and interest in participating in future trials. Indeed, the wealth and diversity of this active
patient involvement inspired the company to expand the focus of its work to include investigations of
cannabis use for cancer-related pain and spinal cord injury.
These developments, along with the testimonies of its own patient members, prompted the Multiple
Sclerosis Society (MSS) to lobby for further research into the possible therapeutic benefits of
cannabis. A trial protocol, developed jointly by the MSS and the Royal Pharmaceutical Society, was
successful in securing £1.2 million of funding from the MRC.
The trial had mixed results; although the subjective experiences of patients taking the drug, as
assessed by questionnaire, showed a significant improvement in pain, sleep quality, spasms and
spasticity versus the placebo group, cannabis treatment was not found to have had a significant effect
on muscle spasticity. Nonetheless, the trial demonstrates that patients can directly advance their own
Many charities find that there may be little industry interest in the condition they represent and
they will want to find mechanisms by which they can stimulate or encourage that interest. While a
number of initiatives have been successful in focusing attention on treatment development for
diseases that afflict developing or third world countries, it can be difficult to generate the same
incentives in the developed world.
However, programmes to encourage the pharmaceutical industry to invest in this area have been
initiated in the EU (http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm). In some cases,
charities may find it helpful to think outside of the strict definition of the particular condition they
represent and as underlying mechanisms are discovered, they may be able to identify
commonalities with a range of conditions. Such common ground may make it easier for
pharmaceutical companies to decide to invest in a programme of research if it is likely that any
drugs developed will have wider applicability.
Whether or not they maintain a relationship with a pharmaceutical company or have had
involvement in developing a treatment or product, charities should ensure that in promoting any
treatment, they do so only after full consultation with the scientific and medical expertise available
to them. Some sources have in the past argued that the pharmacutical industry encourages
‘medicalisation’ and identifies conditions (and treatments) where none exists.3 Regardless of
whether there is any justification in these claims – and many would argue that promoting public
awareness of disease achieves tangible patient benefits as well as commercial gain – charities
are possesed of the requisite expertise to make informed decisions on any new treatment;
provided such expertise is correctly utilised, the charity will be able to assure patients that it is
acting independently and in their best interests.
Matters for consideration
Collaboration between charities and industry can be a powerful mechanism in the development or
modification of healthcare products and in implementing clinical trials, which can undoubtedly benefit
charities and their stakeholders. As with any collaboration, challenges will undoubtedly arise: some
industry partners might see their relationship with a charity as a way to raise their profile among
potential customers and charities must be aware of the potential issues that may arise from such
interactions and take steps early in the process to ensure that their integrity and independence are not
Moynihan R, Heath I, Henry D. Selling sickness: the pharmaceutical industry and disease mongering. BMJ 2002; 324: 886-890
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While the ABPI Code of Practice for the Pharmaceutical Industry 2006 covers the relationship of
pharmaceutical companies with charities, it should be remembered that it covers the promotion of
prescription medicines and does not apply to other types of industry. However, the Code could be used
to provide a yardstick for charities in their dealings with industries other than pharmaceutical
companies. Clause 20.3 of the Code covers the relationships with patient organisations and requires
that the company must declare any involvement with a patient organisation and they must make public
(on their website or in their annual reports) a list of all patient organisations to which they have made
financial contributions. Where possible, publication of these details should be timely, providing details
of industry relationships whilst they are still current. Companies must also have written agreements in
place covering all aspects of the relationship. Clause 10 of the Code covers ‘disguised promotion’ and
charities should feel assured that any market research activities are being conducted with a scientific or
educational purpose and are not disguised promotion on the part of the company. Charities too should
consider how they would manage the relationship and be prepared to be open about their reasons for
engaging with the industry partner and how they will ensure openness and transparency.
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When funding any research, charities should ensure that their terms and conditions
of award cover their expectations regarding intellectual property. AMRC has
produced a set of standard guidelines which members may use.
Charities may wish to satisfy themselves that host institutions and their staff have
codes of practice or staff guidelines governing their relationships with industry.
When deciding upon whether to award a grant to a particular institution or
department, charities may also wish to consider which other organisations also fund
there and whether there are likely to be any conflicts of interest or reputational risks
to the charity.
Charities should ensure that if they are consulting industry staff regarding any
aspects of research, discussions need to be covered by confidentiality agreements.
The position and affiliations of all advisors to the charity, whether or not linked with
the healthcare industries, should be clarified and underpinned by a robust conflicts
of interests policy.
Direct collaboration with industry or direct funding by a charity of a project that is
carried out by industry should be subject to a clear agreement and terms and
conditions outlining each partner’s expectations, particularly around intellectual
property and publications.
AMRC members support significant amounts of research, mainly in the university sector but also in their
own institutes or in other settings, such as NHS Trusts, research council institutes or other charity
institutes. Although much industry research is carried out ‘in-house’, links with university partners and
others are important and the advantages of being part of the wider scientific community and connected
with cutting-edge research are valued by industry researchers. There is also a certain amount of staff
transfer between universities and industry. Therefore, it is mostly through the university sector that
charity and industry interests concerning research intersect. In this section, we describe the current
environment, provide examples of the types of overlap and collaborations that may occur, illustrated by
a selection of case studies, and suggest issues that charities may need to consider.
The UK Government has introduced a number of initiatives and incentives to encourage universities
and business to collaborate more and these relationships have the potential to impact on all funders of
university research. This encouragement has lead to a significant rise in the exploitation of the
research generated by universities, NHS Trusts and research institutes in recent years. In 2003, a
review of university/business collaborations – the Lambert Review4 – showed that businesses that used
universities for information or as a partner were significantly more successful than those that did not.
While this is good news for industry, universities are publicly funded institutions, as well as being
exempt charities, and need to ensure that their aims and objectives are not compromised by these
interactions and that academic integrity is maintained.
The Lambert Review noted that US universities appeared to be ahead of their UK counterparts in
having clear codes of conduct governing university-business interactions and the review encouraged
UK universities to develop their own guidelines. Yale University School of Medicine developed a set of
stringent guidelines5 in 2005 that it expects its physicians to adhere to when interacting with the
pharmaceutical industry. These guidelines prohibit staff from accepting any form of gift from the
pharmaceutical industry, and detail procedures regarding provision of drug samples, scholarships for
trainees, industry support for events on the campus and disclosure of relationships.
Although the situation in the US is different to that in the UK, since direct advertising of prescription-only
drugs is permitted there, it is an important point of principle that the public must have confidence that
universities have systems in place for ensuring that their staff’s relationships with the pharmaceutical
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and other industries are transparent and that any potential conflicts of interest are avoided. While many
researchers are cautious regarding involvement with industry partners, such relationships can work well
and academic staff may be more reassured if their institutions had written codes of conduct in place.
AMRC believes that UK universities should be more explicit about the codes of conduct governing their
own staff’s interactions with industry. In addition, it would be helpful if universities were more open
about their existing relationships with industry partners, in general. For example, some charities have
policies in place that restrict their funding if a university is in receipt of funding from the tobacco
industry, and therefore universities need to be clear regarding their sources of funding. Cancer
Research UK’s policy on funding from the tobacco industry is appended (Appendix 4).
There may be implications for charities funding researchers with a diverse mix of funding sources,
particularly with regard to intellectual property (IP). While it should be possible to ensure that
obligations of researchers to those providing funding are clear from the outset, issues may arise. Some
of these will involve tension between the desire to protect (for future successful exploitation) versus the
desire to be open about the results of the research. At a number of stages in the research project, the
interests of industry may intersect with those of charities. Therefore, charities need to be clear about
how they will manage this early in the process, even though research projects may not have begun with
this outcome in mind.
AMRC has produced a briefing paper on IP rights (Appendix 5) and a position statement on IP and
biotechnology patenting (Appendix 6). For members that wish to adapt or use clauses pertaining to IPR
to insert into their own Terms and Conditions of grant, AMRC has developed a set of basic clauses that
charities may wish to use (see Appendix 7). There is a wealth of other sources of information available
for anyone interested in understanding the issues in this area and links have been provided to further
information about patenting and other forms of IP in the briefing.
Set against this background, a range of research interactions between charities and industry are
possible, and will determine the way that a partnership agreement is drawn up. Below a number of
examples are provided:
All AMRC members use peer review in the allocation of their research funding and will usually
appoint a number of external expert advisers to a peer review committee to assess applications
for funding. The membership of these committees is drawn largely from the academic
community, although many charities may also involve other stakeholders, such as patients.
Increasingly, applicants are asked to indicate whether the research may result in any IP and
committees may also be asked to comment on this, so that the charity has an early warning
system in place.
The way that academic research proceeds and most charitable organisations fund research is
reactive, rather than proactive, although charities with limited resource and in order to achieve
their charitable objectives may fund in very specific or narrow areas. However, most do not
‘commission’ research aimed at achieving particular goals; unlike most industry funding which is
goal oriented. This situation can be difficult for some charities which have strong demands from
patients who want treatments. Some charities which currently have no interactions with industry
partners would like to in order to stimulate research into the particular condition that they
The responsive nature of the research process and the way that charities fund research is
respected and trusted and the impact on the peer review process of proactive approaches to
research topics would have to be considered carefully by charities.
Would charities benefit if they included industry representatives on their scientific advisory
committees? This is clearly a sensitive topic for many charities. It is undoubtedly true that
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scientists working in industry have extensive knowledge and understanding of drug discovery and
development. Provided they are well informed of a charity’s strategic objectives, their advice can
be extremely beneficial to the peer review process. While there are concerns that industry
scientists might have conflicted interests, this can be equally true for active academic researchers
and a robust conflicts of interest policy should give sufficient protection to allow charities to benefit
from the additional expertise and insights that industry representatives can provide.
This term refers to research that is conceived and directed by the funder. A common example is
where industry engages a university to conduct a specific piece of research or funds a clinical trial
in the NHS. Universities will price such contracts to their advantage but industry will usually wish
to retain ownership of the IP. In most cases, this type of research will not impact directly on a
charity but charities may wish to be aware of the extent of this type of funding to any research
groups they support.
Programme-related investments (social investment)
Although not very common, there are examples of charities funding an industry partner directly to
develop products that would benefit patients/advance their charitable objectives. Such
arrangements have occurred in the USA (see Case study 4). In the UK, the Wellcome Trust has a
mechanism for funding companies to conduct technology transfer activities under its policy for
Programme-related Investments (PRI)
(for further details, see: http://www.wellcome.ac.uk/assets/wtd006142.doc).
Further information on PRIs and social investment can be found in the Charity Commission
guidelines at: http://www.charitycommission.gov.uk/supportingcharities/casi.asp.
This is the most common funding mechanism in universities and describes the usual relationship
between external funders and universities i.e. the project will be of interest to the funder but the
research will be formulated and driven by the academic team. Unless a wholly industry-funded
project, the potential for interacting with industry will only be at the conclusion of a project and
only if there is a potentially exploitable result. Co-funding of research projects between industry
and other partners is less common, although such arrangements exist. For example, the MRC
enables studentships to be part-funded by industry and also has grant schemes that industry and
university partners may apply for. The BBSRC also operates many collaborative schemes, such
as the LINK awards which fund up to 50% of the project costs where companies work with an
academic research partner.
Industry can provide vital resources to enable charities to fund projects that they may not have
had sufficient funding to support otherwise. As long as the charity manages the grant application
and peer review process in the usual way, it should feel confident that this may be an acceptable
way to fund some projects. Joint funding schemes between industry and charities are rare, yet
examples do exist where collaboration at this level has been managed successfully. Public-
Private partnerships such as the Medicines for Malaria Venture (MMV) have wedded public,
private and voluntary sector funding in pursuit of a common goal. MMV, whose contributors
include the Bill and Melinda Gates Foundation, the Wellcome Trust and the International
Federation of Pharmaceutical Manufacturers & Associations, seeks to provide support for the
discovery, development and delivery of new medicines to treat and prevent malaria.
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Case Study 4: Direct funding of biotech companies by non-profit organisations in the US
Many charities funding medical research have grown increasingly frustrated at the low levels of treatment
development stemming from the basic biomedical research which they support. It is often felt that
important breakthroughs derived from laboratory research are not being adopted and developed into
viable treatments by the medical and healthcare industries. As a result of these concerns, a number of
charities based in the US have implemented policies to address the issue directly.
Faced with the spiralling costs associated with bringing new drugs to market, pharmaceutical companies
may be reluctant to develop new treatments unless they can be certain of making sufficient profit. This
has meant that developments with a lower probability of success are not always pursued. For example,
drugs with a limited market, which may even apply to relatively common disorders, such as juvenile
diabetes, may lose out. As a result, some US charities, such as the Juvenile Diabetes Research
Foundation (JDRF), have provided funding for drug development by biotechnology firms, in the hope that
they will step into the translational research gap left by a cautious pharmaceutical industry.
In January 2007, JDRF announced that it would contribute US$2-3 million to support a phase II clinical
trial by the biotechnology firm MacroGenics Inc. The charity has provided funding to three other
biotechnology firms to develop treatments aimed at combating the nervous-system damage associated
with the disease, and at protecting and regenerating insulin-producing cells. JDRF board members are
very aware of the potential difficulties of such an approach, yet feel that the potential benefits outweigh
“We debated whether it was right for our money to go to a company that might make a profit," said JDRF
board member Michael White. "We're not unconcerned about that. But we've invested so much in
discovery, what we need now is to take these things to market.”
JDRF has not been alone in introducing such schemes. Other US charities, such as the Michael J Fox
Foundation for Parkinson’s Disease and the patient-led organisation Families of Spinal Muscular Atrophy
(SMA) have also initiated direct funding of biotech firms, supporting the development of novel treatments
that otherwise might have been abandoned. As Kenneth Hobby, the Executive Director of SMA,
observed, “With 10,000 SMA patients in the U.S., the market is too small for companies to see this
(disease) as a worthwhile bet unless we help them take a compound past the initial stages. If that means
funding a company, we have no problem with that."
The funding gap for translation from basic research to commercial application is widely recognised.
There are two main reasons for this lack of funding. Basic research is often “too early” or “too high-
risk” to be pursued by industry or investment sectors, which may not see a technology as attractive
until the risk has been reduced at ‘proof of concept’ stage. Alternatively, for applications without
large markets or for neglected diseases, the commercial drivers may be too weak to encourage
investment. University technology transfer offices are mindful of the challenges, but have difficulty
finding adequate resources. The dilemma is how to drive forwards translational research to ensure
new discoveries and technologies are able to realise their potential for the public good. A range of
schemes have been introduced to begin to bridge this gap, and some larger charities do have the
resource to fund some translational research. The Wellcome Trust, for example, has a number of
schemes to fund applied research projects at an early stage (see Case Study 5). There is also a
role for charities to provide links to those with commercialisation expertise to facilitate the
progression to downstream investment.
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Case Study 5: Wellcome Trust funding schemes to support innovation
The Wellcome Trust has provided a set of funding opportunities for researchers seeking to translate
research into practical health benefits. The primary purpose of translation awards that the Trust
introduced recently is to secure a healthcare benefit from the development of new technologies/products.
Many of these technologies will ultimately fail to reach the market so grants are made with no expectation
of a financial return. There are three schemes on offer:
Translation Awards are intended to encourage researchers and technology transfer professionals to
work in partnership to develop early-stage innovations.
Strategic Translation Awards are aimed at focussing the Trust’s own translation support in areas it
views as strategically important to its mission. Technology Transfer at the Wellcome Trust will proactively
seek applications from scientists conducting research in strategic areas who wish to work in partnership
with it to achieve the commercialisation of their inventions. Collaborating researchers will benefit from
access to the Wellcome Trust's considerable expertise and contacts in technology transfer.
Strategic Translation Awards in Seeding Drug Discovery The objective of the scheme is to develop
drug-like, small molecules that will be the springboard for further research and development by the
biotech and pharmaceutical industry in areas of unmet medical need.
Using products from industry for research
Many companies enable researchers external to the company to have access to materials, such as
new compounds, drugs, devices or equipment. Such ‘gifts’ usually have a two-way advantage – the
researchers obtain valuable tools for their research at little or no direct cost while the company will
gain vital feedback on its product. Despite such exchanges coming without a direct cost, there may
be a hidden cost to research done in this way. Some companies have tight restrictions on any
research outcomes arising using their products, including restrictions on publishing and/or ownership
of any IP. Most universities are aware of this issue and where non-commercially available materials
are provided by a third party there is often some room for negotiation over the Material Transfer
Agreement (MTA) which will govern this arrangement. Nevertheless, the provider is likely to have the
upper hand in such negotiations and, while the university will seek to secure an MTA which is not
overly restrictive, it is likely that the charity itself will have to reach a compromise with the company
over its ability to exploit any IP arising from the research.
There is also some potential, as outlined in Case Study 6, for industry to share some of its resources
with charities, when appropriate to do so. The example given outlines the possibility of utilising so-
called ‘back catalogues’ of compounds.
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Case Study 6: Utilising drug company ‘back-catalogues’
Clinical Development Partnerships (CDP) is a joint initiative between Cancer Research UK and Cancer
Research Technology, the charity's development and commercialisation arm. It aims to increase the
number of successful new treatments for cancer by taking undeveloped anti-cancer agents from
industry and putting them into clinical trials.
The initiative is targeted at leading pharmaceutical and biotechnology companies who have a large
pool of molecules that may have anti-cancer properties. However, these companies have to prioritise
which agents they take into clinical development - this leaves potentially effective treatments on
pharmaceutical companies' shelves.
CDP will take promising but 'de-prioritised' anti-cancer drugs into early stage clinical trials through
Cancer Research UK's highly experienced Drug Development Office. Effectively the charity will
'borrow' a drug from a company and conduct early clinical trials at no cost to the company. If the drug
looks promising, the company retains the option to develop and market the drug, but with the charity
receiving a share of any revenues.
There are many reasons why potential treatments do not make it to market. Science has progressed
so rapidly in recent years that there are more compounds available than commercial resources to
investigate them. And because drug development is so time-consuming and expensive - a new anti-
cancer drug can take in excess of 10 years and £500 million to develop - anything that doesn't look
extremely promising is not developed by a pharmaceutical company.
Harpal Kumar, Chief Executive of Cancer Research UK, added: "The drug companies have these
potential treatments trapped in their pipelines and we have the expertise and capacity to release this
potential. Their drug candidates coupled with our world-class network of trial centres and scientists,
offers a perfect partnership to achieve the greatest impact in the global fight against cancer."
Dr Richard Tiner, medical director of the Association of the British Pharmaceutical Industry, said: "This
is a simple, rapid and cost-effective way in which pharmaceutical companies can boost their product
lines. Companies will retain intellectual property rights to their original molecules and first option to
view the trial data, so should have no reservations about loaning these compounds to Cancer
Research UK for further investigation.
"The pharmaceutical industry is aware that it can't develop all the potential treatments it would like to
because of its huge pipelines, so this initiative offers companies a unique opportunity to maximise the
value of their shelved assets and develop new treatments for the benefit of cancer patients."
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General Principles of Partnership
Charities should be aware of Charity Commission guidelines ‘Fundraising through
Partnerships with Companies’.
Charities should discuss their principles for partnerships internally and with trustees
and other stakeholders before developing written guidelines.
In order to maintain independence and integrity, charities should develop their own
Charities should be open and transparent about the partnerships that they form.
Subject to staff turnover and other factors, charities should seek to ensure that they
have an established point of contact within the relevant company.
Written agreements should be drawn up at the beginning of a partnership; charities
should ensure that there is a mechanism for monitoring and evaluating the outcomes
of the partnership.
A number of organisations, including many member charities, have produced guidelines on how to
establish successful partnerships. Much of the advice is common sense but it can be helpful to review
what others have found works. In many instances, charities may have good working relationships with
a number of other organisations; however, if these are not formalised it may be timely to do so in order
to ensure that all parties involved understand the exact nature of the relationship and the aims and
expectations of each partner.
In the survey conducted at the end of 2006, members indicated that their independence and integrity
were of primary importance when working with industry partners. Other key phrases were: openness,
transparency, equity and mutual benefit. However, in order to translate these aims into practice it is
important to consider factors which may impede the attainment of these goals. What are the risks and
how are they best mitigated or avoided?
While many charities benefit from positive relationships with industry partners it is clear that exposure of
bad practice, particularly by the pharmaceutical industry, has led to many organisations being wary of
any involvement. The House of Commons Health Committee report on ‘The Influence of the
Pharmaceutical Industry’6 published in 2005 highlighted areas for improvement and made a number of
recommendations, many of which have now been adopted by industry, such as the revised ABPI Code
of Practice 2006 for the pharmaceutical industry. AMRC recognises that much improvement has been
made but charities should ensure that they have done their own research about the nature of any
organisation with which they are entering into partnership and be prepared to ask questions about any
areas that they feel are not clear.
Despite changes in the way that the pharmaceutical industry operates, the media focus is often
negative, with a number of articles claiming to expose unhealthy relationships between charities and
industry7,8. There is the assumption that the power-base is uneven, with charities being the
unsuspecting pawns of industry, and this inequality is seized upon, particularly when industry has made
a financial contribution to the charity.
Journalists writing such articles have clearly not been reporting on AMRC members. The results from
our survey indicated that, while AMRC member charities are aware of the media portrayals, they are
much more sophisticated than these articles imply. Charities view all partnerships with care and they
keep the objectives of the charity and the wishes of the trustees and patients at the forefront when
making decisions. Charities must report to their regulator, their trustees, their donors and the general
Herxheimer A, (2003) Relationships between the pharmaceutical industry and patients' organisations BMJ; 326:1208-1210 (31 May)
Marshall, J and Aldhous P (2006) Patient groups special: Swallowing the best advice? New Scientist; 2575: 18-22 (27 October)
“An Essential Partnership” Page 23 of 48
public; they are extremely cautious that their reputation, independence and integrity remains above
Guidance from the Charity Commission
Members should ensure that they are familiar with The Charity Commission guidelines - Fundraising
through Partnerships with Companies
(http://www.charitycommission.gov.uk/supportingcharities/com_fin2.asp); a summary of the
recommendations is provided below but for the full document, the link is provided above.
• Charities should recognise that their name is a valuable asset and should take steps to
protect their name and value it appropriately when entering a commercial partnership
• Charities and commercial interests need to clearly define their aims and expectations before
entering a partnership: charities should have in place appropriate systems to review and
monitor partnerships and manage any risks
• Charities should ensure that in entering a commercial partnership they are in compliance
with the legal requirements detailed in part II of the Charities Act 1992 and the Charitable
Institutions (fund raising) Regulations 1994.
• Charities should ensure that any commercial partnership is in their best interest and
represents a “fair deal” for the charity.
• As best practice, charities should highlight any commercial partnerships they have entered
into in their annual report and accounts
Many charities have developed their own guidelines and links to some of these are provided (Appendix
3a). However, when drafting guidelines, charities should be aware of their own particular
circumstances and the nature of the intended partnership, which may be very different from those
developed by other charities. This is likely to be the case particularly with respect to a charity’s local
networks, branches and support groups and how these may or may not interact with industry. Another
aspect to consider is who you may be dealing with from the company and whether they will remain the
contact throughout the process. In the big pharmaceutical companies, different departments may have
very different approaches. Many companies may use public affairs consultancies to deal with particular
aspects of their business, particularly lobbying, and, if this is the case, you need to establish early in the
process what the precise relationship is between the company and the consultants and whether they
are working for one or a number of companies. It is also important to take account of the global nature
of the pharmaceutical enterprise when working with UK-based industry. Many companies are directed
from their overseas offices and the priorities and pressures for them may not resonate with those of the
Charities should also be aware of guidelines produced by industry partners as these can provide helpful
information about the company and give insights into its reasons for collaborating. Links to a selection
of these is also provided at Appendix 3b.
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Charities seeking financial contributions from industry should have a thorough
understanding of the company, prior to seeking support.
If a company does offer financial support, the charity should be clear about the
company’s expectations and whether these are in line with the charity’s own
Pharmaceutical companies are required to indicate their sponsorship of an activity or
publication and charities must enable this but should also ensure that it is
Use of a charity’s logo or any of its materials by the industry partner must have prior
written agreement from the charity.
Charities must be prepared to state where they have received industry support on all
publicity and other materials associated with a particular programme.
Charities should report their collaborations and the financial contributions received
from industry in their annual reports and accounts.
Charities should, where possible seek to work with a number of industry partners
when producing educational material or with the relevant trade body.
Charities should ensure at the outset that they retain editorial control over the
content of any publications or materials which bear their name, but must exercise
caution that they do not endorse individual treatments.
The Charity Commission defines sponsorship as follows: “Under this type of agreement a company is
in effect paying a charity to publicise the company and the fact that it has contributed to the charity.
The company agrees to meet some or all of the costs of, for instance, one of the charity’s publications,
fundraising events or projects. In return the charity will publicly acknowledge the company’s
contribution. The company again hopes that its visible association with, and financial support for, a
charitable cause will improve its image, or promote and sell its products. The charity benefits from the
sponsorship payments and, it hopes, from increased exposure of its name and cause in the company’s
own advertising of its support for the charity.”
A survey conducted by the Institute for Philanthropy9 found that over half of the people it questioned felt
that big business should support charities but the Charities Aid Foundation’s (CAF) annual report
‘Charity Trends’, reveals that corporate support is not nearly as generous as the public may believe.
The report found that corporate donors overall contributed just under 3% of UK charity income.
The AMRC survey of members’ interactions with industry revealed that the majority (70%) of those who
responded had received funding from industry in the form of event sponsorship, while provision of
educational material and patient information and ‘other’ forms of support were equally common at 34%.
Only half of the charities responding to the survey received any funding from industry but for those that
did industry donors constituted less than 4%, on average, of a charity’s total income.
Although the financial contribution from corporate supporters may be small, many charities view these
relationships as important since they may raise the charity’s profile in other ways and could offer on-
going support to enable charities to promote their own agendas more effectively. The value of such
‘gifts-in-kind’ need to be taken into account, as well as scrutinised carefully. One of the major
considerations for charities is the attitude of their main stakeholders and their trustees to potential
corporate supporters. Therefore, checking a company’s credentials and gathering the views of charity
stakeholders is essential before entering into partnership.
Issues around sponsorship
Corporate sponsorship is often in the form of a donation which enables charities to fund scientific
meetings or events for patients or supporters, patient information leaflets or other educational materials.
“An Essential Partnership” Page 25 of 48
In most cases, charities approach industry to ask for such contributions and many charities have a
policy of seeking support from a range of industry donors rather than a single company. As with all
forms of interactions, both types of organisations need to be clear about the perceptions, motivations
and outcomes that such partnerships may have.
The issues when working with pharmaceutical companies, which are not permitted to use such
opportunities for ‘disguised marketing’, are now well aired and the limits of their interactions are detailed
in the APBI Code of Practice. The ABPI Code requires pharmaceutical companies to have written
agreements, specifying the funding involved, if appropriate, for every significant activity with a patient
organisation. In addition, pharmaceutical companies must also make public a list of all patient
organisations to which they provide financial support. However, there is a lot of confusion about what
the "written agreement" should look like and this is resulting in pharmaceutical companies asking
charities to sign their terms and conditions. If charities are intending to work with the pharmaceutical
industry they must be prepared and have their own policies and agreements in place rather than
signing up to a company policy. In fact, some companies prefer to do this too. The ABPI briefing
paper, ‘Patient groups, industry support and medicines’
(http://www.abpi.org.uk/category.asp?Category=2) reiterates these points.
One of the issues raised by charities is that many pharmaceutical companies view their support as a
charitable donation towards a project rather than commercial sponsorship. However, the need to be
open and declare any support provided requires that the relevant industry logos are placed on any
materials produced, which benefits the company. Another area of concern is the growing trend for
pharmaceutical funding to be restricted income. When pharmaceutical companies insist on limiting
funding to particular projects, charities are not able to charge the full value of sponsoring an activity,
which includes an amount to take into account the marketing benefit to the company. If charities were
selling sponsorship of a project to a company in the retail or finance sector, for example, then they
would charge the full commercial rate.
When working with industry support to provide information to patients, charities may want to raise
awareness of particular conditions, help patients and clinicians to identify symptoms and outline
treatments and options available to them. The ABPI has produced a number of publications in
collaboration with a range of stakeholders, including charities, which are not funded by any one
pharmaceutical company and many charities have indicated that an ‘industry funding pot’ for supporting
activities of this sort would be welcomed. It may avoid many of the issues associated with dealing with
either a single or multiple industry partners. A project is underway – the Medicines Information Project
– which has developed the Medicines Guide web site at:
http://medguides.medicines.org.uk/default.aspx. This is an independent not-for-profit group, funded by
over 30 industry partners, and has a number of stakeholders on its project board. It is being developed
in partnership with NHS Direct and with the support of a wide range of organisations and aims to
provide people with information about medicines, conditions and the different treatment options
Charity endorsement of products
Charities endorsement of any products must be considered carefully. The use of a charity’s brand or
logo to support a product will create a variety of associations in the public’s mind and not all of them
may be positive for the charity. Charities wishing to provide such endorsements may decide that it is
within their charitable aims to do so and where it has the necessary expertise to do so, it may be
performing a useful public function. However, if companies are seeking such endorsement to trade on
a charity’s good name and reputation then charities must exercise great caution.
Specific mention should be given here to cases where industry provides funds for conference
attendance on the part of charity employees or stakeholders, which is perhaps one of the most frequent
forms of industry sponsorship among medical research charities. This provides a more indirect
mechanism by which a company can provide support for a charity’s activities and, providing the charity
“An Essential Partnership” Page 26 of 48
is transparent about its source of funding, this kind of activity should not pose any serious issues. Once
again, when in receipt of funding from the pharmaceutical industry consideration should be given to the
relevant clauses in the ABPI Code of Practice, which, for example, guard against the sponsor paying for
“lavish or deluxe” venues or travel arrangements.
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Policy & Campaigning
Where a charity becomes involved with a collaborative lobbying campaign, the
charity should ensure that the activity is in line with its charitable strategic
The terms of any such collaboration should be governed by a written agreement
between the two parties which has been drawn up by the charity.
When working with third parties which may be funded by or otherwise linked to
industry, charities should seek to ensure that, wherever possible, they are aware of
any such links and that both parties are open and transparent about their existence.
Medical research charities, pharmaceutical companies and academia have the shared aim of ensuring
that the UK medical research environment is supported by government and not threatened by those
with an anti-research agenda. These shared agendas, such as the use of animals, human tissue,
embryonic and “cybrid” stem cells in medical research and the adoption of new treatments by the NHS
have been the subject of lobbying and campaigns by both the charity sector and industry. Common
agendas assist the formation of partnerships, as charities and industry seek to work collaboratively in
furthering their objectives. As in other areas, charities need to examine carefully whether joint lobbying
on these sorts of issues would strengthen their position.
Examples of collaboration on issues of policy or lobbying
Funding Charitable Campaigns
Charities are a powerful lobbying group and their opinions, particularly those of groups which
directly represent patient’s needs and wishes, are given considerable weight by government and
other stakeholders. In an examination of the influence of lobbying groups over NICE health
technology appraisals, a recent report10 found that patient groups tended to be more successful
than industry, with 64% of their appeals on NICE decisions being accepted as compared with a
40% success rate achieved by industry. However, it is interesting to note that in virtually all cases,
these successes were achieved when a patient group and a manufacturer appealed jointly on a
particular decision. Where either a patient group or a manufacturer campaigned alone, their
appeals were almost always rejected.
This being the case, it is only to be expected that many companies with a vested interest in a
particular healthcare agenda will seek to align themselves with one or more medical charities in
order to further that agenda. Although at times companies and healthcare charities may share the
same goals, it is important that the interests of their patient group are the driving focus for
charities and that they are not unduly influenced by companies.
Joint working on patient campaigns can be misinterpreted by the media and other external
groups. It is crucial that charities make clear the motivation of their involvement is patient need
and not industry pressure.
Duckenfield M, Rangnekar D (2004) The Rise of Patient Groups and Drug Development – Towards a Science of Patient Involvement
School of Public Policy, University College London
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Case Study 7: Herceptin
In 2005, clinical trial evidence presented at a scientific conference demonstrated the significant benefit
Herceptin could have in reducing the chances of recurrence in some women with HER2 positive early
breast cancer. As it became apparent that some women were being denied access to the treatment as
their PCT refused to fund the drug, several patient groups began a high profile campaign to ensure
access to this new treatment for women who could benefit.
The campaign was a success and Herceptin was fast tracked by the National Institute for Health and
Clinical Excellence (NICE) so that guidance could be issued as soon as possible after the drug was
licensed for use in the UK.
Breakthrough Breast Cancer, Breast Cancer Care and CancerBackup had all received minimal funding
from Herceptin manufacturer Roche for specific projects unrelated to the campaign. However this was
misrepresented by some media and suggestions made that dependence on funding from
pharmaceuticals had influenced decisions by charities to get involved in campaigning.
As discussed in the General Principles of Partnerships section of this document, many charities
have a clear policy on accepting support (financial or other) from pharmaceutical companies and
many publish details of any funding received on their websites. Having such a policy, being open
and transparent about how much funding is received from companies and explaining how it is
used should help avoid criticism over any future campaigns supported by both patient groups and
Industry-led campaigns involving charities
In its response to the House of Commons Health Committee consultation on the influence of the
pharmaceutical industry, Cancer Research UK raised the issue of industry-led lobbying as being
“The increased emphasis on the development of lobbying groups by pharmaceutical companies
to raise interest in the adoption of drugs or techniques is of concern. This can result in groups or
individuals pushing for action in a particular area, without adequate consideration of the relevant
Although industry funding for a charity’s lobbying activity can often be a valuable asset to the
organisation in furthering a campaign, charities must take care to ensure that they are not co-
opted into supporting the industrial partner’s agenda to the detriment of their own interests or
those of the patients they may represent.
We hope that such unbalanced partnerships are rare and any that are attempted should be more
difficult to conceal, with the ABPI guidelines and the increased openness regarding the
pharmaceutical industry’s interactions with patient groups. Our survey of charities indicated that
AMRC members are well aware of the potential pitfalls when working with industry; with the
majority of charities taking the lead. While AMRC acknowledges that in some situations there
may be good reason for charities to participate in a lobbying campaign initiated by industry,
charities should take extra precautions. In particular, they should take time to consider the
evidence behind the campaign independently and ensure that their interests, and those that they
represent, would be well served.
Lobbying groups established by industry
In some cases, industry, the pharmaceutical industry in particular, has taken a more direct
approach to securing advocacy for its products. This has sometimes taken the form of a
pharmaceutical company establishing an apparently independent organisation to lobby on its
behalf. An example of this kind of activity was the establishment of ‘Action for Access’ by Biogen
in 1999, which lobbied for the provision of one of its products, Interferon Beta, in the treatment of
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multiple sclerosis patients.11 In this case, the then Medicines Control Agency (MCA), in response
to pressure from the Multiple Sclerosis Society, ruled that the campaign was an example of illegal
promotion, and abolished Action for Access.
Many of the larger pharmaceutical and biotechnology companies have sought to pursue their
interests in areas of policy and public relations through the use of third party public affairs groups.
Use of a public affairs agency allows industry to maintain distance between itself and a political or
lobbying campaign, while many such agencies have become adept at forging links with patient
groups and hence in bringing charity and industry voices together. An example of such a group is
the PR organisation Weber Shandwick, which has been prominent in organising lobbying
campaigns on behalf of health care industries in the EU. Indeed, the extent of its interactions with
European-based patient groups such as the European Patients Forum (EPF) has provoked
concern from some commentators.12
As emphasised throughout this document, the fact that these organisations have close ties with
healthcare industries need not, of itself, be cause for concern. However, the fact that public affairs
groups can act as third party surrogates for the views and agenda of industry may lead some
charities to unknowingly forge links with healthcare industries (see Case Study 8), thus
compromising the requirements for transparency and openness around such interactions, as set
out in AMRC’s guiding principles.
Medical research charities can clearly form productive partnerships with industry when lobbying in
pursuit of a common aim. Where groups are established and funded solely by industry yet purport
to be patient based, AMRC considers that this can undermine the credibility and status of genuine
patient groups: when working with such organisations, AMRC members should be confident that
they do so in the spirit of openness, transparency and integrity which underpins this document
and other guidance in this area.
Boseley S. Drug firm asks public to insist NHS buys its product. Guardian 1999 Sept 29.
Van Lennepkade J Does the European Patient’s Forum Represent patient or industry interests – A case study in the need for mandatory
financial disclosure. Health Action International (2005)
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Case Study 8: European patient organisations and links with industry
Herxheimer (2003) alleges that two widely recognised international patient organisations, GAMIAN
(Global Alliance of Mental Illness Advocacy) Europe and IAPO (International Alliance of Patient
Organisations), were established by and retain strong links with the pharmaceutical industry.
GAMIAN describes itself as an international patient driven confederation of national mental health
patient organisations across Europe, its purpose being: “to encourage and promote information,
education and awareness on current knowledge of the treatment and support available to those affected
by mental illness having regard to the latest evidence based material.” It aims to do this through raising
the awareness of symptoms as well as the availability of treatments and supports the implementation
and dissemination of research projects cognizant with these aims. Herxheimer states that GAMIAN was
founded by the pharmaceutical company Bristol-Myers Squib, and that GAMIAN Europe, an offshoot of
the original GAMIAN, retains links with industry. However, GAMIAN Europe’s website lists the founding
members of GAMIAN as follows: Fondazione IDEA, Freedom from Fear, Equilibrium, Club D&A, France
Depression, Depression Alliance, Hieronimus, OCD Foundation, National DMDA, Ananke, Obsessive
Action, Manic Depressive Fellowship-Wales. The website makes no mention of industry links nor does it
provide easily accessible information as to their current funding.
IAPO is a “unique global alliance” of patient organisations, with a mission to improve patient centred
healthcare. IAPO is open about its industry funding, which since its inception, has been substantial (van
Lennepkade states that it is 99% industry funded ). The organization has a well defined framework for
collaborating with industry, whereby funds received on a non-restrictive basis entitle the industry partner
to “numerous benefits and entitlements”. Industry partners are delegated as “Gold”, “Silver”, “Bronze” or
“Standard” according to a sliding scale of donations. Among its Gold members IAPO lists
GlaxoSmithKline, the Medtronic Foundation, Novartis and Pfizer. Nevertheless, while Herxheimer claims
that the organization was founded by Pharmaceutical Partners for Better Healthcare, a consortium of
pharmaceutical companies, IAPO’s website makes no mention of this group, citing its foundation by an
alliance of patient groups.
Andrew Herxheimer Relationships between the Pharmaceutical Industry and Patient groups BMJ 2003; 326; 1208-1210.
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1. Industry Working Group – remit and members
2. Survey of AMRC members interaction with industry 2006
3. CR-UK policy on tobacco funding
4 a Example policies and guidelines from member charities
b Example policies from industry
5. AMRC briefing paper on Intellectual Property Rights
6. AMRC policy on Intellectual Property and Patenting in Biotechnology
7. AMRC guidance on Terms and Conditions for IP
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Industry Working Group – Remit & Members
Terms of Reference
Medical research charities recognise that the pharmaceutical and biotech industries play an important
role in delivering new treatments and improvements in health care but AMRC has identified that there is
often uncertainty about how to manage these relationships and how they are perceived. AMRC
Executive Council has agreed that this would be an appropriate time for AMRC to explore these issues
in more depth but it was considered that the discussions should be broadened to include
representatives from industry and academia as well as member charities. A specialist working group
has been established to help AMRC explore the issues and identify policy priorities and potential areas
for advice and guidance. The working group will report to AMRC Executive Council and its membership
is drawn form industry, academia and member charities.
The working group will:
Advise AMRC Executive Council on the key issues for medical research charities
Advise AMRC on policy priorities for AMRC or for others
Help shape AMRC future activities including potential partnerships, networks and guidance for
Membership (to be confirmed)
Dame Bridget Ogilvie
Dr Ted Bianco, Director of Technology Transfer, The Wellcome Trust
Simon Denegri, Chief Executive, AMRC
Richard Driscoll, Director, National Association for Colitis and Crohn’s Disease
Jeremy Hughes, Chief Executive, Breakthrough Breast Cancer
Alison Macdougall, Solicitor, British Heart Foundation
Maxine Taylor, Executive Director of Policy and Communications, Cancer Research UK
Dr Jean Bradbury, Executive Director, Science Policy and Communications, Pfizer
Dr Barry Furr, Chief Scientist and Head of Project Evaluation Group, AstraZeneca
Dr Trevor Jones, Recently Director General ABPI and former R&D Director Wellcome plc
Aisling Burnand, Chief Executive, Bioindustry Association
Professor Christopher Higgins, Academy of Medical Sciences and Group Head, MRC Clinical
Dr Lee-Ann Coleman, Head of Policy Research, AMRC
Dr Sophie Petit-Zeman, Director of Public Dialogue, AMRC
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AMRC Survey of Members 2006
Results of the AMRC survey on member’s links with industry
56 AMRC member charities responded either by via e-mail (those without links) or by completing an
- 51 charities completed the survey; 5 sent e-mail responses
- 31 charities work with some form of industry and some work with more than one type – 87% of
respondents work with pharmaceutical companies, 32% with biotechnology companies and
26% with ‘other’ industry.
- In the majority of cases (69%) collaboration was in the form of event sponsorship, although
both the provision of educational material and patient information and ‘other’ forms of support
were equally common at 34%.
- In the majority of cases (83%), the charities approached industry and most (73%) have a code
of practice, either drawn up by them or written in collaboration with the industry partner.
- ABPI Code of Practice - 60% were aware of it (32 charities responded)
- 54% received a proportion of their income from industry (35 charities responded)
- Funding received ranged from less than 1% to 17% of total income (Average = 4%; n=19). It
was rare for charities to receive funding from just one company, with the norm being more than
five. The majority (71%) report such income.
- Slightly over a quarter (28%) of charities have a publicly available policy on working with
There were two key words that emerged from charity’s responses to the issues that interaction with
industry raised - independence and integrity. Charities agreed that openness and transparency is
important for all parties involved in working together and they agreed that working together is possible
with mutually agreed goals.
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CR-UK Policy on Accepting Funding from the Tobacco Industry
Cancer Research UK - Terms and Conditions
Tobacco industry funding to Universities
Cancer Research UK does not endorse tobacco funding under any circumstances. The following guidelines
deal with the situation in which Cancer Research UK will not provide funds for university research.
In pursuit of its mission, Cancer Research UK wishes to promote the highest ethical practices in scientific and
medical research. Mindful, therefore, of the immense danger to health and life caused by tobacco, it wishes to
do everything it can to avoid links, whether direct or indirect, with the tobacco industry, and to oppose tobacco
promotion and use in all its forms. Therefore in 1998 Cancer Research UK (through its predecessor body The
Cancer Research Campaign) put in place the following joint protocol, endorsed by the Committee of Vice-
Chancellors and Principals (CVCP -subsequently known as Universities UK).
Cancer Research UK will not provide future research support to any institution in which those who are or would be
supported by Cancer Research UK funds are working in such proximity to others supported by tobacco industry funding
that there is any possibility or likelihood that facilities, equipment or other resources will be shared. Funding in a quite
different faculty or school of the university or institution is not covered by this protocol.
Tobacco industry funding includes funds from a company or group of companies engaged in the manufacture of tobacco
goods; and funds in the name of a tobacco brand whether or not the brand name is used solely for tobacco goods; funds
from a body set up by the tobacco industry or by one or more companies engaged in the manufacture of tobacco goods.
The following do not constitute tobacco industry funding for the purposes of this protocol:
• Funding from subsidiary and associated companies unless they bear the offending name or it is intended or likely that the
parent or associated company with such a name will publicise the funding
• Anonymous donation
• Legacies from tobacco industry investments (unless the names of a tobacco company or cigarette brand are associated
• Funding from a trust or foundation no longer having any connection with the tobacco industry even though it may bear a
name that (for historical reasons) has tobacco industry associations
• Donations given to the university for general use by the university entirely at its discretion
Funding falling within this protocol covers money provided or used for all or any of the costs of the research, including
personnel, consumables, equipment, buildings, travel, meetings, and conferences, running costs for laboratories and
offices, but not meetings or conferences unrelated to a particular research project.
Cancer Research UK remains firmly in support of the joint statement of 1998 with the Committee of Vice-Chancellors and
Principals of UK Universities, in particular that:
“Funding which gives favourable publicity to a tobacco company or interest, or which promotes tobacco use or which is
likely to show, or be capable of showing, tobacco, tobacco use or the tobacco industry in a favourable light should be
rejected.” (‘CVCP Guidance on Tobacco Funding’, in ‘Tobacco Industry Funding to Universities – A Joint Protocol of
Cancer Research UK and the Committee of Vice-Chancellors and Principals of UK Universities’)
Cancer Research UK is currently reviewing its Code of Practice on Tobacco Industry Funding to Universities. A
consultation document, which contains the full text of the 1998 joint protocol, can be found at the following website:
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A number of charities have developed guidelines to govern their relationships with commercial and
industry partners. AMRC members may wish to consult these, alongside the recommendations made
in this document, when preparing their own guidelines. AMRC considers that when such documents
have been developed they should be available publicly and be easy to access from a charity’s web site.
Breakthrough Breast Cancer – provides a page of information about their work with and sponsorship
received from pharmaceutical companies, along with a link to their policy on financial support from
Breast Cancer Campaign – their policy is available on their web site and they also detail the level of
support they receive from pharmaceutical companies:
To access other policies from member charities please go to the AMRC web page on industry
A number of pharmaceutical companies also make available their policies and guidelines for working
with patient groups and links are provided to a selection:
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AMRC Briefing Paper – Intellectual Property Rights
Medical research charities and the exploitation of research
This briefing paper is intended to provide an introduction to intellectual property rights (IPR) for AMRC
member charities and to clarify AMRC guidance and policies already in existence. This is a complex
area and one that is difficult to cover comprehensively in a short paper, therefore links to further
information are provided.
What is intellectual property and why does it have to be protected?
The term intellectual property (IP) refers to the output of creative endeavour with potential commercial
use which can be identified and protected. Intellectual property rights (IPRs) are an essential step on
the path to ensuring that a product can be used commercially and they exist primarily to give
developers and producers, competing in a free market, the right to make, distribute or utilise products or
processes embodying particular ideas and symbols. There are many forms of ‘right’. These might
include patents for inventions, trade secrets, know-how and other confidential information, copyright,
design rights and trade marks. Each right is separate and has a different form of protection and
Patents are the form of IPR most frequently encountered in the research environment and some parties
argue that such rights provide encouragement for research effort, although most researchers in medical
and health research would probably not recognise this advantage as their motivating factor for doing
research. Similarly, universities, publicly-funded research institutes and NHS Trusts undertake
research to generate new knowledge and disseminate it freely in the public domain, and although they
recognise the benefits of exploiting IP and many do this actively through their own technology transfer
offices, generating income through this activity is not their primary purpose. The UK Government has,
in recent years, stressed the economic advantages of using scientific knowledge to create wealth.
Fostering knowledge transfer between universities and business has formed an important element in
the Government’s science strategy. Universities receive additional funding through the Higher
Education Innovation Fund (HEIF) to enable them to support knowledge transfer activities and from
2007, the Higher Education Funding Council for England will distribute a fund of £60 million to English
universities on the basis of their industry income.
Patents provide a monopoly right to the exclusive use of an invention for a period of up to twenty years
from the date of filing. If the owner of the patent does not wish to or is unable to exploit the invention,
they can transfer the technology to others. By transferring the rights, income can be generated through
a licensing deal or by negotiating a lump sum payment. It should be kept in mind that it is usually very
difficult to assess the value of a patent and many inventions, despite the enthusiasm of the inventors,
fail to generate any revenue. The costs of protection and enforcement may also be considerable and
impact on potential profit.
To be patentable, an invention has to be new, include an inventive step which is not obvious, and be
capable of industrial application.
To be regarded as 'new', an invention must not have been made public in any enabling way
before the date on which a patent application is filed. This applies as much to public lectures,
seminars, informal discussions with other scientists, abstracts, internet forums and the like, as to
An 'inventive step' means progress in technological originality from present practice and ‘not
obvious’ means that a person skilled in that field should not be able to arrive at the advance
plainly or by employing obvious logical steps.
Industrial application implies that the invention should be a product or industrial process.
Inventions in particular areas are not patentable and these include, among others: discoveries of
natural or physical phenomenon, methods of surgery, diagnosis or therapy where these are practiced
on the human body, or animal or plant varieties.
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Patent law requires that the above conditions are met and this is where those unfamiliar with the
process of patent filing encounter the greatest problems. The requirements of novelty, inventiveness
and industrial applicability must be proven and the legal definitions of these terms mean that they are
sometimes incompatible with a researcher’s way of thinking and working. Patent attorneys may also
disagree over the precise applicability of the criteria to particular cases. Applications for patents are
made to the UK Patent Office, which examines requests and, if these meet their requirements, a patent
is granted. In 2005, the Patent Office granted over 3,700 patents from a total of nearly 17,500
applications. Patents are published usually about 18 months after they have been filed and therefore,
they add to the body of knowledge in that area.
It should also be kept in mind that patent rights are territorial. That is, they apply only in the country
where they are filed and different countries may have different requirements. In the USA for example,
patent law uses the ‘first to invent’ rule, rather than the ‘first to file’ approach used in other countries.
This means that if a proper audit trail has not been kept (usually in the form of well documented
laboratory notebooks) then it may be difficult to challenge a patent filed in the USA after the date of one
filed in the UK, unless the applicant can prove an earlier invention date. There are organisations that
enable patents to be filed in multiple territories. The European Patent Office allows inventors to make a
single application that protects the patent in over 30 European countries, while the Patent Co-operation
Treaty enables protection in many countries through the World Intellectual Property Organisation. The
UK Patent Office enables applicants to make multiple applications through these offices.
In December 2005, the Government commissioned an independent review of the intellectual property
framework in the UK - it reported at the end of 2006. The aim of the ‘Gowers Review’ was to expose
disincentives in order to improve efficiency and competitiveness and it highlighted a number of areas
where changes could be made or better clarification would help resolve uncertainties. For example,
there is an exception to patent law that enables academic researchers to examine, test and build upon
inventions but the review noted that this exception needs to be better explained, especially in light of
the increasingly commercial nature of the transactions between universities and business.
How does this affect charities?
Most medical research charities have objects which focus their research activities on the improvement
of human health or the prevention, alleviation or cure of a particular disease or group of related
conditions. Many people assume that because charities fund research for public benefit that this aim is
incompatible with issues of protecting IP and commercial exploitation. Although charities cannot
support a piece of research solely for financial gain, there may be circumstances where a charity’s
objectives can be best achieved by ensuring that IP is protected and/or exploited.
With the exception of single institute charities or those that have the capacity to exploit inventions from
researchers they employ directly, most charities fund research carried out by employees of universities,
research institutes or NHS Trusts. Therefore, under most circumstances where charities are the
external funders of the research, AMRC advises that they should not seek to own or exploit the IP
themselves. Charities are not under any duty to acquire IPR – provided that the research falls within
the objects of the charity, making the grant fulfils the trustees’ obligations.
However, it is important to remember that IPRs could not have been generated without the charity’s
financial support for the original research and they should share in the royalties and other income
arising from any exploitation that occurs. Charities should recognise that they will rarely be the sole
funders of the research and a revenue sharing model may need to be agreed, based on the relative
contributions from a number of organisations and taking into account the costs that have already been
Despite these issues, charities and their trustees do have an important role to play and there may be a
range of circumstances and motivating factors for becoming involved in the commercial exploitation of
research. These may be:
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to achieve public benefit of the research through the practical application of research
to provide leverage and a stronger position to influence the use of research outcomes;
to motivate and retain key scientists in the UK;
to generate additional income.
The complexities arise from the need to co-ordinate three cultures i.e. that of the funder(s), the
researchers and the host institution and the legal profession. However, with a better understanding of
the requirements and the restrictions governing these sectors it is possible to achieve satisfactory
outcomes in this area. Most universities and the NHS, with the establishment of the NHS Innovation
Centre and nine hubs which work locally with NHS Trusts, have technology transfer offices with the
purpose of auditing and exploiting the institution’s IP. These offices also play an important role in
educating staff about IPR and what they need to do to ensure that they follow the requirements in the
event that they wish to protect their inventions.
How will a charity know if research it has funded has led to an invention?
There are a number of ways in which charities can seek information regarding the commercial potential
of research they have funded.
In order to have an ‘early alerting’ mechanism many charities include a question on the
application form asking the researcher whether they envisage any potential inventions or
applications arising from the research they are proposing. This question can have wider
relevance for charities that also wish to identify research outcomes that may not necessarily
have commercial potential but that may result in benefits to patients in the short to medium
Scientific advisory panels may be invited to comment further on the potential of applications
and once identified, those grants could be monitored at appropriate intervals.
Annual and final reports submitted by grant holders are another way to gather information
and it may be necessary to ask the question specifically about exploitable results.
Of course, the host institution should alert the funder(s) and seek permission in the event
that they identify any IP.
What should charities do?
AMRC recommends that charities ensure that host institutions are aware of the charity’s interests and
policies by including relevant information in the terms and conditions of award. Both charities and host
institutions must consider whether protection and exploitation of the IP is the most appropriate means of
achieving public benefit.
AMRC recommends that the following areas should be addressed:
Explanation of the charity’s role and interests.
Requirement that the host institution has mechanisms in place for monitoring IP and notifying
the funder in the case that such arises.
The host institution should have clear guidelines for staff and students regarding IP issues.
A mechanism for managing IP should be outlined and the host institution should enable the
funder to reclaim the IP if the host chooses not to exploit. Ownership should be stated – in
most situations AMRC recommends that charities not seek to own the IP.
Expectations about timing of the process should be given and a requirement that publications
should not be unduly delayed should be stated.
An outline of the charity’s expectations regarding revenue sharing should be provided, though in
practice this may need to negotiated on a case-by-case basis.
The role of the research institution
As mentioned above most universities and the NHS have their own departments or units responsible for
technology transfer. This unit may or may not work closely with the research grants and contracts
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office and it can be helpful to be aware of who the contact is within the technology transfer unit – they
are likely to be different from the person who signed the finance section of the grant. Universities
should be aware that charities funding medical research are required to monitor the outputs and
outcomes of the research that they fund and may need to report to a wide range of stakeholders,
including patients. The interest of charities therefore is important and they should be notified by
institutions about developments arising from the research they have funded.
Research institutions should have clear guidelines for staff and students on ownership of IP and on
their procedures for the identification and protection of such. Most research institutions do not claim
ownership of academic copyright but retain ownership of other forms of intellectual property created by
employees in the course of their employment.
It should be noted that research students are not normally employees of a research institution. Thus,
the IP generated by the student may belong to the student unless he/she has signed a contract
assigning IPRs to the research institution or other body, which has become an increasingly common
practice. However, there may be special considerations to take into account regarding PhD students,
as any delays in the publication of their thesis could be detrimental to them if not managed in a timely
Although the institution may own the IP and may expend significant resource in protecting it, patent law
also recommends that there should be recognition of the role played by employee inventors. It
suggests that when there has been a measure of fair return from patents and where employee’s efforts
have brought 'outstanding benefit' to the employer, it is fair that compensation should be awarded.
AMRC would expect employers to offer individual researchers an appropriate share of any revenue
generated if their research leads to profitable commercial development.
What are spin-out companies?
Spin-out companies are being used more and more by the university sector as a means of
commercially exploiting the IP owned by the institution. Spin-outs are independent businesses which
require substantial additional commitment from the academics that initiated them. The university often
invests time and resource in helping to establish the company, although not without the expectation of
being a significant shareholder. Not all spin-outs will succeed and not all research is suited to this type
of vehicle for exploitation. In addition to requiring staff with business acumen, spin-outs also need
funds to develop the business.
Most charities do not fund this type of venture but there are a variety of schemes available from other
sources that provide seed funding, start-up funds etc. Determining how the revenue generated will be
split between the university, the researchers and the investors can be complex and there are no
standard equity distribution models in this area. Again, while it would seem reasonable for the major
funders of the research which led to the IP to be eligible for a share in the equity and/or share options
this is not always acknowledged by the spin-out. In theory licensing of the IP already generated is one
way of ensuring that the original funders see some returns but in practice licences granted to spin-outs
on IP already owned by the institution are usually made on terms that are very favourable to the spin-
out. Charities are encouraged to seek more information from the university if a spin-out is being formed
on the basis of research it has supported.
Is there an inherent conflict between IP and academic research?
Nondisclosure of the invention is a requirement for patent filing and therefore delays to academic
publication can arise and cause disquiet amongst the research community, which cite this as one
of the ways in which the patent process inhibits research. However, if all parties are alerted in a
timely fashion it should be possible to file a patent and avoid undue delay to publication.
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Since charities too have a duty to disseminate useful research findings there has been some
concern regarding their position should the need to protect research outcomes cause a delay in
publication of the results. Care has to be taken to ensure that the patent is properly registered
and in ideal circumstances the planning process should allow for a period of 30-60 days for the
filing of a patent prior to publication. If this is not done, the process of protection may have to be
rushed through before publication by using the right to file a provisional application which can be
followed by a detailed application within twelve months. Such speed is possible in practice but it
One of the issues with a system that prohibits others from using a patent without permission is the
potential for competitors to obtain the patent in order to inhibit further commercial development.
Such a situation may result in patients being denied the benefit of a new technology or drug.
Charities can request the right to refuse permission for the institution to enter into agreements
with third parties that don’t meet their standard conditions.
What is the impact of background IPR?
There may be IPR governing the research already being undertaken that may impact on the
institution’s rights should they wish to file a patent. The most common example is the use of a
product in the conduct of research that may itself be protected in some way. In some cases
researchers have been unaware that a product ‘given’ to them by a company came with
restrictive clauses and may even prohibit the researcher from publishing the results freely. It is
therefore important to identify any background IPR that may impact on the future exploitation of
the project. Most universities are aware of this issue and have mechanisms in place to ensure
that where non-commercially available materials are provided by a third party that a Material
Transfer Agreement has been signed which is not overly restrictive and will enable the institution
to exploit any IP arising from the research.
AMRC policies and position statements
AMRC has revised its position statement on patenting and biotechnology inventions, and has
developed guidance on terms and conditions of grants that cover this area and which members may
adopt and adapt to suit their needs.
Government-backed UK Intellectual Property: http://www.intellectual-property.gov.uk/
UK patent office http://www.patent.gov.uk
European Patent Office http://www.european-patent-office.org/index.en.php
World Intellectual Property Organisation http://www.wipo.int/portal/index.html.en
AURIL is the representative body in the UK for all knowledge transfer practitioners
European IP issues: http://www.ipr-helpdesk.org/
Gowers Review of Intellectual Property 2006:
NHS National Innovation Centre: http://www.nic.nhs.uk/
Advice focussing on copyright http://www.jisclegal.ac.uk/ipr/IntellectualProperty.htm
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AMRC Position Paper - Intellectual Property & Patenting in Biotechnology
The UK is a world leader in discovering and developing healthcare treatments that have benefited
millions of people. Maintaining this position depends upon the underpinning provided by high quality
biomedical research and innovation, and a legislative system that allows such innovation to be
rewarded and incentivised through the granting of intellectual property rights (IPR).
AMRC recognises the importance of IPR in maintaining a spirit of innovation but notes that a careful
balance between the needs of business, those of researchers and of patients/consumers must be
struck. AMRC is aware that the public has misgivings regarding the involvement of commercial
organizations in some areas of biomedicine – perhaps because the profit motive in medicine is seen as
being counter to public benefit. In the field of biotechnology there have also been some examples
where unnecessarily broad patents have been granted, which have had the effect of stifling or limiting
further research in an area and creating monopolies.
This statement details AMRC’s position on IPR, summarises legislation currently regulating granting of
IP in the field of biotechnology and highlights issues that charities may need to take into account in this
Position on Intellectual Property Rights
There is no single model for the management of the commercially exploitable outcomes of research
which will suit all charities and all types of research and AMRC advises charities to take a pragmatic
approach and acknowledge that each case may need to be handled differently. However, there are a
number of general principles that charities should consider in the management of IPR. AMRC therefore
In most situations charities should not seek to own IPR arising from the research that they fund.
The ownership of intellectual property rights and the way in which they will be managed and
exploited should be set out in the terms and conditions of grants and agreed between the
charity, the research institution and the researchers before the research commences.
Medical research charities are not under any duty to acquire the IPR to any research they fund
in external research institutions, provided that the research falls within the objects of the charity,
so that making of the grant constitutes the fulfilment by the trustees of the charity's objects
Shared ownership of intellectual property is rarely the most practical or desirable of options.
Therefore, where multiple funding sources are present or multiple inventors are involved, the
AMRC would recommend that charities make clear who owns the intellectual property and who
has the lead responsibility in its management.
Except in the case of academic copyright, the employer will normally own the IP arising from the
work of employees. Therefore, when charities fund research at universities, NHS Trusts or
other research institutes, the IPR arising from that work belongs to the host institution
Charities should expect research institutions to have clear guidelines for staff and students on
ownership of intellectual property and on their procedures for the identification and protection of
Charities should be aware that separate provision may need to be made to cover IP generated
by research students, visiting researchers from overseas and collaborating institutions.
Where charities have their own research institutes, they will be the employers and thus own the
IP arising from the endeavours of their staff. Such charities have responsibility for the protection
of research outcomes and for ensuring that exploitation is carried out, if appropriate
In certain circumstances the charity trustees may consider that their charitable objects would
best be pursued by making a particular research outcome or discovery freely available, whether
to commercial concerns or to the research community in general.
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Charities should have in place a mechanism for monitoring whether IP is likely to arise from the
research that it has supported.
This is not an obligation on charity trustees to actively monitor how or how effectively the
research institution exploits research outcomes but rather to be sure the research institution
complies with the charity's terms and conditions of grant.
Such a statement is not intended to mean that charities should delay or prevent publication or
commercial exploitation without good cause.
Charities are advised to state in their terms and conditions of grants that the research and the
results of the research may not be commercially exploited in any way without the prior written
agreement of the funding charity.
It is important to remember that IPRs could not have been generated without the financial support for
research activity provided by the charity and therefore the charity should share in the royalties and
other income arising from the research.
Charity trustees should be aware also that commercial priorities may lead to patents being
acquired by potential competitors in order to inhibit further commercial development of the
research. Licence agreements should make appropriate provision to ensure that the
research is developed within a stated timetable: if not, the rights to the research should be
returned to the charity or research institution.
It is rare for medical research charities to be the sole funders of research undertaken in
universities. Thus, in the terms and conditions agreed with research institutions it would be
reasonable for charities to state that royalties and other income arising from the research
should be shared in proportion to the investment made by funders, less any legal, patenting
and associated costs incurred.
Because the proportion of the charity's investment in the research relative to the overall
costs cannot always be determined in advance it will often be necessary to reach agreement
on the percentage returns due to respective funding partners once a research outcome has
been identified and a decision to commercially exploit it has been made.
AMRC would expect employers to offer individual researchers a reward if their research
leads to profitable commercial development both for patentable and non-patentable
products. Such rewards are acceptable within public bodies and can provide an incentive
for researchers. The researcher (or group of researchers) should receive a percentage from
the profits of the commercial exploitation of the research.
Legislation governing biotechnology inventions
Innovation and development in the field of biotechnology and biomedicine continues apace, and in
recent years the patenting of biotechnology inventions, including copies of human genes (replicated
outside the body) has become well established. To date, the legislation which governs granting of
patents in this area is based on the European Biotechnology Directive 1998 (Directive 98/44/EC), which
was formally adopted by the UK Government under the Patent Regulations, 2000.
In particular, it welcomes the restrictions laid out under the directive prohibiting patenting of ”the human
body, at the various stages of its formation and development, and the simple discovery of one of its
elements, including the sequence or partial sequence of a gene”.
However, AMRC recognises that the act does not prohibit patents being granted on biological material
which has been isolated from its source by a novel and inventive process; patents concerning human
genes and their sequence information, for example, if derived from a novel isolation process, are
AMRC does not feel that these provisions are likely to jeopardize the future of medical research by
restricting researchers ability to work on genes or other biological material that increasingly become the
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subject of broad-ranging patent restrictions. Indeed, patenting of human gene sequences has already
become commonplace with little major impact on medical research, and it is likely that, as the body of
knowledge accrued by the research community in this area increases, patents on gene sequences will
become restricted on the grounds that they do not pass the inventive step (see box 1).
Nevertheless, it is possible that allowing patents to be granted on gene sequences and other
biotechnological innovation related to normal biological processes could pave the way for overly
generous patents which could undermine further research and the patient benefits consequent thereon.
Recognising that the strictures in the directive are broad and relatively poorly defined, AMRC
recommends that caution should be exercised by national patent agencies in interpreting the terms of
the directive in this area: most patient groups recognise the importance of patent protection for medical
inventions, but wish to see appropriate checks and balances so that commercial interests do not gain
patents which are unreasonably broad or which cannot be used to develop healthcare benefits. On this
basis, AMRC considers the following in the field of biotechnological innovations:
The UK Government should take a lead in ensuring that the European / Worldwide patent
systems continue to operate in the public interest with respect to patents on biological
materials relating to healthcare.
The patents offices should carefully consider the existing criteria of novelty, non-
obviousness and industrial applicability for the granting of patents on DNA sequences.
Where appropriate, the patent offices should limit the scope of the protection granted to the
specific use disclosed in the patent application.
Patent offices should make public as soon as possible the improvements they are making to
the procedures for challenging patents.
The UK government should review mechanisms to limit the scope of patents already
awarded and use them if the patent system is failing to operate in the public interest.
Above all, AMRC believes that the granting of intellectual property rights should ultimately be to the
benefit of the wider UK public; fostering and encouraging innovation and research rather than stifling it.
Development and implications of patent law in the field of biotechnology and genetic
Article 16/c of the European Directive created a commission which would report to the European
Commission and Parliament on key developments in patent law in the field of biotechnology and
human genetics. In its latest report of July 14, 2007, the commission investigated the application of
patent law to partial or whole gene sequences isolated from the human body.
The principal findings of the report were that the directive gave little clear guidance as to the scope
of patents granted in this area, leading to differential interpretations among member states as to
whether or not protection on gene sequences should be limited to a specific purpose. The report
concluded, however, that issuing specific guidance on this issue would not be required, on the basis
that patenting in the area was likely to become increasingly restricted due to failure to pass the
inventive step; any new legislation was therefore unlikely to be of significant impact to actors in the
field. This is exemplified by the case of the BRCA 1 gene patent: Initially, a restrictive patent taken
out on this gene – important in the diagnosis of certain varieties of breast cancer – by the Myriad
genetics company caused considerable concern among clinicians, who would have had to send
patient samples to the company to be diagnosed, at a potentially prohibitive cost. However, the first
of three patents obtained by Myriad has now been overruled, whilst the second and third have been
severely limited in scope, on the grounds of failure to demonstrate novelty.
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AMRC Guidelines- Intellectual property: terms and conditions
These guidelines are intended to assist those charities which are developing or reviewing their terms
and condition of grant to cover the management of intellectual property arising as a result of research
they have funded in external institutions. These clauses first outline the issue that they are addressing
and then recommend a form of wording. Many charities already cover all of these points in their terms
and conditions but others may wish to review their documentation in light of this guidance. They should
be read in conjunction with the AMRC Briefing paper and Policy on IPR and Biotechnology Patents.
There is an assumption made by some that because charities fund research for public benefit that this
aim is incompatible with the protection of intellectual property (IP) and commercial exploitation.
However, there may be circumstances where a charity’s objectives can be best achieved by pursuing
Suggested wording: As a charity, ‘charity name’ is under an obligation to ensure that the useful
results of research that it funds (whether in whole or in part) are applied for the public good. In
some circumstances, this obligation may be best achieved through the protection of intellectual
property and commercial exploitation.
Notification and monitoring
In order to make decisions about the management of intellectual property, a charity needs to be
informed about the likelihood of it arising from the research it funds, as well as whether it is actually in
the process of being developed. Therefore, it is not unreasonable for charities to suggest that research
institutions have mechanisms in place for monitoring potential inventions and for notifying the funder.
Filing of a patent has implications for publishing but this is not as restrictive as many people imagine.
Many charities also require the applicant to indicate on the application form, and when reporting on the
progress of the research, whether any IP is possible or is in development. The charity should therefore
have monitoring in place to enable it to track such potential outputs.
Suggested wording. The institution and grant holders should notify ‘charity name’ promptly in
writing when IP arises from the grant and ensure that such IP is protected and not published or
otherwise disclosed publicly prior to protection (whilst at the same time ensuring that potential
delays in publication are minimised).
It is important that staff employed on the grant or who have a connection with the research should
understand their obligations to both the funder and the institution regarding the ownership and
management of IP. It is a reasonable to expect that research institutions should have clear guidelines
for staff and students on ownership of IP and on their procedures for identification and protection of it.
For most forms of IP, institutions will retain ownership but in academia the exception tends to be
ownership of academic copyright, which usually is retained by the individual.
Although students at both the undergraduate and postgraduate levels are not regarded as employees,
for the purposes of IP, many universities now require the student to sign a contract granting IP to the
Suggested wording: ‘Charity name’ requires the institution to have procedures in place for the
identification, protection, management and exploitation of ‘charity’-funded intellectual property.
Ownership and management
AMRC recommends that in most cases charity would not want to own the IP. Most intellectual property
rights belong to the employer, which in most cases is not the charity but a research institution. Shared
ownership is rarely the most practical or desirable option. Therefore, it should be made clear who owns
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the IP and who has lead responsibility in its management. However, a charity has the right to be
notified before IP is exploited or disposed of.
Suggested wording. Ensure that all persons in receipt of ‘charity name’ funding or working on a
‘charity name’ funded activity (including employees, students, visiting staff and subcontractors)
are employed or retained on terms that vest in the Institution all ‘charity name’-funded IP.
If the institution decides not to protect, manage, exploit any ‘charity name’-funded IP arising out of
the grant then the charity has a right, but not a duty’ to protect, manage or exploit such IP. If
‘charity name’ decides to exercise its right, the institution agrees and will ensure that its
employees and students and any third party, acting on its behalf does, all acts required to assist
‘charity name’ in such protection and exploitation.
Rights and revenue sharing
It is important that a charity’s right to IP and to income generated from it are fully protected in situations
where there is more that one funding agency, whose terms and conditions on funding may differ from
those of the charity.
Suggested wording. The institution, grant holders and co-applicants should confirm upon
acceptance of the grant that there are no pre-existing arrangements which have not been
disclosed fully in writing to charity name which are or could lead to a breach of the charity name-
funded standard conditions. The institution should ensure that no consultancies, third party
restrictions or arrangements are entered into in relation to any ‘charity name’-funded person or
activity without prior agreement of the charity. Charity-funded investigators or individuals involved
in a charity-funded project should not use materials or compounds (other than those obtained
commercially), on terms which would place restrictions on the publication of the results.
Institutions should ensure that ‘reach through rights’ have not been granted on any charity-funded
IP in favour of commercial organisations providing materials or compounds to charity-funded
individuals for research purposes.
If the host institution has used its staff and facilities to identify, verify, protect and begin exploitation of
IP, then, it is not unreasonable that they receive compensation for the work done. However, research
institutions should not neglect the other parties (including the funders and the inventors) that made the
invention possible. It should be remembered that IP could not have been generated without the
financial support for the research activity provided by the charity and therefore the charity should share
in the royalties and other income arising from the exploitation of the research. It must be remembered
that an individual funder may often not be the sole funder of research undertaken in universities. If
there are other contributors, it is reasonable to state that royalties and other income arising from the
research should be shared in proportion to the investment made by funders, less any legal, patenting
and associated costs incurred. The proportional investment can only be estimated on the basis of
detailed financial reports and at a stage when the overall costs are known and a decision to
commercially exploit the product has been taken. However, upon giving consent to exploit the
research, charities should ensure that one of the conditions should be that the institution accepts the
charity’s terms for revenue and equity sharing.
Suggested wording: As a condition of granting consent, charity name will require the institution
to accept standard revenue and equity sharing terms of the charity. (Charities may wish to
append this statement to suggested wording under Pt.4)
The different components that need to be considered in any revenue sharing agreement include:
Direct costs of exploitation: these include initial patent filings, legal costs, travel and other items
associated with the verification and granting of IPR. This type of cost is rarely covered in a grant.
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Technology transfer fee: these are the costs associated with the host institution’s office of technology
transfer. Most universities seek to charge 30% of net revenue to cover these costs.
Institutional share/inventor share: policies on ‘inventor share’ vary but on average a proportion
between 20-30% is the norm for UK universities, with a larger share going to the inventor when the
revenue is lower.
Funder(s) share: this will vary depending upon whether the funder has been identified as the sole
funder of the research or whether it was one of several funders. In the case of being the sole funder
the share may need to be reflect the overall contribution that the charity has made. In the case of
multiple funders the share will reflect their relative contributions.
The exact proportions assigned in any revenue sharing scheme may need to be negotiated on a case-
by-case basis and will also vary depending upon the amount of revenue generated. For example, there
is usually a sliding scale of distribution depending upon the income generated. The following examples
are provided as a framework upon which to base negotiations and charities may wish to vary these
according to the circumstances of each case.
It should be anticipated that any research organisation that has been responsible for the exploitation
should deduct the direct costs that have been incurred as a result of the exploitation. Further, the
organisation is entitled to receive a technology transfer fee on the net income received. But AMRC has
not been persuaded by the argument by some universities that they automatically should be able to
topslice 30% and more of revenue, especially given the variable nature of both technology transfer
costs and the institutional expertise in this area. Typical percentages for the technology transfer fee
should also be on a sliding scale and the following percentages are recommended:
Cumulative income (£) TT fee
Up to 100k 30%
100 – 500k 25%
More than 500k 20%
The remaining net income is then distributed between the institution and the funder. This split may vary
but if the charity is the sole funder, the institutional:funder share is of the order of 65:35 or 60:40
depending upon cumulative income.
If the charity is not the sole funder it is the responsibility of the institution to identify the inventive
contribution of the inventors and the proportionate funding contributions of the funders. It is also the
responsibility of the institution to reward inventors of IP from the revenue share according to its own
policies and practice. Similarly, the institution and its technology transfer company should agree how to
share between themselves any technology transfer fees or shares of net income and/or equity due to
either or both of them.
AMRC hopes that by setting out explicitly how technology transfer costs can be met, the model
framework will encourage the most appropriate body to take the lead. In addition to using the model
agreement, it is recommended the charities seek the following undertakings from research institutions:
an annual exploitation report
annual accounting statements / payments
copies of all agreements with commercial or other partners regarding exploitation
6 monthly update meetings
Equity shares: It is recommended that proportionate shareholdings are issued direct to the parties
involved, unless otherwise agreed.
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