Access to Medicines
Business Development and Legal
Three Focus Areas
• Supporting outstanding
• Accelerating the
application of research
• Exploring medicine in
historical and cultural
Technology Transfer global • Typhoid multivalent vaccine (Italy)
• H5N1 antibodies (USA, Switzerland)
activities • STD diagnostics (UK, USA)
• Emergency fever therapy (Thailand, UK)
• NITD (Singapore, USA, Holland)
• Dengue drug discovery (Belgium)
• Oral pandemic flu vaccine (USA)
• Antibiotic drug discovery x 2 (USA)
• Sandfly trap (UK, Brazil)
• TB diagnostics (UK, Malawi)
• TB vaccine (UK, USA, S Africa)
• Typhoid oral vaccine (USA Vietnam)
Data Results Knowledge
• How Transform
• How Knowledge
Access at what stage?
Data Results Knowledge
Open Access To Data
Data Release Policy
• Full disclosure
• Immediate / Rapid
• Trace repository
Transformation to outcomes
• Low cost investment
• Many applications
• Research currently
• Industry long term
• Low information content
• Controls the Field
• High initially in research
– changed biological research
• Health impact long term
• Easy access stimulates
• Human Genome Project
• SNP Consortium
• Hapmap Consortium
• Industry Led Asia Cancer
Research Group (Lilly, Merck,
Access to Results
• Cohen-Boyer Patent
• USA only
• Stanford Non-Ex Strategy
Cohen – Boyer cont
Transformation – low
Major Impact – tool that
controls the field
Cohen – Boyer cont
Reported Outcomes from
Non –Exclusive Strategy
• 468 companies licensed
• Founded Genentech
• Founded USA Biotech Industry
• Multiple Healthcare Products
• Transformation needs
• Impact not field controlling
• Protection for academic access
• Public health access (access to
Access to Medicines
Legal and Operations Adviser
Technology Transfer Division, Wellcome Trust
• What is “access to medicines”?
– Ensuring access to affordable medicines in developing
– Also known as humanitarian licensing or global social
• Why should we consider access to medicines?
– Universities and research institutions play a critical role
in medical innovation and should use their clout to help
make lifesaving medicines more affordable to poorer
• Access Gap - poor people in poor countries do not have
access to certain medicines and vaccines.
– According to WHO roughly 10 million lives could be saved
annually by improving access to essential medicines.
– Approx. 30% of the world’s population do not have regular
access to essential medicines, rising to 50% in the poorest
parts of Africa and Asia.
– In developing countries typically 50 to 95% of medicines are
paid for by patients themselves.
• R&D Gap -
– Only 10% of the world’s expenditure on R&D is devoted to
conditions that cause 90% of the global disease burden.
– Current R&D system fails to optimize existing medicines and
medical technologies for use in developing countries.
– It is not necessarily in a pharmaceutical company’s interest
to agree to supply or licence others to supply medicines at
affordable prices in developing countries.
– Patents may obstruct production and export from certain
• How can we address access to medicines?
– Accepted approach is the introduction of two tier
pricing for patent protected drugs.
– Drugs can be sold at generic prices in developing
countries during their period of patent exclusivity and
high prices in developed countries.
A “poor country”?
- Issue: in some developing countries there is co-
existence of the for-profit market and the at cost
market (i.e. charity/NGO funded).
An “affordable price”?
- No simple answer.
- Most common method for defining affordability -
direct costs of manufacture plus a modest mark-up
(1) Development milestones
(2) Mandatory delivery in developing countries
(3) Control over pricing in developing countries
(4) Compulsory sublicensing
(5) Step-in rights
(6) Due exploitation
(7) Express acknowledgement that licensee’s rights subject to
any compulsory licences
• Obligation on the licensee to cooperate and negotiate in
good faith with the university/research institution and any
prospective licensee who may request a voluntary licence
for a developing country.
• Waive right to receive royalties in the developing world.
• Consider requirement for public sector involvement in
developing countries to ensure quality control.
Why not simply rely on compulsory licensing
Limitations to compulsory licensing under TRIPS:
TRIPS specifies conditions which must be imposed by
governments when issuing compulsory licences. These include:
– Case by case decisions
– Must seek voluntary licence first (except in cases of public
non-commercial use, extreme urgency and national
– Adequate remuneration to the patent holder (not defined)
– Compulsory licences must be non-exclusive and non-
Note: less stringent conditions apply in the case of government
Limitations to TRIPS flexibilities:
- Conditions make the process cumbersome and
- Safeguards in TRIPS can only be used once they
have been incorporated into national law.
- Case by case decisions require administrative
capacity to take consistent, rapid action whenever
patents pose pricing barriers.
- Pressure from developed country governments to
remove/reduce TRIPS flexibilities and ensure data
Charitable law issues:
• Most universities in the UK as charities and as such must
pursue the charitable objects laid down in their constitution.
• Charitable objects are likely to focus on the advancement of
• In practice, as long as any activities outside of the scope of the
charitable objects are minor compared with the primary
charitable objectives, it is unlikely that the UK Charity
Commissioners will intervene.
• Recommendation: consult constitutional documents and take
legal advice on current charity law.
• Lost revenue from developing countries – minimal as developing
countries typically represent only a few per cent of those few per
cent of total revenues that pharmaceutical companies make in
How can Universities/Research Institutions help?
• Make socially responsible licensing a formal, stated
institutional policy and reference the concept in any
licensing term sheets.
• Re-evaluate success measures for technology transfer to
include the impact on global human welfare.
• Avoid inadvertent granting of exclusive licences without
building in protections for developing-country needs.