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					    Open Access/
 Access to Medicines

      Richard Seabrook
      Joanna Shepherd

Business Development and Legal
      Technology Transfer
        Wellcome Trust
   Wellcome Trust
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)
Research Pathway

Data        Results     Knowledge

       Transformation     Impact
Access Policy

         Key Factors

         • How Transform

         • How Knowledge
         has Impact
   Access at what stage?

Data     Results      Knowledge
Open Access To Data

Genome Projects
Data Release Policy

•   Full disclosure
•   Immediate / Rapid
•   Anonymous
•   Trace repository
Genome Projects

Transformation to outcomes

•   Low cost investment
•   Many applications
•   Research currently
•   Industry long term
•   Low information content
Genome Projects


• Controls the Field
• High initially in research
   – changed biological research
• Health impact long term
• Easy access stimulates
Genome Projects


•   Human Genome Project
•   SNP Consortium
•   Hapmap Consortium
•   Industry Led Asia Cancer
    Research Group (Lilly, Merck,
Access to Results

Non-exclusive License
• 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
Exclusive Access

         • Transformation needs
         major investment

         • Impact not field controlling

         • BUT:-
  Exclusive Access

• Reversion
• Protection for academic access
• Public health access (access to
      Access to Medicines

           Joanna Shepherd

       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
Underlying issues:
•   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.

What is:

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
      for profit.
Contractual approaches:

(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
                Other considerations:

• 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
under TRIPS?

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
  developing countries.
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.

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