Consultative expert working group - proposals

1. Consultative expert working group - proposals Barcelona 04.10.2011

2. Four proposals for innovative financing • A new indirect tax • Voluntary contributions from businesses and consumers • Taxation of repatriated pharmaceutical industry profits • New donor funds for health research and development

3. Further proposals sought • Open forum during the first meeting of the CEWG • Submissions received in response to the CEWG's call for submission of proposals • Overview of assessment which were included in July meeting for further analysis with some explanation what the mechanisms could imply

4. Intellectual property rights management Equitable Licensing Open source Removal of data exclusivity Transferable intellectual property rights Patent pools (UNITAID model) Green intellectual property Public financing Direct grants to small companies and for trials in developing countries Prizes, milestone and end Pooled funds-related proposals Precompetitive research and development platforms Health impact fund Neglected disease tax breaks for companies Marketing approval Orphan drug legislation Priority review voucher Regulatory harmonization Global more complex issues Coordination mechanisms Biomedical research and development treaty

5. Proposals 1 • Open source • Collaborators forgo patents as outputs are based on public domain allowing collaboration through open access research sites • Equitable licensing • Research and development financing licensing terms allow for access to products, data or R&D

6. Proposals 2 • Green intellectual property • The proposal for Green Intellectual Property proposes in principle to introduce charges for patenting and a 10% premium for profits gained from patents so as to fund access to products and support R&D • Removal/use of data exclusivity • Data exclusivity means that for a period of several years from the date an originator non-biological product is approved for marketing, no other company may seek regulatory approval of an equivalent product based on data submitted by the originator company without the latter’s approval. • The effect of data exclusivity is to prevent, for a period of time, the entry of generic competition, even if the originator product is not protected by a valid patent.

7. Proposals 3 • Transferable intellectual property rights • The idea is that a reward would be offered to companies which developed a product to fight neglected diseases in the form of an extension of market exclusivity which could be used on another top selling product. • TIPR will work by extending market exclusivity for top selling products in developed country markets. • Patent pools - UNITAID model • Its objectives are to accelerate availability of new generic ARVs in developing countries, stimulate R&D where patents are owned by different holders and facilitate adapted formulations of medicines (e.g. children). These objectives are tackled through pooling different related patents that the patent holders supply voluntarily to the Pool. Developing countries based manufacturers may obtain a license of any patent in the pool against negotiated royalties and use it to develop new or produce cheaper products.

8. Proposals 4 • Pooled funding and PDPs • Funds in support of product development partnerships • Importance of how organised, IPR managed • Grants • Direct grants to small and medium sized entreprises for R&D to bring a potential new medicine through Phase 1 trials, at which stage it may be possible to attract commercial funding in one form or another

9. Proposal 5 • Prizes (end and milestone) • There are basically two kind of prizes – for reaching specified milestones in the R&D process, or for reaching a specified endpoint such as a new diagnostic, vaccine or medicine with a specified profile in terms of performance, cost, efficacy and/or other important characteristics. • Purchase or procurement agreements • Purchase or procurement agreements are contracts between a purchaser, normally a government or an international financing agency, and suppliers which involve some form of guarantee as regards price and/or volume, includes Advance Market Commitments (AMCs).

10. Proposals 6 • Neglected disease tax breaks for companies • This proposal is a provision in tax laws allowing companies to set expenditures on R & D for neglected diseases against their tax liabilities. • Health impact fund • Firms may register a product to HIF. By registering, a firm agrees to provide its medicine at a price near the cost of production anywhere it is needed. In exchange, they will be paid by the Fund annually for ten years based on the HIF’s assessment of the actual health impact (quality adjusted life-years gained) of the medicine.

11. Proposals 7 • Orphan drug legislation • An orphan drug is a pharmaceutical product that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. • In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as financial support to R&D and extended exclusivity periods • Priority review voucher • In the US scheme, those who obtain marketing approval from the Food and Drug Administration (FDA) for a product to treat or prevent one of 16 neglected tropical diseases are entitled to receive a priority review voucher (PRV) which entitles the bearer to receive priority review of another product that would not otherwise qualify for priority review. • By this means a company could advance the approval of a potentially “blockbuster” product with correspondingly increased revenues

12. Proposal 8 • Precompetitive platforms • Support to precompetitive R&D open to various stakeholders, different forms and levels of engagement • Regulatory harmonization • Proposal is based on implied benefits from shorter regulatory approval times and aligning requirements of developing countries for regulatory approval

13. Research proposal 9 • Biomedical R&D Treaty • Different levels of ambition from framework type of measures and strenghtening normative committments to more comprehensive global delinking R&D from prices of products (earlier specific proposals on R&D Treaty) • Coordination • Coordination on R&D priority setting • Coordination on information sharing (open source and precompetitive for R&D), capacity building and technology transfer • Coordination in tracking and evaluating investments related to R&D and innovation • the role and capacities of WHO in this process

14. EWG PROPOSALS + • Funding allocation • product development partnerships • direct grants to companies and trials in developing countries • prizes • purchase of procurement agreements • Efficiency • precompetitive R&D platforms • regulatory harmonisation