PDP Access Steering Committee

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Steering Committee Meetings

2010/Geneva

After the PDP Access Group had commissioned an initial set of five discussion papers (on access strategies, country decision making, regulatory strategy, pricing, and economics and financing), a second dedicated, face-to-face meeting was organized in July 2010:

At this second meeting, we were also joined by representatives from endemic countries, donors, the WHO and implementing organizations, who all contributed useful perspectives. The meeting was supported by the Concept Foundation with funding from the Rockefeller Foundation.

The specific objectives of the meeting were to:

  • Share preliminary conclusions regarding strategies and their rationales, arising from the draft discussion papers on 5 topics.
  • Determine the implications of these conclusions for PDPs and their access work, taking account of the case studies presented at the meeting.
  • Agree on next steps to build upon the shared experiences and identify areas for further investigation, collaboration and implementation.

Session 1 set the scene by identifying the issues of access to new products seen from the point of view of recipient countries and the donor community. Countries are concerned about the availability of financing required to buy a product and to make it widely available at an affordable price for as long as needed. They need to consider regulation, the economic case, the health impact and integration with existing health programmes. The donor community expects PDPs to develop strategies to mobilise additional, sustainable resources, increase cost effectiveness through collaboration, and identify implementing partners who can support access.

In Session 2 participants reviewed the discussion paper on Access Strategy. PDPs see themselves as catalysts, not implementing agencies; in most cases they do not directly implement programmes to provide access to their products but identify gaps and solutions. Highlights from the discussion centered on the relative absence of access metrics measuring progress before the launch of the product, the need to more clearly communicate the limits of delivery by PDP access teams, and the evolution of access strategies as the product comes to market.

In Session 3 the role of the PDPs in facilitating country decision-making was addressed. Discussion centered around the possible contributions of and relationships with the government, multilaterals such as WHO, local researchers, professional organisations, NGOs, and manufacturing partners. Although PDPs may be concerned about the impact of their product, the country is interested in how it fits into the public health package as a whole, and the strategies adopted need to reflect this reality. PDPs need to be flexible in choosing partners – a research institution may be the most important partner at the beginning, but later a range of implementers will need to be engaged.

Session 4 discussed the regulatory challenges in ensuring equitable access to new health products in low income countries. Regional and national perspectives and the regulatory processes of WHO were reviewed, noting that capacity to regulate the increasing number and variety of products needs to be greatly increased and streamlined. In Africa and South East Asia there are efforts to harmonise procedures and build capacity; one PDP has gone through harmonized clinical trial approval and another is submitting a drug regulatory approval on a regional basis. While WHO has well-established pre-qualification procedures they are currently over-stretched by the volume of new products being presented.

Pricing was addressed in Session 5. The appropriate pricing strategy may be different in the public and the private sector, in areas with high or low endemic disease burden, or in countries with different income levels or different funders. Possible approaches, sometimes in combination, include cost plus, target pricing, health outcome based, pure market and segmented pricing; these were presented from both the demand and supply side perspectives. Whatever approach is taken, price needs to be sufficient to encourage manufacturers to take the risks inherent in a new product.

Session 6 addressed the economic and financing {PDF} issues around the introduction of new PDP products. It was acknowledged that the economic case for the introduction of a new product, and the associated financing, tended not to be addressed early enough. PDPs could consider conducting cost-effectiveness analyses and entering into financing discussions with donors.

In the final session, participants considered the next steps to be taken by the PDP Access Group. The proposals included:

  • documentation and costing of access activities
  • development of metrics for access
  • improving availability of information (e.g. repository of resources, establishment of a website)
  • joint research or implementation projects
  • further analysis and discussion of specific access topics.

Download Presentations from the Meeting

1. Mbewu – Access in country context.pdf

2. Camus Bablon – Developing and appropriate Access Strategy.pdf

3. Atkinson – Defining success on access & metrics to track progress.pdf

4. Douglas – Branding, Advantages and Disadvantages.pdf

5. Brooke – Key drivers for optimized success.pdf

6. Gardiner – The PDP reach.pdf

7. Jagoe – MMV Access Strategy.pdf

8. Wells – Country Dmaking PDP Mtg.pdf

9. Anum – Country decision Making.pdf

10. Camus Bablon – PDP_Access DNDi approach.pdf

11. Privor Dumm – PDP work with mulitlaterals.pdf

12. Brennan – PDP reg sess July 2010.pdf

13. Sigonda – Regulatory Challenges African Context.pdf

14. Chawanon – Drug Registration Thailand.pdf

15. Meek – comparison of PQ programs.pdf

16. Guzman – Registering new drugs the African context.pdf

17. Lee – Pricing as a strategic element of an access.pdf

18. Yadav – PDP pricing.pdf

19. Chinery – A reproductive Health example.pdf

20. Privor Dumm – Economics and Financing Panel.pdf

21. McLean – Some Caveats on Cost Effectiveness.pdf

22. Guzman – PDPs what are the challenges ahead.pdf