New medicines, vaccines and diagnostics are needed to tackle the life-threatening and debilitating diseases suffered by people in low income countries, and to improve their health. Products are being developed by the Product Development Partnerships (PDPs), who have as part of their core missions the requirement to make them appropriate, acceptable, affordable and available for use in low income settings. Ensuring access to these products, so that they reach those who need them most, is a significant challenge which must be considered early on in product development.

PDPs and donors are actively involved in identifying key components for the development of effective access strategies. To this end, the PDP Access Steering Committee commissioned a series of discussion papers and convened a meeting of PDPs, donors, international organizations, global health partnerships, endemic country programs and implementing organizations in July 2010 to advance the discussions in 5 main areas: access strategies; country decision-making; regulatory issues; pricing; and economics and financing.

The goal was to improve performance, efficiency and use of resources of PDP access teams using the expertise available across the PDPs and from other global health partners, in support of the PDPs?overall goal of improving health outcomes. The specific objectives of the meeting were to:

• Share preliminary conclusions regarding strategies and their rationales, arising from the draft discussion papers on the 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. From the donor perspective the need is for sustainable funding to develop and disseminate the products, to optimise impact and to identify the funding gaps. The donor community expects PDPs to develop strategies to mobilise additional 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. However, PDPs may need to play a role in identifying gaps and solutions, as well as coordinating the activities needed to enable low income countries to take the decision to adopt a product. Highlights from the discussion centered on the relative absence of access metrics measuring progress before the launch of the product, the potential of a PDP seal of approval to promote a range of products under a single umbrella brand, the need to more clearly communicate the limits of delivery by PDP access teams, the evolution of access strategies as the product comes to market, and the role that the PDP’s relationships with its commercial partners in developing the products plays in ensuring access.

In Session 3 the role of the PDPs in facilitating country decision-making was addressed. Possible contributions of and relationships with the government, multilaterals such as WHO, local researchers and professional organisations, NGOs, and the manufacturing partners were discussed. 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. Discussion also raised the following points:

• While countries usually want to adopt a product that will improve public health, there may not be sufficient financial and administrative capacity. Establishing a decision-making framework can guide stakeholders through the process of introduction.
• It is important to encourage the creation of an appropriate structure in-country, such as an advisory committee, as the forum for technical and programme management discussions.
• 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 (e.g. NGOs, district administration etc) 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. A range of pricing models and practices were presented from the demand and supply side perspectives such as might be considered by commercial manufacturers, PDPs, countries and donors. In discussion the following points emerged:

• The price needs to be sufficient to encourage manufacturers to take the risks inherent in a new product.
• Cost plus, target pricing, health outcome based, pure market and segmented pricing were discussed as possible approaches, sometimes in combination.

Session 6 addressed the economic and financing 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 Steering Committee. The proposals included:

• documentation, analysis and costing of access
• 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.