R&D projects for HIV/Aids

There’s a great deal of sophistication in the way pharmaceutical companies are getting products to disadvantaged areas while addressing global health priorities. However, good practice is limited to a narrow range of products and countries, and opportunities to expand efforts are yet to be realised.

The 2016 Access to Medicine Index, published in November 2016, ranks the top 20 pharmaceutical companies on their efforts to improve access to medicine in low-and middle-income countries. It found that GSK, which leads the Index for the fifth time, performs best at matching its access activities with particular needs within the access-to-medicine agenda.

GSK is joined at the top of the Index by a closely packed group consisting of Johnson & Johnson, Novartis and Merck.

The companies featured in the Index have 850 products on the market for the 51 most burdensome diseases in low-and middle-income countries, and are developing another 420. This includes more than 100 products that entered the pipeline since 2014, and 151 with low commercial incentive but which are urgently needed by the poor.

‘We see evidence that collaborative R&D models are engaging the industry in developing urgently needed medicines they would not otherwise be considering because there is not enough commercial incentive,’ says Jayasree Iyer, executive director of the Access to Medicine Foundation. ‘The partnership approach is working.’

Voluntary licencing and collaborative R&D

Progress in making more medicines more available is also seen in the ways companies are handling patents and the extent to which they allow other manufacturers to make generic versions of their products.

Since 2014, seven companies have published or expanded pledges to waive or abandon patent rights for certain products in certain regions. More HIV/Aids products are covered by voluntary licences, which apply in more countries than before.

The 20 pharmaceutical companies analysed in the Index are working on 32 R&D projects for HIV/Aids, including 23 that address high-priority product gaps. These gaps are for urgently needed new products – such as preventive vaccines, or medicines intended for use in poor countries – and offer low commercial incentive for companies to engage in product development. These 23 projects are being developed by eight companies.

ViiV Healthcare (joint venture between GSK and Pfizer) is developing child-sized versions of three HIV/Aids products: maraviroc, dolutegravir (with the IMPAACT Network) and a fixeddose combination of dolutegravir/ abacavir/lamivudine. These three projects are all in phase III.

GSK and Sanofi are collaborating with others via the P5 platform (Pox-Protein public-private partnership) to develop an HIV vaccine. A phase III trial in South Africa has begun.

A decade of assessments

The diseases getting the most attention from company access activities are heart disease, lower respiratory infections and HIV/Aids. R&D is still concentrated on five diseases, with lower respiratory infections getting the most focus, followed by diabetes, malaria, viral hepatitis and HIV/Aids.

Most companies are also working to strengthen healthcare systems in low- and middle-income countries. Six consistently match these activities to priorities identified by local parties, including governments.

‘We have been assessing these 20 companies for 10 years now. We know what works, where. There is good practice and where there are mechanisms to incentivise industry engagement, such as patent pooling, collaborative R&D models, multi-stakeholder initiatives and international commitments to certain diseases, we see the industry responding,’ comments Iyer. ‘Access to medicine is a collective responsibility and all stakeholders – from the industry to governments and the global health community – need to challenge themselves to support the ramping up of these efforts to ensure they are expanded to more products in more countries, so that pharmaceutical products reach the people who need them.’

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