British government endorses patent pool for developing world HIV drugs

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A patent pool for HIV drugs was endorsed on Monday by Michael Foster, Parliamentary Under-Secretary of State at the Department for International Development (DfID), the British government minister responsible for the UK's global AIDS policy.

Britain’s All-Party Parliamentary Group on AIDS also endorses the patent pool proposal in a new report, The treatment timebomb, published this week.

Glossary

first-line therapy

The regimen used when starting treatment for the first time.

second-line treatment

The second preferred therapy for a particular condition, used after first-line treatment fails or if a person cannot tolerate first-line drugs.

"The pharmaceutical industry has an opportunity to act now to help prevent future human catastrophe. It is time for them to state their clear commitment to make new HIV medicines affordable to those who need them most," Foster told The Guardian newspaper on Monday.

The patent pool is being proposed by UNITAID, the fund set up by governments including Britain and France to finance the purchase of antiretroviral drugs for the developing countries worst hit by HIV.

UNITAID would like to see manufacturers hand over the management of patents to a patent pool which would set standard terms for voluntary licensing and royalty payments in the developing world. The patent pool would encourage manufacturers in the developing world to seek licences, in the hope that promoting competition within a managed environment in which drug purchases are predictable over a number of years will drive down prices, particularly of second-line drugs.

Major pharmaceutical companies have been lukewarm about the idea in public, but some are privately interested because the patent pool may relieve them of the need to manage voluntary licensing and access schemes.

However Glaxo SmithKline chief executive, Andrew Witty, told journalists in a conference call on Monday that "up until now I've not really seen the articulation of how a patent pool in this particular area would change things dramatically," according to Reuters.

Glaxo SmithKline announced earlier this year that it was putting its patents for drugs to treat negleceted diseases into a patent pool to encourage research and development.

"The patent pool on neglected diseases was because there was really no research going on in that area – HIV is not a neglected disease," he said.

The All-Party Parliamentary Group on AIDS endorsement of the patent pool proprosal comes after a six-month enquiry by the group, which represents British parliamentarians of all parties who are concerned about AIDS. Members of parliament heard evidence from more than 30 organisations, including the World Health Organization, pharmaceutical companies and development organisations.

The report also recommends that developed world governments need to commit to long-term planning for the AIDS response, beyond 2015, and should provide long-term assurances to purchasers of HIV medicines, such as the Global Fund, UNITAID and PEPFAR, that funds will be available to buy drugs.

Other key recommendations include:

  • Urgent action needs to be taken to reduce the cost of the WHO-recommended first-line alternative to the basic d4T+3TC+NVP combination, to enable the treatment of those who cannot tolerate stavudine, and donors need to commit to funding alternative drugs even if they are more costly. WHO should promote its recommendations about dropping stavudine wherever possible more clearly to national governments.
  • There should be an independent analysis of the relative costs and benefits of different types of pharmaceutical access programmes. DFID would be well-placed to conduct this. Pharmaceutical companies should open up their access programmes to independent audit to increase confidence in them.
  • WIPO [the World Intellectual Property Organization] should be held accountable to its development agenda, and asked to demonstrate examples of supporting developing countries to use their TRIPS [Trade-Related Aspects of Intellectual Property Rights Agreement] flexibilities to protect public health.
  • The UK Government should use its influence at the European Commission, particularly given the EC Trade Commissioner post is held by the British, to halt the adoption of TRIPS+ clauses in trade agreements that limit the ability of developing country governments to protect public health and use TRIPS flexibilities to reduce the costs of medicines.
  • DFID, in communication with its counterparts from other donor countries and with UNITAID, should look into the workability of a prize fund for key missing medicines and diagnostics. Other proposals to stimulate R&D need to ensure adequate financial incentives to the private sector.