Increasing Access to Generic Medicines, Both Current and Future

A statement by the Medicines Patent Pool Executive Director, Greg Perry, at a briefing hosted by the WHO Department of Essential Medicines on the occasion of the World Health Assembly

22 MAY 2013: The MPP welcomes this opportunity at the time of the 66th WHA to highlight its role in assisting access and innovation in area of HIV, as well as the importance we place on WHO pre qualification.

The Medicines Patent Pool aims to advance innovation, access and public health through licensing of critical HIV medicines patents. This licensing is then used to incentivise the development of needed new medicines, such as fixed dose combinations and formulations to treat children, and to increase access to affordable versions of innovative, patented drugs.

The MPP’s mandate to assist access to affordable, adapted HIV medicines through generic competition – both through facilitating the work of existing generic players and aiding new entrants to the HIV medicines market – was given in light of changing international intellectual property rules. These rules introduced product patents on HIV medicines, including in countries that had previously been key suppliers of low-cost treatment in developing countries.

To fulfill this mandate, the MPP therefore seeks to create public health oriented licences to stimulate generic competition.  To date the MPP has agreements with three licensees – the most recent focusing on the treatment of paediatric HIV, reflecting one of the MPP’s key priorities – and currently sublicences to five generic manufactures.

The MPP offers an innovative business model with a public health focus and works constructively in cooperation with patent holders.

The voluntary licences negotiated between the MPP and patent holders are intended to maximise access to medicines through elements such as transparency, geographic scope covering as many developing countries as possible, and ensuring that flexibilities in international intellectual property rules are maintained. Patent holders in turn can benefit from both royalties and a streamlined process for licensing their patented medicines for use in developing countries, where the human need is great but the market small.

The Access to Medicines Index in 2012 called the Medicines Patent Pool “the best hope for ensuring sustained access to new first-line treatments for the disease that may be able to counter rising resistance to existing anti-retroviral drugs.”

Assuring that medicines made under MPP sublicences are quality, safe and effective, is essential to the MPP’s public health mission. As a matter of principle, the MPP insists its licensees receive quality assurance from WHO-PQ or a similarly stringent regulatory authority.  All generic companies currently working with MPP have WHO-PQ. MPP also operates a sublicencing management system that regularly reviews sublicensee activity, in order to ensure they are meeting the quality and guarantee of access standards set by the MPP.

MPP also supports moves that speed regulatory approval of quality medicines in national markets.

Developing country initiatives to grant automatic or fast track registration of WHO prequalified products is essential, as no day should be wasted in getting life saving treatments to people living with HIV. With this mind the MPP supports the WHO’s special collaborative procedure that enables collaboration between the WHO-PQ and national drug regulators to speed drug registration.

As a public health entity, MPP’s collaboration with WHO is broad. The MPP’s list of priority antiretrovirals for inclusion in its licences is based on guidelines and advice from WHO. The MPP welcomes WHO Director General Margaret Chan expressed support for the MPP and her admiration for the companies in negotiations with the MPP.

Through partnership with the WHO, industry, and the communities of people living with HIV, the MPP will work to bridge the link between innovation and access in the field of HIV.

Greg Perry’s presentation from this meeting is available here.

The MPP and the WHO-PQ have formalised their collaboration on this essential work in a document available here.

The WHO’s HIV/AIDS Strategy for 2011-2015 is available here.

This page is also available in: French, Spanish