E-DRUG: Response to Questions & Comments on Medicines Patent Pool-Gilead Licence
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We have read with great interest the large number of comments received, and/or circulated on list-servs on the recent licences between the Medicines Patent Pool and Gilead from various organizations, including communities of people living with HIV.
The licences allow for the production of the HIV medicines tenofovir, emtricitabine, cobicistat, and elvitegravir as well as a combination of these products in a single pill, known as the “Quad.” Details on the licences, as well as the ful text of the agreement itself, are available on the Medicines Patent pool website at: www.medicinespatentpool.org<http://www.medicinespatentpool.org>.
Published commentaries have reflected different perspectives on the licences. Some groups have welcomed the improvements over current voluntary licensing practices. Many have also focused on the shortcomings of the licences, most of which were identified in the Pool’s Questions and Answers that accompanied the announcement of the licenses. Others have looked at the options that are available to countries to obtain access to affordable HIV medicines, in light of the agreement. We share the concerns expressed by many groups and agree that there is room for improvement. And we are committed to working with civil society groups to continue to advocate for access-friendly licensing as a key mechanism to remove barriers to access, promote generic competition and make HIV medicines more affordable.
We believe it is important to mention the context in which the Medicines Patent Pool operates and its mandate in order to place discussions on the licences in perspective. The Medicines Patent Pool negotiates voluntary licences with patent holders aiming to create the largest possible benefits for the largest number of people. It is, however, not in a position to dictate terms and conditions to the licensors. In its exchanges with patent holders, the Pool regularly makes the case for removing restrictions from licences, for including all low- and middle-income countries, for enhanced transparency and for ensuring that public health considerations guide the formulation of terms and conditions of the licences.
In this first set of licences with a pharmaceutical company, it has been possible to make significant improvements on previous licensing practices in some key areas. These include, for example:
- the partial expansion of geographical scope, beyond that of any other licence for HIV medicines to date (actual coverage ranges between 87.6% of people living with HIV in low- and middle-income countries for tenofovir to 82.7% for elvitegravir);
- the inclusion of late-stage pipeline products so that the development of generic versions can begin immediately upon approval by the necessary regulatory authorities;
- the expansion of the field of use for tenofovir to hepatitis B;
- special provisions for paediatric formulations that waive royalties and enable sales beyond the territory of the licence;
- provisions that allow licensees to supply countries that make use of key TRIPS flexibilities, such as the issuance of compulsory licences;
- provisions enabling licensees to terminate the license unilaterally at any point in time for any reason;
- the right of licensees to pick and choose the products for which it wants a license (unbundling);
- explicit waiver of any data exclusivity rights by Gilead and future licensees; and
- the transfer of know-how without strings attached (inclusion of know-how transfer often results in no termination provisions, which is not the case in these licences).
Another key improvement has been the publication, on the Pool’s website, of the detailed terms and conditions of the licences. This is considered to be almost unprecedented in the pharmaceutical field for a licence involving a commercial company, as voluntary licences are generally kept confidential. This has even been the case for licences on HIV medicines issued or obtained by public organizations (a key exception is the NIH licence with the Pool, which is also publicly available).
Making the licences public has sparked significant debate on the optimal terms and conditions of voluntary licences. We welcome this debate. It builds upon extensive input received from many groups while establishing the Pool and regular ongoing dialogues with a wide range of stakeholders and civil society groups. It will help to keep the areas of greatest priority to the public health community in the forefront of negotiations, and create focus on where the Pool shouldcontinue to work to improve on existing licensing practices. It will also help to ensure that the present licences represent a floor and not a ceiling for future licences.
We are also aware, however, that it has not been possible for the time being to remove some restrictions. These include, in particular, the exclusion of certain countries from the geographical scope of the licences, the restrictions on the sourcing of API and the restrictions on the country of manufacture. In at least these key areas, we must continue working together to ensure that better terms and conditions can be obtained in the future.
This is why it is important to bear in mind that in addition to the Pool, other complementarymechanisms will continue to play a central role in enhancing access. The Medicines Patent Pool must be viewed in the context of the range of different policy options available to governments and other actors to promote access to HIV medicines. On its own, the Pool will not be able to remove all barriers to access. It can make a key difference in some areas and ensure that its licences do not hinder the implementation of other important access mechanisms.
We are grateful to organisations that have long been advocating for patent holders to licence to the Pool and recognize that their support has been key in obtaining the gains that have been achieved so far. Advocating now for greater inclusion and less restrictions in the Pool licences is important and we welcome the comments, suggestions and concerns expressed by a wide range of stakeholders.
We are pleased that out of 10 patent holders targeted by the Pool, 7 have entered into formal negotiations with the Pool and/or have licensed to the Pool. Continued support from various stakeholders is essential to ensure we can obtain the best possibleresults in future licences.
We look forward to continuing to actively engage with civil society groups around the world.
Ellen ‘t Hoen,
Executive Director
Medicines Patent Pool
www.medicinespatentpool.org
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Medicines Patent Pool
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CH-1211 Geneva 2
Switzerland
E-mail: office@medicinespatentpool.org
website: www.medicinespatentpool.org