MSF Access Campaign analysis of the MPP Licence Agreement with AbbVie for glecaprevir/pibrentasvir (G/P)
Glecaprevir (GLE) and pibrentasvir (PIB) are medicinal compounds approved for the treatment of chronic HCV in adults. GLE and PIB were first approved by the US Food and Drug Administration as a fixed-dose combination in 2017.
For MSF patients who currently cannot be treated satisfactorily with sofosbuvir-based regimens, access to glecaprevir/pibrentasvir (G/P) to form a salvage regimen is essential; however, AbbVie has not yet accepted requests to procure G/P for MSF projects in developing countries, nor provided any information on how to access G/P on ‘compassionate use’ grounds.
Affordable generic versions will take time to develop and are yet to be become available.
With a view to address intellectual property barriers and facilitate the availability of affordable generic versions, the Medicines Patent Pool (MPP) announced a licence agreement with the originator pharmaceutical company AbbVie for glecaprevir/pibrentasvir (G/P) in November 2018.
The MPP-AbbVie licence is publicly available on MPP’s website allowing for a thorough examination of its terms and conditions.
MSF Access Campaign is now sharing its analysis, which describes a number of challenging aspects of the licence with stakeholders and policymakers.
For example, this is the first time a voluntary licence between MPP and a pharmaceutical company has singled out India as a manufacturing-only country. A similar approach has been adopted vis-à-vis China in the licences on Gilead’s tenofovir alafenamide (TAF), ViiV’s DTG, AbbVie’s lopinavir/ritonavir (LPV/r), and BMS’s atazanavir (ATV).
This practice, now endorsed and expanded by the MPP’s voluntary licence agreements, raises ethical questions about harnessing the capacity of developing countries to develop, produce and supply quality medicines while at the same time prohibiting generics companies from responding to considerable unmet medical needs domestically.
While the AbbVie/MPP licence has some positive characteristics, there are multiple shortcomings that can be improved.
We recommend that AbbVie and the MPP revisit the licence and amend relevant clauses to:
- Provide greater clarification on sublicensees’ freedom to operate when patent applications remain pending in countries excluded from the licence territory.
- Expand the licence territory to include – at a minimum – “manufacturing-only” countries like India and additional middle-income countries with high HCV prevalence, including China.
- Extend the territory of the license agreement to cover all low- and middle-income countries so that adult and paediatric patients in these countries can benefit from G/P formulations.
- Make publicly available disaggregated information of the progress of registration of generic medicines produced under the licence, enabling easier public monitoring and procurement forecasting.
- Ensure that sublicensees who develop long-acting injectables can market the formulation in all low- and middle-income countries.
We recommend that governments excluded from voluntary licences (1) review the voluntary licence together with patent status of G/P to assess their negative impact on competition and (2) apply TRIPS flexibilities such as a compulsory licence if necessary to reduce prices of HCV treatment in their country.
We recommend that procurers and funders provide sustainable, long-term funding for civil society to challenge patents to improve access to generic HCV treatment in countries with high HCV prevalence who are excluded from the territory of the license.
Médecins Sans Frontières (MSF) Access Campaign wrote a letter of support to the Malaysian government commending the issuance of a government use license to enable access to an affordable version of the hepatitis C drug sofosbuvir. The license issued by Malaysia on 20 September 2017 eliminated patent barriers and has resulted in the scale-up of treatment in public hospitals throughout the country.
In the letter, the Access Campaign urged the Malaysian government to continue to reject any pressure from pharmaceutical corporations or their political allies to reverse the government use license.
YAB TUN DR. MAHATHIR BIN MOHAMAD
Prime Minister's Office,
Main Block, Perdana Putra Building,
Federal Government Administrative Centre,
YB DR. HAJI DZULKEFLY BIN AHMAD
MINISTER OF HEALTH
Ministry of Health,
Aras 13, Blok E7, Kompleks E,
YB DATO' SAIFUDDIN NASUTION BIN ISMAIL
Minister of Domestic Trade and Consumer Affairs
Aras 13, No. 13, Persiaran Perdana,
c.c. DATUK DR. NOOR HISHAM BIN ABDULLAH
Director General of Health
Kementerian Kesihatan Malaysia
Aras 12, Blok E7, Kompleks E
Pusat Pentadbiran Kerajaan Persekutuan
11 February 2019
Malaysia’s compulsory license for sofosbuvir is a positive step for public health and innovation
Dear Prime Minister and Ministers,
Médecins Sans Frontières (MSF) is an independent, international medical humanitarian organisation that provides emergency medical assistance to populations in distress in more than 70 countries. To make it feasible to treat patients with quality medicines from more affordable and accessible sources, we rely overwhelmingly on generic medicines.
We are writing to express our support for the government use license to accelerate the Malaysian Ministry of Health’s efforts to scale-up hepatitis C virus (HCV) treatment, enabling procurement of generic sofosbuvir for availability in public hospitals throughout the country.
Direct-acting antiviral (DAA) medicines such as sofosbuvir represent a treatment breakthrough for people with chronic HCV, with cure rates of up to 95%, and far fewer side effects than previous treatments. In many of the countries where we work, MSF is able to provide generic DAAs at US$120 per 12-week treatment course of sofosbuvir and daclatasvir, sourcing these two key HCV medicines from quality-assured generic manufacturers in Egypt and India.
Following the adoption of the Doha Declaration on TRIPS and Public Health in 2003, Malaysia became the first country to issue a compulsory license on a medicine to treat HIV. Similarly, in 2017, it was the first country to issue a government use license for HCV treatment. These decisions illustrate the Malaysian government’s commitment to provide lifesaving medicines to its people.
We would like to express our solidarity and support to the Malaysian government in continuing to reject any pressure from pharmaceutical corporations or their political allies to reverse the government use license. Such pressure violates the integrity and legitimacy of the system of legal rights and flexibilities created by the TRIPS Agreement, as reaffirmed by the Doha Declaration for WTO members to meet their rights and public health obligations.
As you are aware, the United Nations Secretary-General’s High-Level Panel on Access to Medicines recognised the problem of access to medicines as a global issue in 2016. As low to high-income countries across the globe continue to face significant difficulties with the excessive pricing of medicines by the industry, we commend the Malaysian government’s leadership in supporting the innovation and development of more affordable medicines to address the HIV and HCV epidemics.
MSF Access Campaign