- On 12 May 2020, Gilead Sciences announced voluntary licenses to five generic manufacturers in India and Pakistan allowing them to produce and sell generic versions of its drug, remdesivir, which is currently being tested for use in the treatment of COVID-19.
- As things stand, if the drug proves to be effective, Moroccan generic manufacturers will not be able to produce the drug locally. Remdesivir is patent-protected in Morocco until at least 2031.
- Civil society organizations, ALCS, AMDH and ITPC-MENA, are calling on the Moroccan government to issue a compulsory or ‘government-use’ license on all drugs and technologies with potential to treat COVID-19. If national generic manufacturers remain banned from producing the drug, access is at risk.
“Although Morocco is one of the countries that could be supplied under this license, Gilead’s decision is not good news for our country,” says Othoman Mellouk, Make Medicines Affordable campaign lead and founder of ITPC-MENA.
“If the trials of remdesivir yield conclusive results, an effective national response to the pandemic will require domestic production. Depending on foreign sources of supply in the midst of a global health crisis will not be easy, as we have seen with health products being requisitioned as they transit through a number of countries, or with the scarcity of protective masks, due to manufacturing being concentrated. What stood Morocco apart was its ability to act fast, for example, manufacturing masks locally instead of relying on delayed imports. The same will be required with any medicines approved.”
Originally developed by Gilead for use against the Ebola virus, remdesivir is now also being tested as a treatment for COVID-19. In Morocco, the drug is under a patent (MA35665), which is not due to expire until 2031. A further, abusive, patent that seeks to extend the term of protection has also been filed by Gilead and is currently under examination (EP16770866).
If this secondary-patent were to be granted, Gilead’s patent-protection would be extended until 2036. Although patent holders are granted a market monopoly until the patent expires, the government has the right to suspend this protection for public health reasons and to allow domestic production, as outlined within the flexibilities of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)
“We call on the government to immediately apply Article 67 of Law No. 17-97 on industrial property related to government-use licenses on the remdesivir patent and also to any health products (medicines, tests, technologies) that may be needed to tackle COVID-19,” says Prof. Mehdi Karkouri, President of the ALCS.
“This measure will ensure that our national industry is ready to respond to national needs in a timely manner.”
The article in Moroccan law that Karkouri refers to provides for the granting of “government-use licenses” for pharmaceutical products through an administrative act, upon request by the public health authority. This provision applies when medicines are not available “in sufficient quantity or quality,” or because of “abnormally high prices”.
Furthermore, negotiation with the patent-holder is not required for such licenses. This provision enables domestic needs to be met but it can also be used to export medicines to countries that do not have sufficient production capacity of their own.
This could allow for Morocco not only to ensure supply within the country but also to use its generic manufacturing capacity to come to the aid of several countries that are not covered under Gilead’s license.
The three organizations also call on Moroccan generics manufacturers to step up to meet their “national responsibility” in responding to the pandemic. Their role will be essential if demand is going to be met.
“As soon as the results of the various ongoing clinical trials are confirmed, global demand for proven effective medicines will sky-rocket,” says Dr. Aziz Ghali, President of the AMDH.
“It is highly unlikely that five generics manufacturers would be able to meet such demand alone. What guarantees are there that Morocco’s supply will be prioritized? What prices will Morocco be forced to pay? What will happen if a producer or transit country decides to requisition all of its production to secure its own domestic needs first, as India did last March? Our country must be ready for all scenarios and make use of all existing legal instruments to avoid being left behind,” Ghali concluded.
For media enquiries please contact:
- Aissam Hajji, Advocacy Officer for the International Treatment Preparedness Coalition, Middle East and North Africa region (ITPC-MENA): [email protected] (+212) 661993587
- Moulay Ahmed Douraidi, National Coordinator for advocacy and human rights at the Association Against AIDS (ALCS): [email protected] (+212) 655511362
- Aziz Rhali, President of the Moroccan Association for Human Rights (AMDH): [email protected] (+212) 661041264