Morocco: National Generic Drug Companies banned by the American laboratory GILEAD from producing anti-COVID-19 treatments

ALCS – AMDH – ITPC-MENA Joint Press Release

Casablanca May 13, 2020

Moroccan civil society calls for government use licenses as national generics manufactures are banned from producing anti-COVID19 drugs by GILEAD

On May 12, 2020, U.S. laboratory Gilead announced voluntary licenses to five generics manufacturers in India and Pakistan allowing them to produce and sell generic versions of its drug, Remdesevir, which is currently being tested for use against COVID-19[1]. As things stand, if the drug proves to be effective, Moroccan generic manufacturers will not be able to produce the drug locally because, in the country, it is protected under a patent until at least 2031. The ALCS, AMDH and ITPC-MENA are calling on the Moroccan government to issue government use licenses on all drugs and technologies with potential to treat COVID-19.

“Although Morocco is one of the countries that could be supplied under this license, Gilead’s decision is not good news for our country,” said Dr. Othoman Mellouk, an expert in intellectual property and access to medicines, and founder of ITPC-MENA. If the trials of Remdesevir 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 protective masks… What has saved us and made Morocco’s case exemplary until now is that we were quick to produce what we needed locally,” he said.

Originally developed by Gilead for use against the Ebola virus, Remdesevir 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 granted, the term of protection will be extended until 2036. Although patent-holders are granted a market monopoly until the patent expires, the government does have the right to suspend this protection for public health reasons and to allow domestic production, in compliance with international agreements (flexibilities of the WTO TRIPS Agreement confirmed by the Doha Declaration Member States) and national law. This is known as “government use licenses”.

“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 Remdesevir patent and also to any health products (medicines, tests, technologies) that may be needed to tackle COVID-19. This measure will ensure that our national industry is ready to respond to national needs in a timely manner,” said Prof. Mehdi Karkouri, President of the ALCS.

Indeed, article 67 of this law 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. In this way, Morocco could come to the aid of several countries that are not covered under Gilead’s license, many of them even in the absence of a patent. Domestic industry could also benefit from a larger market contributing to more affordable prices. The three organizations also call on Moroccan generics manufacturers to step up and demonstrate their sense of national responsibility in the face of this global pandemic.

“As soon as the results of the various ongoing clinical trials are confirmed, global demand for proven effective medicines will sky-rocket. 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” concluded Dr. Aziz Ghali, President of the AMDH.

Media contacts:

Aissam HAJJI, Advocacy Officer for the International Treatment Preparedness Coalition (ITPC-MENA): aissam.hajji@itpcmena.org

Moulay Ahmed DOURAIDI, National coordinator in charge of advocacy and human rights at ALCS: doura3s2@gmail.com

Aziz RHALI, President of the Moroccan Association for Human Rights (AMDH): aziz_rhali@yahoo.fr

Ressources:

[1] https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir