Patented by the US company Gilead Sciences, remdesivir is under patent protection in many countries including in India.
K M Gopakumar 15 Apr 2020
The US President’s endorsement of hydroxychloroquine (HCQ), despite no clear evidence of its efficacy in treating COVID-19 patients, generated much interest in this anti-malarial medicine. Originally used to treat chloroquine-resistant malaria patients, HCQ is also used to treat arthritis and systemic lupus erythematosus (SLE). Considered to be less toxic, HCQ is approved for emergency use, and WHO included it as part of its global multilocation trial known as Solidarity Trial. In India, HCQ was initially approved for prophylaxis of COVID-19 for the high-risk population, and is now used for treating patients with severe disease and requiring ICU management.
The recommendation of the National Taskforce to use HCQ for prophylaxis itself generated panic buying and potential stockout for needy patients, arthritis, and SLE. Hence, the Director General of Foreign Trade (DGFT) prohibited the export of HCQ on 25 March 2020 to address the issue of potential stockout. However, the notification provided the following three exemptions to the probations: a) export as part of an advanced export commitment; b) export commitment as a result of an irrevocable letter of credit; and c) export to other countries on humanitarian grounds on the recommendation of the Ministry of External Affairs (MEA), Government of India. These exemptions against the export prohibition were removed on 4th April, and total export ban was imposed through an amended notification.
Citing the MEA, now the media reports that the government has decided to lift the ban. However, the corresponding notification to this effect is yet to be posted on DGFT website. This change in policy happened within two days and said to be in response to the threat of retaliation by the US President. India also lifted export resections on 24 other active pharmaceutical ingredients (APIs) and its formulations on April 6.
The export probation is not unique to India. Many countries have either prohibited or regulated exports of health products as part of their COVID-19 preparedness. WHO asked its Member States to lift the export restrictions. In a joint letter with the International Chamber of Commerce (ICC) to G-20 leaders, WHO stated: “Export bans or limits on the free flow of all necessary medical supplies, medicines, disinfectant, soap and personal protective equipment are significantly hindering the global response effort. We note with severe concern the reported increase of export restrictions for essential health products.” In response to such criticism, G-20 leaders, in the outcome document of the virtual summit meeting on COVID 19, stated: “We will expand manufacturing capacity to meet the increasing needs for medical supplies and ensure these are made widely available, at an affordable price, on an equitable basis, where they are most needed and as quickly as possible. We stress the importance of responsible communication to the public during this global health crisis.”
It is important that while ensuring adequate stocks of medical products, countries should ensure the supply of these products to other countries which are depending on them. Over the years many trade policies forced several countries to give up their efforts to maintain domestic manufacturing capacities in medical products and depend upon the global supply chain. In pharmaceutical products, India emerged as one of the important production hubs of generic medicines. Therefore, countries like India, which is known as the ‘pharmacy of the world’, is under an obligation to supply to other countries which are in need, which is even required to maintain the future business. This obligation applies to all countries including the US. Many view the US’s behaviour as arm-twisting of countries to ensure supply of medical products. Recently, the US has been accused of modern piracy for diverting 200,000 N95 masks ordered by the Berlin police. Therefore, the question is whether the US reciprocates to India for its action by supplying remdesivir, which is said to be the most promising among all medicines currently under clinical trial for COVID-19 treatment.
Although there is an adverse report about the efficacy of remdesivir, Bruce Aylward, Special Adviser to WHO DG, remarked : “There is only one drug right now that we think may have real efficacy, and that’s remdesivir.” Patented by the US company Gilead Sciences, remdesivir is under patent protection in many countries including in India. Hence, the Indian generic companies cannot produce this medicine in normal circumstances. Moreover, the patent was granted only in February 2020, and hence it is not possible for Indian companies to obtain a compulsory license (CL) without government intervention. CL can only be used after the three-year cooling period, which is mandatory as per the Patent Act. Therefore, a generic production is possible only if the government issues a government use license or acquires the patent or waives the cooling period through a notification.
The government intervention to overcome the patent barrier is only a small step towards the manufacturing of remdesivir. In other words, it could remove the legal barriers, but technological barriers will remain, which could be resolved either through the R&D efforts of Indian companies or through the technology transfer from Gilead. According to a report, production of remdesivir, which is an injectable, requires more time than the development of the usual development of a generic version of small molecules. Therefore, Indian companies will take time to introduce the generic version of remdesivir. India is part of WHO clinical trials for the drug; however, WHO is not supplying this front-running medicine for trails in India. Hence, obtaining medicines from Gilead without any condition is important.
In response to the growing criticism for stopping the supply of remdesivir for companionate use, Gilead changed its stand and announced that it would supply more than 140,000 treatment courses by the end of May 2020. Gilead claims that the current inventory is capable of treating 30,000 patient courses assuming 10-day courses per patent. India should use remdesivir to treat COVID-19 patients as part of WHO clinical trial. This result can then help the Indian Government to make available the benefit of this new drug to people, who do not have any efficacious remedy at this moment. Will the Government of India give a chance to the US to prove its friendship with India by asking for access to remdesivir? The US response will clear all doubts about its recent arm-twisting of India.