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COVID-19: Gilead To Fill Remdesivir Supply Gap In EU

Coronavirus Reignites Compulsory Licensing Debate

Executive Summary

As the US firm prepares to ramp up production of the antiviral for use in coronavirus patients, a debate is growing over whether changes could be made to EU rules that prevent the importation of generic drugs produced under a compulsory license.

Amid concern over the availability of sufficient quantities of Gilead Sciences, Inc.’s remdesivir for treating coronavirus patients in Europe, the company says it is discussing "multiple options" with the European Commission “with the goal of getting remdesivir to European patients as quickly as possible.” Remdesivir was recently approved in the EU for use in COVID-19.

The EU health commissioner, Stella Kyriakides, met company executives on 6 July to discuss supplies of remdesivir for 16 EU countries, including Austria, Belgium, Denmark, Germany and the Netherlands. “Our main objective is to ensure that the needs of patients with COVID-19 can be met as quickly as possible in all EU member states,” Kyriakides said after the talks. “We stand ready to support a coordinated EU procurement procedure to secure swift, broad and fair access.”

Gilead told the Pink Sheet it would share details of the discussions once they became available. In the meantime, it said there was “a limited supply of remdesivir on hand in many countries for use in clinical trials, compassionate use and expanded access programs and temporary exemptions, where these have been issued.”

The company expects this supply to be sufficient to meet current demand in some countries where the pandemic has already peaked, but it “may not be enough to meet all treatment needs in others.” It said the limited supply available for other countries over the next three months would be prioritized first “according to regulatory approvals and authorizations and the incidence of disease, and subsequently by severity of disease, to provide access to patients with the most urgent need for treatment.”

"Unallocated portions of supply through September can be allocated for other uses, including to countries outside of the United States" – Gilead Sciences

Alarm had been expressed in various quarters over the decision by the US to buy up all projected production of the drug through to September.

Gilead said it had agreed with the US government that “unallocated portions of supply through September can be allocated for other uses, including to countries outside of the United States. As we have previously communicated, we have invested significantly to shorten manufacturing timelines, expand our international supply chain and ramp up manufacturing" of the drug to meet global demand.

By the end of June, the company had produced more than 190,000 treatment courses, and now expects to have produced more than two million treatment courses available by December 2020. “To the extent that our manufacturing teams are able to produce more remdesivir than currently anticipated over the summer, we will have additional supply outside the United States,” the company declared.

Other Avenues?

Following the announcement of the US supply deal, it had been suggested that compulsory licenses might be an option for providing Europe with enough remdesivir supplies. However, this appears to be an unlikely way forward, given the current legislative situation in the EU.

Adrian van den Hoven, who heads up the generic and biosimilar industry body Medicines for Europe, told the Pink Sheet’s sister publication, Generics Bulletin, that compulsory licensing would be “practically speaking inapplicable in Europe”.

He said the commission had not had any discussions with Medicines for Europe on this issue or compulsory licensing in general, and suggested this was perhaps “because the commission knows that compulsory licensing is practically speaking inapplicable in Europe because the commission drafted the compulsory license regulation to ensure it could never be used in practice. We already warned many years ago that this legislation was incompatible with EU rules on data exclusivity and were totally ignored.” (Also see "Remdesivir Compulsory Licensing Is A Dead End For Europe" - Generics Bulletin, 2 Jul, 2020.)

The difficulty of using compulsory licensing for products like remdesivir in the EU was confirmed by Jaume Vidal, senior policy advisor, European projects, at the NGO Health Action International. He told the Pink Sheet that EU data exclusivity clauses, and in some cases supplementary protection certificates (SPCs), were the main regulatory hurdles that made issuing a compulsory licence “an almost impossible task; this was widely known in both Brussels and by EU member states.”

Importing generics under compulsory licensing also seems to be another dead end. Vidal noted that the EU had opted out of Article 31 bis of the World Trade Organization's TRIPS agreement, meaning that it and its member states were ineligible to import medicines manufactured in another country under a compulsory license. This, Vidal said, was “a move that many welcomed at the time but today wish could be undone.”

Generics In Egypt, India And Pakistan

Generic versions of remdesivir are becoming available, but these are being manufactured under non-exclusive voluntary licenses granted by Gilead to manufacturers in Egypt, India and Pakistan, and are intended for use in less well resourced countries.

The companies are Cipla Limited, Dr Reddy's Laboratories, Eva Pharma, Ferozsons Laboratories Limited, Hetero Drugs Ltd., Jubilant Laboratories, Mylan Pharmaceuticals Inc., Syngene (Biocon), and Zydus Cadila Healthcare.

Mylan has just received Indian regulatory approval for its 100mg/vial remdesivir product, Desrem, which will be available for restricted emergency use this month priced at US$64. Hetero and Cipla launched their respective remdesivir products in India in June.

"Middle and high income countries will be excluded from getting licensed generic versions of remdesivir" – Jaume Vidal, HAI

Gilead said the agreements allowed the companies to manufacture remdesivir for distribution in 127 countries. “The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access,” the company noted.

“The licensing agreements that Gilead has signed with manufacturers in India and Pakistan are not public but it is know that middle and high income countries will be excluded from getting licensed generic versions of remdesivir,” said Vidal.

“This venue would be closed to the EU member states and UK who could try to get a second license from a third country at their own legal peril,” he observed. “The flicker of hope, and it’s a dim one in our view, comes from least developed countries (LDCs) taking advantage of their status (no patent protection for pharmaceuticals yet) to manufacture generic version of remdesivir. For example, in Bangladesh manufacturers are supplying public hospitals, free of charge.”

Efforts To Change Compulsory Licensing Rules

Some moves are being made to address the compulsory licensing situation regarding the EU. In May this year, Bernd Lange, chair of the European Parliament’s committee on international trade, wrote to trade commissioner Phil Hogan asking for clarification of the EU’s decision to opt out from Article 31 bis on compulsory licensing and what tools the EU had available in the COVID-19 context.

Hogan replied that the commission was monitoring the situation carefully, in close contact with member states, and that it would “not hesitate to take the necessary action if the need arises, also as regards the EU’s non-importer status under Article 31 bis of the TRIPS Agreement.”

The NGO, Knowledge Ecology International, said this was “significant because there has been a debate on whether or not WTO members that initially opted-out as importing members can ever change their minds. At least in this communication, Hogan has indicated that changing the status is on the table, and this will have political consequence in any subsequent WTO decision.”

"Governments aside from Israel have not felt the need to enforce compulsory licensing, given the proactively collaborative approach taken by life sciences companies in tackling the outbreak" – Marie Manley, Sidley Austin

According to Marie Manley of law firm Sidley Austin, a number of countries, including France, Germany and Israel, have passed legislation allowing their governments to implement compulsory licensing in the context of COVID-19. “So far, Israel is the only country to actually grant a compulsory licence, for the importation of generic versions of Abbvie’s Kaletra (containing lopinavir and ritonavir)," she said.

Manley noted that the World Intellectual Property Organisation had published a “COVID-19 IP Policy Tracker” that records intellectual property policy changes implemented by WIPO member states in their response to the pandemic, “including these legislative and regulatory measures, as well as voluntary co-operation within the scientific community.”

As of yet, she noted, “governments aside from Israel have not felt the need to enforce compulsory licensing, given the proactively collaborative approach taken by life sciences companies in tackling the outbreak.”

Public health advocate Ellen ‘t Hoen said that the Netherlands had been due to examine an amendment to its patent law at the end of June to give the health minister the power to issue a compulsory license, which currently requires the collaboration of the minister of economic affairs.

Vidal said that overall, the remdesivir affair showed there was a need to “consider such health technologies as global public goods that may be distributed according to epidemiological needs and not purchasing power or political clout.” The work of the World Health Organization “as honest broker and global health steward, embodied by the COVID-19 technologies pool (C-TAP), is more relevant (and needed) than ever,” he concluded.

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