An Open Letter to Gilead Demanding Affordability and Access to Remdesivir

By CSOs | Letter | March 30, 2020

In an open letter to Daniel O’Day, Chief Executive Officer of Gilead Science, more than 150 organisations (including Madhyam) and individuals have urged the US biotechnology company not to enforce exclusivity over remdesivir, an experimental drug seen as a potential treatment for COVID-19 patients. The clinical trials for remdesivir are underway in China and elsewhere in Asia to test its effectiveness in treating coronavirus infections. Since Gilead currently holds all patents for the development and production of remdesivir, the key concern is that the company should not be profiteering from the global pandemic if the drug proves effective against the coronavirus.

Following is the full text of the letter issued on March 30, 2020.

Dear Mr O’Day,

We write to request that Gilead takes immediate actions to ensure rapid availability, affordability and accessibility of its experimental therapy remdesivir for the treatment of COVID-19, pending the results of the clinical trials demonstrating its efficacy.

The COVID-19 pandemic has spread across all continents and, to date, nearly 700,000 people have been infected, causing more than 30,000 deaths. Making effective therapeutics available and accessible rapidly for all patients based on their medical needs is essential for all countries to combat the pandemic and may save many thousands of lives.

We are seriously concerned with Gilead’s current approach to remdesivir, which may obscure access to this potentially critical treatment for COVID-19. Gilead holds primary patents of remdesivir in more than 70 countries that may block generic entry until 2031. Despite public health emergency declarations in multiple states and cities in the United States since the end of February, Gilead still sought an orphan drug designation from the US Food and Drug Administration on remdesivir with the aim to obtain further exclusive rights in the US, and only applied to rescind this exclusivity after public criticism in late March. Recently, faced with an overwhelming demand for individual compassionate use of remdesivir, Gilead announced its inability to ensure timely supply and reduced the scale of the programme.

COVID-19 pandemic affects every person. It is unacceptable for Gilead’s remdesivir to be put under the company’s exclusive control taking into account that the drug was developed with considerable public funding for both early-stage research and clinical trials, the extraordinary efforts and personal risks that both health care workers and patients have faced in using the medicine in clinical trial settings, and the unprecedented disaster all countries are facing for their people, their health care systems and their economies. Gilead has a poor track record for ensuring universal access to life-saving treatments and the company’s recent actions with remdesivir provide scant assurance that the company can be trusted to act in the public interest.

We request Gilead to fully recognize the scale and potential consequences of pursuing exclusive rights as opposed to enabling scale-up of production and affordable supply of remdesivir during this pandemic.

We, therefore, urge Gilead to take immediate actions to:

  • Declare that Gilead will not enforce and claim exclusive rights on patents, regulatory and trial data and any other types of exclusivity anywhere in the world;
  • Make publicly available, all data, sample products, and know-how that are needed for generic development and for regulatory processes, to facilitate the ability of production and supply by generic manufacturers worldwide;
  • Improve transparency by disclosing its manufacturing capacity and existing supply and allow independent and proper governance over the allocation of the treatment according to medical needs.

An exclusivity and monopoly-based approach will fail the world in combating the COVID-19 pandemic. Gilead must act in the public’s interests now.

The full list of signatories is available here.

Image courtesy of Suzy Hazelwood from Pexels