Open letter to Gilead concerning ensuring access to remdesivir - MSF Access Campaign

More than 150 civil society organisations and individuals and MSF sent an open letter to Gilead expressing concerns about how the pharmaceutical corporation’s current approach to remdesivir, a potentially key treatment for COVID-19, may hinder access for those who need it.

Access to Medicines Ireland stand with MSF Access Campaign to demand that Gilead Sciences ensures the availability, affordability, and accessibility of a potential COVID-19 treatment. Now, and always, we must work together in the public interest.

Open letter to Gilead concerning ensuring access to remdesivir

Dear Mr O’Day,

We write to request that Gilead take 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, over 720,000 people have been infected, causing more than 30,000 deaths. Making effective therapeutics available and accessible rapidly for all people 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 (US) 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.

The 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 healthcare 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 healthcare systems, and their economies. Gilead has a poor track record for ensuring universal access to lifesaving 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 recognise the scale and potential consequences of pursuing exclusive rights as opposed to enabling the 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 and regulatory and trial data, or 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 production and supply by generic manufacturers worldwide; and

- 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 interest now.

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robbie lawlor