Measures to overcome manufacturing and distribution challenges must go hand-in-hand with taking steps to enable access to treatments and vaccines for COVID-19. Viruses do not recognize borders, and bringing COVID-19 under control will require solutions in all countries, regardless of income level. Actions deemed as nationalistic and/or exclusive have – unsurprisingly – attracted considerable criticism.
In March, Gilead Sciences sparked anger by seeking orphan drug designation for remdesivir, a potential treatment for COVID-19. Seven-year market exclusivity with price-setting power is granted to the manufacturer of an orphan drug and there are significant tax incentives, among other benefits. Gilead Sciences was accused of “profiteering” from the crisis, and took the unusual step of asking the US FDA (Food and Drug Administration) to rescind remdesivir’s orphan drug designation. Only weeks later, the CEO of Sanofi provoked an uproar in France when he told Bloomberg News that the U.S. “has the right to the largest pre-order [of its vaccine candidate] because it’s invested in taking the risk”. He subsequently apologized and backtracked on his comments. As the world grows impatient for treatments and vaccines, these two incidents demonstrate that pharmaceutical companies’ social license to operate is on fairly thin ice.
On a more positive note, there are very encouraging examples of pharmaceutical companies working at breakneck speed to lay the groundwork for ensuring global access to potential vaccines for COVID-19. We were not surprised to learn that AstraZeneca and GSK are prioritising access. Both companies, especially GSK, are recognized as leaders in the Access to Medicine Foundation’s Index, which compares pharmaceutical companies’ approach to access to medicine.
We are particularly interested in AstraZeneca’s development of a vaccine access strategy because – unlike GSK – the company is not a vaccine specialist. AstraZeneca has collaborated with the University of Oxford to further develop, manufacture, and distribute the Jenner Institute’s potential vaccine. Our meeting in June highlighted the company’s commitment to broad and equitable access to this vaccine: agreements have already been reached with CEPI (the Coalition for Epidemic Preparedness Innovations), Gavi the Vaccine Alliance, and SII (the Serum Institute of India). If successful, these agreements will facilitate access to the vaccine in countries of all income levels. One important point to note is that neither AstraZeneca nor GSK expect to profit from their vaccines, if they prove successful, while the pandemic is ongoing. In contrast, representatives from Merck & Co and Pfizer have said that they expect to profit from their respective vaccines.
Although the spotlight has largely been on new vaccines, we have also been monitoring the steps pharmaceutical companies – and companies in the broader healthcare sector – are taking in other key areas: developing diagnostic products; supporting investigations into drugs to treat COVID-19; and providing access to customers who may be facing financial hardship.
- Becton Dickinson, QIAGEN and Thermo Fisher have all produced COVID-19 diagnostic products to enable rapid testing, with results generated in as little as one to four hours.
- AbbVie donated a supply of Kaletra/Aluvia (lopinavir/ritonavir) to Chinese health authorities in January for use as an experimental treatment option (since found to be ineffective).
- Novartis committed to donate up to 130 million doses of hydroxychloroquine in March for use in patients infected with COVID-19 and in clinical trials (also since found to be ineffective); and in February Novartis’ generics division, Sandoz, committed to keep prices stable for a basket of essential medicines.
- Eli Lilly announced in April that it is introducing a Program in the US in response to COVID-19, enabling anyone – regardless of employment status – to fill their monthly prescription of Lilly insulin for $35.