EMA Releases Guidelines For Compassionate Use of Remdesivir for COVID-19

The European Medicines Agency on Friday issued new guidance supporting the use of Gilead Sciences’ antiviral remdesivir as a COVID-19 treatment under compassionate use programmes.

The new EMA guidelines on remdesivir recommend its compassionate use  in adult COVID-19 patients experiencing severe disease requiring invasive mechanical ventilation.

Such compassionate use programmes are set up by individual country governments to allow patients suffering from life-threatening diseases access to experimental treatments that have not yet received full marketing approval. However, the EMA  issued specific guidance for remdesivir after Estonia, Greece, the Netherlands, and Romania requested an opinion from the agency’s Committee for Medicinal Products for Human Use (CHMP) on compassionate use protocols.

While large, randomized clinical trials remain the “gold standard” for assessing the safety and efficacy of investigational treatments, the EMA acknowledged the need for a ” harmonised approach to compassionate use in the EU to allow access to remdesivir for patients who are not eligible for inclusion in clinical trials,” said Harald Enzmann, chair of the CHMP in a press release.

The CHMP further encouraged Gilead to make remdesivir available in a “fair and transparent” way to all EMA Member States that wished to take part in clinical trials or use the drug under compassionate use.

The EMA move came as controversy continued to swirl around Gilead’s rights to remdesivir in light of growing demand for the investigational treatment. Medicines access advocates have argued that exclusive patent rights on COVID-19 technologies could result in shortages of essential new treatments or vaccines in an accelerating global crisis.

The company just opened an “expanded access” program after temporarily suspending its own “compassionate use” program due to an overwhelming flood of requests from COVID-19 patients unable to enroll in clinical trials.

Under the expanded access program, hospitals and physicians can apply for emergency use of remdesivir for multiple severely ill patients at the same time. Gilead’s own “compassionate use” program will continue, but enroll only pregnant women and children, Gilead CEO Daniel O’Day wrote in a statement.

Medicines Patent Pool Expands Mandate to Support Establishment Of IP “Pool” for COVID-19 Technologies

Meanwhile, the respected Medicines Patent Pool (MPP) threw its support behind a global initiative to create a World Health Organization-led “pool” of intellectual property rights for COVID-19 technologies, saying that it could help facilitate efforts to make key COVID-19 technologies more widely available to countries as they come to market. 

The UN-backed Medicines Patent Pool (MPP) works as an intermediary between pharma companies and global health agencies such as WHO and UNAIDS, to increase access to treatments for HIV/AIDs, hepatitis C, and tuberculosis. MPP negotiates with patent holders for voluntarily licenses of their products to MPP, which then “pools” the intellectual property rights so that generic manufacturers can enter the market. 

While primarily focused on medicines access, the MPP Governance Board temporarily expanded its mandate on Friday to include all potential COVID-19 health technologies, which could potentially include diagnostics and vaccines. With support from Unitaid, MPP’s founding organization, this allows the organisation to contribute IP and licensing expertise on any relevant COVID-19 products to the World Health Organization.

Unitaid’s Board issued an open letter last week supporting Costa’s Rica’s call for the WHO to create a pool of patents for COVID-19 related technologies.

“In these difficult times, the MPP Board recognises the important role that MPP can play to increase access to life-saving products for those who need them most. And importantly, with time of the essence, to ensure that we make use of the expertise and mechanisms that already exist,” said Marie-Paule Kieny, chair of the MPP Board, in a press release.

“The Medicines Patent Pool, set up and funded by Unitaid a decade ago, has a proven track record and is immediately available to the WHO to begin this urgent work,” said Marisol Touraine, chair of the Unitaid Executive Board, reiterating Unitaid’s support for a global “pool” of intellectual property rights.

The organisation aims to follow the lead of WHO, which is currently exploring with other stakeholders the implications of a global “pool” of intellectual property rights, a spokesperson for MPP told Health Policy Watch.

140 Organizations, Researchers, & Educators Call On WIPO To Ensure Intellectual Property Frameworks Support COVID-19 Response

In a parallel move, some 140 organizations, researchers, educators, and students called on the World Intellectual Property Organization to provide clear guidance to governments on using intellectual property laws to support the COVID-19 response.

The COVID-19 pandemic has shone a bright light on how important intellectual property limitations and exceptions can be to development and human flourishing,” the organizations stated in an open letter to WIPO Director General Francis Gurry. For example, data sharing has facilitated cross-border collaboration on COVID-19 research. Schools, universities, libraries, museums, and other research institutions are transferring materials online in the wake of widespread closures. However, remote access to such materials is only available where copyright laws permit. 

WIPO, as the leading agency on global intellectual property, should step in and issue guidance to governments in response to any thorny “intellectual property issues that the coronavirus is raising,” the organizations say.  

The letter suggests WHO take four steps:

  1. Encourage WIPO member states to take advantage of intellectual property flexibilities to increase access to protected works for online learning and research;
  2. Request right holders to remove licensing restrictions that inhibit remote learning, research, and access to culture to both help address the global pandemic and minimise disruption caused by it;
  3. Support the call by Costa Rica for the World Health Organization to pool intellectual property rights for all COVID-19 related technologies and promote use of the Medicines Patent Pool;
  4. Support countries’ rights to enact and use exceptions to trade secret and IP rights to facilitate access to data and technologies needed to increase equitable access to COVID-19 technologies.

Image Credits: Medicines Patent Pool.