The current circumstances are unsettling for many reasons, not least because there is still no approved vaccination or treatment for the novel coronavirus (COVID-19).
There are reports of progress being made in all corners of the world in the race to develop a vaccine, as well as of new and improved diagnostic testing products and of existing medicinal products which may show some efficacy in treating the symptoms caused by COVID-19. There is also a pressing need for access to real-world data on the disease, its history, risk and treatment models, as well as on the supply chain. AI is being used to model COVID-19 and is fundamental to the speed of drug development, clinical trials and testing. Collaboration and coordination in the creation, analysis and sharing of key data is essential to the current efforts.
Against this backdrop, the European Medicines Agency (EMA) recently issued a press release urging the pooling of resources to ensure a coordinated investigation into safe and effective potential treatments. At present, the EMA is concerned that several hospitals and academic institutions are looking to start investigational studies locally, or to treat patients under compassionate use programmes. The EMA has highlighted the importance of generating robust and interpretable evidence that can be used to accurately assess the safety and efficacy of the investigational medicinal products tested.
The EMA is advocating multi-arm clinical trials which investigate different agents simultaneously. Such an approach could provide results rapidly and would allow for comparative assessments against the different agents investigated. Further, the EMA is pushing for all EU countries to be involved in such trials. To generate statistically robust data, clinical trials must be sufficient in size, as a concern of multiple small sites carrying out individual studies is that this body of data is unlikely to be generated. A coordinated pan-European approach is therefore required.
In the European Union, clinical trials are governed by the EU Clinical Trials Directive (2001/20/EC), which is implemented into UK law by the Medicines for Human Use (Clinical Trial) Regulations 2004. These regulations provide stringent requirements regarding clinical trial authorisation and the ethical approvals and conduct of approved trials.
Before placing a medicinal product on the market, a manufacturer must obtain a marketing authorisation pursuant to the EU Directive on the Community Code relating to Medicinal Products for Human Use (2001/83/EC), which is implemented into UK law by the Human Medicines Regulations 2012.
The regulatory processes required to obtain the necessary approvals to test, manufacture and then bring a medicinal product to market can be lengthy. Ordinarily, this is important to ensure that:
- the highest quality data is generated to demonstrate the safety and efficacy of the product; and
- the highest quality assessment of that data to ensure that it demonstrates a positive risk-benefit ratio for patients.
Moreover, a health technology assessment may be required to ensure that the product will be reimbursed. Perhaps with this in mind, the EMA has indicated that it stands ready to support those seeking to develop medicinal products, with all available regulatory tools, "to advance and expedite the development of effective measures to fight and prevent the spread of COVID-19".
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has similarly indicated that it has procedures for rapid scientific advice, reviews and approvals. Reflecting the collaborative approach called for by the EMA, the MHRA has also indicated that it stands ready to support researchers, manufacturers and other regulators to develop medicinal products to fight and prevent the spread of COVID-19.
The UK government made its position clear that Brexit would be a "clean break" from the European Union and that regulatory alignment may not be a goal of those in charge, irrespective of the views of industry.
Does the COVID-19 crisis illustrate that no country is an island, but rather that there is huge benefit to companies operating across borders and of regulatory agencies collaborating to ensure the availability of vital medicines for patients worldwide? A more collaborative, aligned approach of mutual recognition means that, during such times of crisis where everyone must pull in the same direction, there is less red tape to navigate. If that is so, should this approach be limited to crisis scenarios, or should we consider this a blueprint for business as usual, whenever that can return?
