As the UK commences negotiations to leave the member states of the EU (colloquially known as “Brexit”), the European Commission has been swift to remove items from negotiating table. Among these is a pledge to redeploy the newly opened European Medicines Agency (EMA) away from London to another European city, with the added expectation that the UK will help facilitate the move and financially compensate the 1,000 EMA staff members who are relocating.
While the role of the EMA is mostly related to the regulation of new drugs and medicines, the EMA also has a role in the area of medical devices, principally drug combination devices.
Within the EU, drug delivery devices can be regulated in various ways, including as a medicine (if the drug is an intrinsic part of the device), or as a device (if the drug is not intrinsic to the device). For example, an Insulin pump would be considered as a medical device, but an autoinjector would be regulated as a medicinal product.
The FDA takes a more clear view of delivery devices, with a clear definition of a combination device incorporated into its regulations. The classification of a product as a device or medicine is critical to how quickly it can come to market. For medicines, one new drug can take up to 12 years to develop, costing more than $2.5 billion in research and development (R&D) costs. This is a much longer and more expensive process than the development of a typical device, which is brought to market in Europe through the Conformité Européenne (CE) Certification process.
Over the next ten years, the number of drugs being incorporated into medical devices, in an ever more complex manner, is expected to increase in areas such as neurology, cancer therapy, and pain management. Increasingly, the current European approach to the regulation of drug combination devices will be seen as insufficient for its purpose, since the requirements for CE certification, which apply to the marketing of devices in the EU, are far different from the regulations applicable to drugs.
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Regulation of medical devices though the CE certification route mainly takes engineering and manufacturing issues into account. CE certification depends on proportionality; an assessment of the risk of the device based upon its classification, with the manufacturer defining the methodology to achieve conformity. Drug approvals require a more precautionary approach, taking into account data on safety, quality, and efficacy. Clearly, European regulation will need to evolve to stay in step with technical developments.
Approval for drugs in Europe takes place at the national level. The UK has an enviable capability for approvals through the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates both drugs and devices, allowing a more nuanced approach than is possible elsewhere in the EU. The MHRA takes a pragmatic approach to combination devices. The MHRA and EMA work closely together, inspecting manufacturing and clinical trials sites. In 2016, an MHRA inspection of a Pharmaceutics International manufacturing facility in the US highlighted issues that resulted in a review by the EMA of medicines manufactured by Pharmaceutics International.
Following the UK’s exit from the EU, the working relationship between the MHRA and EMA will change, all the more so when the EMA is moved to a site inside the EU. Nominally, the relationship between the EMA and MHRA will change when Brexit is complete in March 2019. However, given the complexity of the administration required for drug regulation, there may be increasing pressure for the EMA to review its policies ahead of the UK’s actual exit, especially since the EU is refusing to consider the matter within the Brexit negotiations.
European regulators and the EMA will lose the dual device-drug regulatory capabilities of the MHRA, as well as the one-stop in-house understanding of the complexity of combination devices. Instead, the EMA may need to consult increasingly with multiple agencies when considering the regulation of new drug delivery devices. This layer of complexity in the decision making process may lead to inappropriate classifications of new products. Misclassification of a device as a medicinal product may also lead to long delays in the introduction of potentially life-saving devices because of the required extra clinical evidence. In addition, misclassification of a medicine as a device may lead to the introduction of an inadequately tested drug to the population.
In time, the EU may develop a more robust regulatory response to combination devices, in the same manner as the US. The final form of these regulations will be determined by a mixture of patient safety and industry needs among the remaining EU member states. These regulations may be at odds with the MHRA and UK legislations, creating a non-tariff barrier for UK drug and medical device manufacturers.