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Medicines regulation

Avoiding medicines stalemate post Brexit

To avoid a potential lose-lose situation, both the post-Brexit EMA and the MHRA will have to increase regulatory capacity to play a leading role in both Europe and the world in accelerating access to new drugs and improving patient safety.

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With three rounds of negotiations concluded and little agreed, the reality of a no-deal Brexit looms large over both the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA)

On 10 October, Jeremy Farrar, director of the Wellcome Trust, delivered the 12th Annual Lecture organised by the Medicines and Healthcare products Regulatory Agency (MHRA) in London. Speaking to an audience of leaders from across the UK life sciences community, Farrar explained how recent political events in Europe and beyond have shaken the foundations of long-established international structures including medicines regulation. A functioning regulation system ensures that medicines are approved safe and effective before being used widely by patients. The MHRA acknowledged the potential risks regarding Brexit. With three rounds of negotiations concluded and little agreed, the reality of a no-deal Brexit looms large over both the European Medicines Agency (EMA) and the MHRA.

The EMA has a symbiotic relationship with the MHRA for over two decades (see ‘Relocation of the EMA: implications for medicines regulation’). For example, the MHRA pioneered the adoption of the ‘Early Access to Medicines’ scheme, which enables people with serious life-threatening conditions to get new medication before all approvals are finalised, where there is a clear medical need. This has made a huge difference to patients, and has led the way for the EMA to adopt similar principles across Europe. Also, most of EMA’s regulatory work is still done on a national level by agencies such as the MHRA. For example, the MHRA is among the bodies most commonly selected to account for around 4,000 licensing procedures across the EU/European Economic Area (EEA). It is also responsible for about 50% of new marketing authorisation applications submitted in the UK.

A major question from the UK perspective is what the MHRA will not be able to do post March 2019. The annual accounts of the MHRA highlighted several possible challenges. One is that Brexit could jeopardise its ability to oversee safety of medicines. Another is that the agency could fail to fulfil its statutory duties because of a loss of funding. According to the Commons Library, the EMA outsources up to a third of its work to the MHRA and provides a third of its income. The UK Government will need to make this up post Brexit.

The UK Government gave a clear, public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU. But can a particular policy area be treated separate to everything else? A failure to agree to a transition deal in lieu of a permanent arrangement before March 2019 may propel both bodies into the unknown. The regulatory system across Europe has developed over many years, and works well. The EMA’s relocation away from London (see infographic ‘Cities compete to host EMA’) will require substantial time and effort to get back to where it was pre-Brexit. To avoid a potential lose–lose situation, both the post-Brexit EMA and the MHRA will have to increase regulatory capacity to play a leading role in both Europe and the world in accelerating access to new drugs and improving patient safety.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203791

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