MHRA consults on new regulatory framework for ‘no-deal’ scenario

The regulator said it firmly believes "it is in the interests of both the EU and the UK to strike a deal", but that "a responsible government should prepare for all potential outcomes".

The overall approach in a no-deal scenario is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.

This would include decisions on Marketing Authorisation (MA) applications currently authorised through the Centralised Procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities.

"Should we not achieve our desired relationship with the EU, the government will ensure that patients are not disadvantaged by the future regulatory regime. We will establish a regulatory system that continues to protect the interests of patients and strengthens the UK life sciences industry," the MHRA said.

"Whatever the exit scenario, we will continue to ensure that UK patients are able to access the best and most innovative medicines and medical devices and that their safety is protected".

However, as the Financial Times reported, the global market for drug sales is estimated to be worth $844 billion, of which the UK only holds around 2.6%.

Some fear any additional regulatory burdens and their associated costs could prevent or delay some companies from seeking approval for their products in the UK, and that when they do any extra expense from the new process would be regained through price increases.

The Association of the British Pharmaceutical Industry said it would now study the MHRA’s proposals in detail and "submit a response in due course".

"It is important that the UK puts plans in place for a ‘no deal’ Brexit. Pharmaceutical companies continue to plan for all possible outcomes from the negotiations and we will continue to work closely with the Government on their plans.

"But we have been very clear that the best way to protect patients and public health in the UK and in the EU is to agree future cooperation between the MHRA and the EMA on the regulation of medicines."

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