UK ministers attempt to provide certainty on EMA relations post-Brexit

UK ministers attempt to provide certainty on EMA relations post-Brexit

After a year of uncertainty, a letter written by two senior government ministers has finally sought to clear up what the UK’s relationship with the European Medicines Agency (EMA) might look like after Brexit.

Whether the letter, sent to The Financial Times by Health Secretary Jeremy Hunt and Business Secretary Greg Clark, does clear anything up, is open to interpretation. But it certainly shows a preference for the UK to have a close working relationship with the EMA.

They state that this future cooperation is important “in the interests of public health and safety” and highlight how the EMA, with the UK as a part of it, has had a positive impact in areas such as developing products for rare diseases.

“If patients are to continue to get safe and effective medicines in a timely fashion, the focus must be on agreeing regulatory partnership between the UK and EU”

There is also a pledge that the UK will continue to support initiatives across Europe that will help to develop innovative new treatments such as big data, genomics and research collaborations.

Amid fears that, if it had to develop its own drug approval system, the UK could slip to the back of the queue for new medicines as drugmakers would focus on larger markets first, the letter also highlights the commitment to medical innovation of the government and the Medicines and Healthcare Products Agency, which could potentially fulfil that role.

“Drug development is a global business – and we will look to work closely with the EMA, and our international partners,” the ministers write.

Reflecting the uncertainty, however, the letter – which was signed off by Downing Street – is somewhat vague on what the future of drug regulation in the UK could actually look like in as little as a couple of years.

It adds: “Whatever the outcome of Brexit negotiations, we are clear that should we not achieve our desired relationship with the European Union (EU), we will set up a regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

“We will seek to process licenses as quickly as possible, certainly no more slowly than at present. Our fee pricing will be competitive with current levels. However, our door will always be open to a deep and special relationship with the EU which remains the best way to promote improved patient outcomes both in Europe and globally.”

The Guardian reports that the letter marks a change of position for Mr Hunt, who said in January that he did not expect the UK to remain an EMA member after leaving the EU.

 ABPI asks for reciprocal EU approach

 The Association of the British Pharmaceutical Industry (ABPI), which represents drug firms employing about 220,000 people in the UK, has responded to the ministers’ letter.

“This letter is a welcome recognition that the future of medicines regulation is a key priority for the government as we negotiate a new relationship with the EU,” said the ABPI’s chief executive Mike Thompson.

“It also signals a readiness to take a pragmatic approach to Brexit negotiations that puts people’s health first. This is a great first step and we look forward to seeing more detail in the coming weeks and months.

“If patients in Europe are to continue to get safe and effective medicines in a timely fashion, the focus must be on agreeing regulatory partnership between the UK and the EU.

“The timeframes we need to meet to ensure no disruption or delay mean that confirmation of a reciprocal approach from the EU would provide welcome certainty to more than 500 million patients.”

04-07-2017

Source: https://www.thepharmaletter.com/

July 4, 2017 / Pharma News