• Concerns raised about financial implications of being unable to approve new generic drug applications
  • MHRA confirms a “streamlined approach” is needed to approve UK marketing authorisation applications after eight years
  • APBI urges continued cooperation to ensure the best outcome for patients

Pharmaceutical industry leaders have warned the government needs to be “fleet of foot” to avoid a significant cost if a no-deal Brexit disrupts approval of generic and biosimilar medicines.

The Association of the British Pharmaceutical Industry chief executive Mike Thompson told HSJ having “continued cooperation” on medicines is “the best outcome” for patients across Europe.

“We want to make sure there are no delays to [medicines] approvals after Brexit, including generics and biosimilars,” Mr Thompson said. “We need to be aligned to make this happen.”

According to the government’s contingency plans for a no-deal, the Medicines and Healthcare Products Regulatory Agency will not have access to the data provided in support of EU approved products and new generic drug applications “would need to be based on reference products that have been authorised in the UK”.

Concerns were then raised by author Ben Goldacre, who suggested the financial implications of being unable to approve new generics could run to “hundreds of millions” of pounds.

Mr Thompson said the ABPI does not believe there will be “impact in the short term” but stressed the industry would “[look] to find a work around”.

“No-deal [will have] unintended consequences we need to work through,” he added.

Mr Thompson stressed the EU has yet to put plans in place so all patients across Europe can be confident they will receive their medicines.

“[As many as] 45 million packs of medicines a month leave the UK for patients in Europe,” he said. “There is a substantive issue here for Europe and that requires their close attention.”

The MHRA told HSJ in the case of a no-deal there would not be a major short term impact on the approval of generic and biosimilar drugs.

A spokeswoman said for eight years after exit day, the “majority of new medicines” coming out of data exclusivity will have been approved via the EU’s centralised process.

Therefore, the MHRA will have converted these medicines into UK licences and it will be able to use these as reference products in a no-deal scenario.

“Beyond that, if no deal has been reached with the EU, generic and biosimilar applications submitted in the UK would not be able to rely on a European reference product,” she said.

The MHRA stressed it will seek to implement a “streamlined approach” to approve UK marketing authorisation applications “that places no greater burden on industry and ensure patients can access new and innovative medicines”.

Details of such proposals will be subject to a consultation in September, she added.

Warwick Smith, director of the British Generic Manufacturers Association, said it expects it will be possible for generic applications to be made based on reference products. 

”We shall, however, take this up with the MHRA as part of the consultation to confirm the position. It is clearly in no one’s interests for the supply of new generics to be barred or delayed,” Mr Smith said.