Brexit plan reassuring for pharma industry, but uncertainties remain: lawyers
While the UK’s pharmaceutical and biotech industries have welcomed the government’s latest White Paper on Brexit, a number of uncertainties remain, according to lawyers.
The 104-page document, titled “The Future Relationship Between the UK and the EU”, outlines UK Prime Minister Theresa May’s plan for Brexit. It includes ensuring that the “current routes to market for human and animal medicine remain available”.
As part of the proposal, the UK wants a common rulebook for such products so that manufacturers need to undergo only one series of tests in either market (UK or EU).
Glyn Truscott, partner at Elkington & Fife, believes this common rulebook will be a “relief to the industry” and would benefit patients.
The White Paper also provides for the UK’s continued participation in the European Medicines Agency (EMA), with the UK becoming an active participant that contributes financially (but has no voting powers) and UK regulators acting as a “leading authority” for the assessment of new products.
“This should help ensure that UK patients do not face unnecessary delays to access medicines compared to their EU counterparts and should also reduce the administrative burden on industry,” according to Gregory Bacon, partner at Bristows.
The clarification that the UK will seek continued participation in EU research funding programmes is also encouraging, he said.
Bacon added: “This will be important to ensure that the UK continues to maintain its world leading position for research.”
Devil is in the detail
The proposal means very little until it has been agreed with the 27 EU states.
“While the paper provides some much-needed clarity and reassurance on the UK’s proposals, it’s important to remember that the paper only represents the UK’s negotiating position,” said Bacon.
Truscott noted that while it’s a relief to see IP specifically mentioned, there remains significant uncertainty around the Unified Patent Court (UPC) and the unitary patent. The life sciences section of the UPC’s central division is planned to be based in London.
“The UK has ratified the UPC Agreement and intends to explore staying in the court and unitary patent system after the UK leaves the EU,” said the White Paper.
Whether this is possible will depend on the ability for the participants to agree to modify the existing agreement, said Truscott.
He added: “This could ultimately be beneficial if it were to allow for other non-EU countries to join, so that the UPC could perhaps ultimately act as the court for all contracting states to the European Patent Convention and provide a true one-stop shop for litigants.”
For Bacon, the UPC system would represent the most important change ever seen in the European patent landscape, and the continued involvement of the UK would be welcomed by the life sciences industry.
He concluded that, until the withdrawal agreement is signed, the UK pharma and biotech industries will need to continue to plan for all eventualities, including a no deal scenario.
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