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Industry concerned about ‘rushed’ Brexit withdrawal legislation

The Patents Amendment could weaken the UK’s IP framework, warns biopharma


In among the hundreds of individual pieces of EU legislation that has to be converted into UK law to allow Brexit to take place is one on intellectual property, which has been raising the hackles of UK biopharma industry.

The Patents (Amendment) (EU Exit) Regulations 2018 Statutory Instrument, to give it its proper name, covers the UK’s exit from the EU patent regime, but according to the biopharma industry could actually weaken the UK’s IP framework and damage the country’s reputation as leader in life sciences.

Of particular concern was the impact the Statutory Instrument (SI) would have on supplementary patent certificates or SPCs, which provide up to five years of additional patent life to compensate for the period of market exclusivity lost during the regulatory approval process, according to the Association of the British Pharmaceutical Industry (ABPI).

While the overall intention of an SI is to transpose EU law, it also gives the UK government the power to enact secondary legislation to fill in legislative gaps that arise upon Brexit. Industry concerns seem to centre on how the term of an SPC is calculated in the SI, and specifically it would like this to be calculated based on only a UK market authorisation, rather than the first approval granted by a European Economic Area (EEA) country.

Without that change, Brexit may lead to industry launching new pharmaceuticals later in the UK, they may receive later market authorisation than in the rest of the EEA, and the SPC period for UK launches could be shorter. That could in turn undermine the attractiveness of the UK as a market, according to the ABPI and the BioIndustry Association (BIA).

Consultation promise

A draft of the proposed pharma patent SI has now been approved by resolutions in the Commons and Lords, but questions raised in the upper house towards the end of last week have prompted the government to pledge consultations with industry on the UK’s future IP rights regimen in the event of a ‘no-deal’ Brexit.

It’s a move welcomed by the BIA, which says it has received assurances that if they come into law, the ‘no-deal’ SIs are “a temporary solution, and that government is considering options for a future regime and will consult with business.”

The BIA says that Lord Henley, Parliamentary Under-Secretary of State at the Department for Business, Energy and Industrial Strategy, has said that government will “immediately” start consultations with industry if the UK crashes out of the EU, and that will include discussions about the SPC term.

While he welcomed the assurances, BIA chief executive Steve Bates (below) said the trade organisation was “concerned at the rushed nature of this and other SIs and in particular the adverse signals that they are sending globally.”

Steve Bates

“While our sector is currently thriving - it has much to lose,” he continued. “Maintaining a strong intellectual property framework is essential if the UK wishes to have long-term sustained investment in R&D and remain a globally-attractive location for international investment.”

“Any signals that the UK may not offer the same patent protection after Brexit will adversely impact the global reputation of the UK as a location for the life sciences industry.”

Article by
Phil Taylor

12th February 2019

From: Regulatory, Healthcare



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