The UK government has committed to maintaining its existing intellectual property (IP) framework for pharmaceuticals as part of a new trade deal with Switzerland.
The agreement locks in place IP protections in the UK and Switzerland, meaning neither country will be able to amend periods of exclusivity for drugs or usher in generics in a specific indication earlier than planned. However, the deal does not prevent either government from increasing domestic periods of protection.
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The Association of the British Pharmaceutical Industry’s (ABPI) chief executive Richard Torbett said: “The UK and Swiss governments have made explicit their commitment to maintain a strong and proportionate IP regime, which is one of the long-standing foundations of life science innovation in both countries. This message of stability helpfully underpins our efforts to drive more investment in both countries.”
Marking the first time that regulatory data protection (RDP) has been woven into a free trade agreement, the UK government said the commitment would provide confidence to innovative pharmaceutical companies looking to invest in the UK. RDP provides protection to an innovator’s clinical trial data for a certain period, giving the entity exclusive rights to market a new medicine before other companies can begin to market lower-cost, generic versions of that medicine.
The freeze includes a 10-year period of RDP, consisting of eight years of data exclusivity and 10 years of market exclusivity, sometimes known together as ‘eight plus two years’ of regulatory data protection. There are also five years of protection available for certificates that extend the protection of a patented medicine to compensate the manufacturer for time lost while obtaining regulatory approval.
The European Federation of Pharmaceutical Industries and Associations said the commitment shows a “clear leadership from the UK and Switzerland on the importance of a strong IP framework to support life sciences innovation”.
The agreement is of note given the size of the pharmaceutical sectors in each country. Both the UK and Switzerland are amongst the global leaders in drug innovation.
Roche Products general manager, Kate Rowbotham, said: “As the UK arm of Roche, a Swiss-based organisation, we are delighted to see the enhanced cooperation between the UK and Switzerland in this trade deal. Whilst we look forward to seeing the final text, we particularly welcome world-leading standards on IP being codified: this is an important and necessary step that further enhances a pro-innovation environment, which drives a thriving life sciences sector in the UK.”
AstraZeneca UK chair, Shaun Grady, said: “It is particularly important that both countries have recognised the importance of upholding vital IP standards to enable reinvestment in new research for the next wave of medical breakthroughs.”
While the UK government pointed to support from the generics and biosimilar industry, there are some concerns that medicine costs on the NHS could increase. Once patents expire, cheaper generic or biosimilar versions can enter the market, drastically dropping prices. Until then, the NHS relies on reimbursement evaluations that determine whether a branded medication is cost-effective.
In a statement, the UK Government said the deal “maintains the existing balance between supporting pharmaceutical innovation and the NHS’s access to lower-cost generic medicines”.
