LONDON — The U.K. has agreed to lock in controversial intellectual property protections for pharmaceutical firms as part of a new trade deal with Switzerland.
The agreement, announced on Monday, freezes existing patent protection rules, meaning neither country will be able to shorten exclusivity periods, or bring cheaper generic medicines to market more quickly, without breaching its terms.
The move — which marks the first time the U.K. has explicitly written drug patent rules into a trade deal — has reignited concerns that the protections could increase medicines costs for the NHS, as first reported by POLITICO earlier this year.
“The U.K. government is risking our healthcare system and the health of patients in order to reduce its ability to legislate and regulate in the interests of the public — and they’re doing that in order to please the pharmaceutical industry,” said Diarmaid McDonald, executive director at Just Treatment.
But speaking to POLITICO at an event to celebrate the deal on Monday, Trade Minister Chris Bryant rejected the suggestion that agreeing to the demands was a “trade-off” for the U.K., pointing out that Britain’s pharmaceutical industry had also lobbied for the changes.
“It was a concern on the Swiss side and a concern on our side,” he said. “But I’m very glad that we managed to come to an agreement on that.”
Asked about concerns within the Department of Health and Social Care, he added: “There’s always a bit of a negotiation between different departments and sometimes different departments are a bit more anxious than others about different elements. So sometimes you spend more time negotiating with your own government than you do with the people on the other side of the table.”
The commitments
Under the terms of the upgraded trade agreement, both sides will lock in the current level of intellectual property protection, including the Supplementary Protection Certificate (SPC) and Regulatory Data Protection (RDP).
While SPCs extend patent protection for pharma companies beyond the standard 20-year term to make up for time lost during the medicines approval process, RDP stops generic competitors from using pharma companies’ clinical trial data to gain regulatory approval to produce cheaper copies.
The U.K. has committed to maintain its existing 10-year RDP period and the five years of protection for SPCs.
Together, the protections give pharma companies time to recoup the cost of developing new medicines before cheaper alternatives can enter the market.
The move was welcomed by pharma companies, which believe this makes Britain a more predictable place to invest in research, manufacturing and clinical trials, as protections give them time to recoup the cost of developing new medicines.
“The U.K. 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,” said Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry. “This message of stability helpfully underpins our efforts to drive more investment in both countries.”
But health campaigners argue the government is signing away the levers it has to curb the power of the industry.
“The status quo is already deeply damaging for the NHS,” McDonald said. “We are entrenching a system which is failing patients right now, and we’re entrenching a power dynamic that weighs far too heavily in the interests of the industry.”
“If a future government wants to do something about the unsustainable business model of the pharmaceutical industry, it will not be able to do that … because they’ve signed away the power to do that within this trade agreement,” he added.
In Trump’s shadow
The deal follows the controversial pharma deal Britain signed with the Trump administration, which promised to increase NHS spending on new medicines in exchange for tariff-free access to the American pharmaceutical market for at least three years.
The deal is currently facing a legal challenge, after ministers were accused of breaching parliamentary protocol to rewrite NHS drug pricing rules to meet Washington’s demands. A regulation handing the health secretary new powers to direct NHS spending on medicines was quietly passed into law.
“It is outrageous that we are again having the U.K. in a completely undemocratic process with very little levels of scrutiny … continuously folding in the face of [pharma] bullying and giving them more and more power,” McDonald said.