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U.K. Pharmas, Regulators Agree on Faster Drug Review

Dispensing pills


26 Nov. 2018. Drug makers and regulators in the U.K. agreed on new review processes for more effective therapies in company pipelines, in exchange for caps on branded drug sales, which is expected to save £930 million ($US 1.2 billion) next year. The head of the Association of the British Pharmaceutical Industry, or ABPI, also tentatively endorsed the country’s exit agreement with the European Union, known as Brexit.

The new drug review processes, announced on Friday, is an agreement in principle between ABPI to accelerate review of new brand-name treatments considered cutting-edge and those from smaller companies. At the same time, the companies agreed to cap the growth of branded drugs to the country’s National Health Service at 2 percent per year for the next 5 years. If sales exceed that level, pharmaceutical companies would repay the difference to NHS.

Smaller companies would be eligible for exemptions from these sales caps. In addition, price controls would be simplified to provide more predictability for companies and NHS. This voluntary Pharmaceutical Pricing Regulation Scheme framework, in effect for about 50 years, is negotiated every 5 years, with the current term expiring at the end of December 2018.

The agreement, scheduled to go into effect in January 2019, gives the National Institute for Health and Care Excellence or NICE, an independent scientific board that assesses drug candidates, authority to accelerate its evaluation of new treatments, particularly those showing the most therapeutic promise or delivering greater value for patients. ABPI says the faster reviews could reduce the time getting new drugs to market by 6 months.

In an ABPI statement, the U.K. Health Secretary Matthew Hancock called the negotiations “tough, but constructive,” noting, “This new deal will be good for patients, good for the NHS and good for the UK life sciences industry. Cutting-edge and best value medicines will be fast-tracked and we will cut our medicines bill by £930 million next year …” Hancock adds, “The deal will also ensure the UK remains an attractive hub for research and investment so the next generation of ground-breaking treatments can be developed here with patients benefiting earlier.”

The industry-government drug review and pricing talks come at the same time the U.K. is negotiating its Brexit agreement from the European Union. The European Council agreement on the U.K. withdrawal from and framework for future relationship with the EU drew a cautious and tentative approval from Mike Thompson, chief executive of ABPI.

“The terms of the deal,” says Thompson in an organization statement released today, “mean that medicines will continue to reach the patients who need them when the UK leaves the EU in March.” While Thompson also notes the “possibility of cooperation” between regulators in the U.K. and European Medicines Agency, he added, “We urge politicians to move swiftly to confirm the closest cooperation in regulation and scientific research which will maximize Europe’s ability to compete globally. Without this, the US and China will continue to attract the major share of new life sciences investment.”

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