The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit. Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week.
The overarching goals of the plan are to put the UK at the forefront of the life sciences industry, thereby cutting the time it takes for patients to access medicines and to give it a leading role in efforts to cure rare diseases. To achieve those goals, the government plans to “remove unnecessary bureaucracy for the lowest risk clinical trials, encouraging the rapid introduction of new medicines.” The outgoing EU clinical trial rules were criticized in some quarters for imposing excessive burdens on small, low-risk studies. The planned loosening of the UK rules is part of a push to make it easier for hospitals to trial and make medicines and diagnostics devices.
The government also wants to use the legislation to drive the Medicines and Healthcare products Regulatory Agency (MHRA) to develop regulations to help companies “break new ground in complex clinical trials.” Other plans discussed in the briefing document include the implementation of a scheme to stop fake drugs from entering the supply chain, plans to register online retailers and the creation of a framework that supports the updating of legislation. The government wants the ability to update legislation on all aspects of life sciences in response to patient safety issues and changes to the UK’s future global relationships.
The government presented details of the planned bill as part of the Queen’s Speech, which is used to set out the legislative agenda for the upcoming parliament. On this occasion, the Queen’s Speech took place in an unusual context that means it is questionable whether any of the proposed texts will be debated and passed. As it stands, the government lacks a majority to pass legislation, meaning it would need to rely on the support of opposition parties to bring the Medicines and Medical Devices Bill into law. The likelihood of the current parliament passing the law is further diminished by the fact that observers expect a general election either this year or in 2020. If the government wins the election, it may then make the Medicines and Medical Devices Bill part of its legislative agenda for the next parliament.
Source: RAPS Link