Out-Law News | 23 Oct 2019 | 3:40 pm | 2 min. read
Mark Ferguson of Pinsent Masons, the law firm behind Out-Law, was commenting after both the governing Conservative party in the UK and the official opposition Labour party outlined recent plans that would impact on pharmaceutical businesses operating in the UK and the life sciences sector more generally.
At the party's annual conference last month, Labour leader Jeremy Corbyn pledged to create a new, publicly owned generic drug manufacturer to provide cheaper medicines to the NHS. The measure was expanded upon in a paper the party published at the time, entitled 'Medicines for the Many: Public Health before Private Profit'.
The paper contained a recommendation for the creation of "democratically owned pharmaceutical companies with specific missions to serve the needs of the NHS", and said this could "include the production of new chemical entities as well as of generic medicines that may have had price hikes due to market consolidation or other reductions in manufacturing capacity".
Further measures the paper explored included the government making greater use of existing powers to issue compulsory licences for use of patented medicines to improve patient access to medicines.
These recommendations were framed as necessary due to what the paper described as the "fundamental problems" with the current model for the development of new medicines. The paper referenced a lack of alignment between pharmaceutical companies’ research and development activities and public health needs, an industry short-term focus on profits and generation of shareholder value, and industry's influence over the prices charged for NHS medicines as among the problems.
Through the recent Queen's Speech, which sets out the government's legislative agenda, the Conservatives set out legislative reforms it intends to bring forward that will impact on the life sciences sector.
The proposed Medicines and Medical Devices Bill "will capitalise on opportunities to ensure that our NHS and patients can have faster access to innovative medicines, while supporting the growth of our domestic sector", the government said.
To-date there is little detail available on what exactly will be provided for in the Bill, but the government said the "main elements" of the legislation will include "powers to remove unnecessary bureaucracy for the lowest risk clinical trials", as well as a new scheme for combating counterfeit medicines entering supply chains and a registration scheme for online sellers.
The Bill will also make it possible for a wider range of healthcare professionals to "prescribe low-risk medicines", and enable UK medicines regulators to "develop innovative regulation to enable early access to cutting edge technologies and break new ground in complex clinical trials", it said.
Mark Ferguson said: "While the ongoing uncertainty around Brexit and what it means for business looks set to continue, pharma and life sciences companies should be looking at recent announcements made by the Conservative and Labour parties as an indication of what the industry might be faced with after a general election."
"In the recent Queen’s Speech the Conservatives outlined a proposed Medicines and Medical Devices Bill which is aimed at maintaining UK successes in life sciences post-Brexit. But, if the Bill is brought forward in parliament or included as a Conservative manifesto commitment, industry should keep a close eye on what this will mean for licensing, regulation and the existing legislation for the sector," he said.
"Labour’s proposals included in their ‘Medicines for the Many’ paper are their blueprint to ensure patients get better access to medicines at more affordable prices. Jeremy Corbyn's plans to create a publicly owned generic drug manufacturer and apply compulsory licensing to secure generic versions of patented medicines are two huge changes for the industry to get their heads around," Ferguson said.
"Obviously, businesses will be managing other priorities while the UK’s departure from the EU remains unresolved. However, if and when a general election is called attention will pretty quickly turn to scrutinising the policy pledges being made by political parties. These announcements made by the Conservatives and Labour give an early insight into what the industry could face under a new government," he said.
08 Oct 2019