Queen’s Speech 2019 analysis: government seeks new medicines regulatory powers
The Queen’s Speech today laid out the Government’s new legislative agenda as Prime Minister Boris Johnson aims to set an ambitious new trajectory for post-Brexit Britain.
Here we take a look at the proposed Bills and other policies that will impact BIA members and the wider UK life sciences sector.
Medicines and Medical Devices Bill (page 36)
The Government says this Bill will ensure the UK “remains at the forefront of the global life sciences industry after Brexit, giving patients faster access to innovative medicines and supporting the growth of our domestic sector”, according to the document accompanying the speech. It also says it will allow the UK to take a lead role in global research to find cures for rare diseases.
At its heart, the Bill will provide the Government with the executive powers to change the regulation of medicines, medical devices, and clinical trials. Currently, these powers are mostly held by the EU, but, post-Brexit, the Government wants the ability to change regulation depending on the outcome of negotiations and other needs that might arise. It hasn’t provided any concrete indications of the changes it would make, although it does say it wants the UK to be a world-leader in the regulation and licensing of innovative medicines.
There are also references to enabling hospitals to manufacture and trial innovative medicines (presumably cell and gene therapies), implementing a UK falsified medicines system (if not working with the EU’s), and changing prescribing processes.
Commenting on the announcement, BIA CEO Steve Bates OBE said: “The UK has a long history of taking a leading role in regulatory science and novel trial design. It’s welcome news that the Government wants the UK to continue to be at the frontier of the next generation of clinical development of breakthrough products.
“Since clinical trials authorisation and oversight processes is a matter for individual countries across the EU and around the world, this can be delivered whatever type of Brexit (including no Brexit) occurs.
“It’s vital the MHRA remains a globally capable and relevant regulator, where UK patients can still access the latest innovative treatments and products. We hope all members of Parliament will support this welcome modernisation.”
The Queen’s Speech and documents (see page 32 onwards) outlined a number of other Bills and measures affecting the NHS, including new laws to implement the Long Term Plan, a new body to investigate serious healthcare incidents, and reforming the provision of adult social care and mental health.
Science (page 93)
In her speech, the Queen said: “My Government is committed to establishing the United Kingdom as a world-leader in scientific capability and space technology. Increased investment in science will be complemented by the development of a new funding agency, a more open visa system, and an ambitious national space strategy.”
A specific Bill isn’t mentioned, as the actions to make this happen will probably be through other policy mechanisms, although the immigration system will require primary legislation.
As part of this, the Government reaffirmed its commitment to raising R&D investment to 2.4% of GDP by 2027 (although we note it has dropped the “at least 2.4%” used in the Spending Round) and promised further information on how it will do this in the autumn; this might happen around the Budget now planned for 6 November.
The speech also hinted at a new funding agency to back emerging science, which could be modelled on the US Advanced Research Projects Agency favoured by Dominic Cummings, or a global research council mooted by the Adrian Smith Review. The changes to the visa system follow on from previous announcements and are arguably more broadly applicable, meaning they could benefit industry more than previous commitments. We will likely learn more when the Migration Advisory Council publish its findings on a points-based system.
Steve Bates said: “We welcome the Government’s commitment to raise R&D investment in the UK to 2.4%. The life sciences sector is consistently the largest investor in R&D, and we look forward to continue our engagement with R&D funders to ensure public funding leverages the maximum private investment.
Pension Scheme Bill (page 68)
This will likely be a wide-ranging and complex Bill to strengthen the auto-enrolment pensions system and improve regulatory oversight. However, an intriguing part of it is introducing “pensions dashboards” to allow people to access information on their pensions schemes in one place online for the first time. This could be an opportunity for more people to scrutinise how their money is being invested, which in turn could lead them to search for the better financial returns and social benefits that growth sectors like biotech can offer.
Steve Bates OBE said: “We note with interest the proposal to increase the information that savers will have in regard to their pensions and investments, which will increase opportunities for the public to invest in the sector”.
Animal welfare (page 101)
Among measures including banning imports of hunting trophies, is a commitment to recognising animals as sentient beings in domestic law, and that the welfare of sentient animals is taken into consideration in relevant government policy making. This isn’t the first time the Government has tried to introduce sentience as a legal definition, but plans were put on the back-burner as ministers and civil servants discovered how difficult it is to legislate on this concept.
From the life sciences point of view, an unintended consequence could be to prevent the use of some animals or techniques in research, for which there are currently not alternatives, and thus closing down valuable research to understand disease and develop new medicines. We do not believe this would be the intention, but there is a risk that some animal research could be pushed overseas, where it wouldn’t be done to such high welfare and ethical standards as in the UK.
Steve bates OBE said: “We’ll watch carefully the animal welfare bill to ensure it doesn’t have any unintended consequences for our sector.”
Over the next five days, both Houses of Parliament will debate the Queen’s Speech. One day is allocated to each main topic, including on ‘Britain’s Place in the World’, the NHS and the economy. Next week, at the end of the debates, MPs will vote on the Speech. This vote is usually symbolic as it’s rare for governments to lose it.
But it’s important to bear in mind that Boris doesn’t have a majority and is yet to win a parliamentary vote (and has had seven attempts so far). If MPs were to vote down the Queen’s Speech, they would basically reject the Government’s plan and vision for the country. While this would put political pressure on Boris to resign, he is not obliged to do so, and a General Election wouldn’t be automatically trigged. But at that point, opposition parties may be tempted to table a vote of no confidence, maybe once the 31 October no-deal deadline has passed without us leaving, which would trigger a General Election if the Government lost.
If MPs vote to pass the Speech, the Government will introduce the new bills in the coming weeks and months. We have already spoken to the Department for Health and Social Care, which is the department overseeing the Medicines and Medical Devices Bill. We understand that while there is no timeline for the bill as of yet, it will be published soon.
We will engage with our members to ensure their views on the bill and other policies are represented in our response and political engagement, while also working with the Government to ensure the consultation process is transparent and flexible. We will publish more info on our blog when we know more.