Power to make regulations about human medicines

Part of Medicines and Medical Devices Bill – in a Public Bill Committee am 12:00 pm ar 8 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care 12:00, 8 Mehefin 2020

I thank the hon. Lady for her intervention. The reason why the safety of human medicines is listed first is because safety is the paramount objective in everything.

In the life sciences industrial strategy, we have sought to address the challenges faced by the industry, provide an environment that helps companies to grow, and support collaboration between the NHS and industry better to adopt innovative treatments and technologies. Life science is one of the most productive and strategically important parts of the UK economy—it is worth more than £74 billion per annum—and we wish to cement our position as a world leader in that field to allow patients to benefit from cutting-edge treatments as soon as possible. The Bill is a key part of that, and it also keeps safety right at the top of the agenda. It is therefore right that, when we make regulations, the appropriate authority considers their impact and looks at whether they would constrain companies from seeking to bring new and innovative medicines or medical devices to market.

The concern of the hon. Member for Nottingham North is that the consideration of the UK’s attractiveness, if applied, would mean a reduction in regulation on the sector, such that safety concerns would arise. That is simply not the case. I appreciate that he would like clarity on how the attractiveness consideration would work in practice, and the hon. Member for Central Ayrshire quizzed me about that too. The consideration would not mean reduced regulatory barriers to manufacturing, for example, as that would be to the detriment of patient safety. No! We have not sought to define attractiveness in the Bill, because the definition is as it is in ordinary language. There is no hidden or nefarious intent here. We want the UK to remain at the cutting edge of medical advancement, and that is done by recognising that the pharmaceutical industry benefits patients by making innovative therapies available through clinical trials and bringing them to market, or, indeed, collaborating in the event that expedited access to treatments is necessary.

The pharmaceutical industry—and I am sure the hon. Member for Nottingham North will have seen the comments—has generally welcomed the attractiveness consideration as a factor in making regulation, as reflecting the UK’s commitment to the sector as a whole. We have fantastic scientific research in the UK, as we will discuss when we turn to later amendments dealing with the development of medicines. We have the additional benefit of the NHS, and thus access to patients, and we have the funding to back up the aims. The benefit of a working relationship with industry is reflected in the work we have done to respond to the covid crisis, as the Association of the British Pharmaceutical Industry indeed highlighted in its evidence on the Bill. I hope that that reassures the hon. Gentleman that there is nothing nefarious in that term “attractiveness”, but that we merely want to stimulate, to have the most vibrant sector and to ensure that we get innovation and drugs to patients as swiftly—but as safely—as possible.

Similarly, with regard to med devices, we have put in place additional directives in guidance documents drafted to support the changing approach, including requiring device manufacturers whose products utilise tissues of animal origin to ensure that there is adequate risk management, and that there are controls to prevent the spread of certain animal-borne diseases to users of their products, which is what the hon. Member for Nottingham North would expect. It is right that the regulation is made with regard to those affected by it, and that we strike the appropriate balance, where regulation protects the patient but ensures that patients get access as early as possible—an aim that I am sure we would both agree on—by ensuring that the UK market is a place where the life sciences sector wants to bring innovations to market. With respect to veterinary medicines, it is in the UK’s best interest to ensure that effective medicines are available to treat animals and that we have access to the best possible veterinary medicines as companies bring them to the UK market.

We would expect the experts consulted as part of the process of making regulations under the Bill to give their views, and the Secretary of State or the relevant Northern Ireland Department to reach conclusions on the basis of that evidence. If evidence was supplied, as part of the statutory requirement to consult, that a regulatory change would affect patient safety, I would seriously doubt that any decision maker would proceed with that change. The Secretary of State made it clear on Second Reading that patient safety is of paramount importance. Nor would Parliament allow such a change to be made, in all honesty. Innovation and safety are not mutually exclusive, and we want to continue to ensure that our regulatory framework facilitates the furtherance of both a vibrant sector and patient safety, at its heart. We do not want to risk delaying patients’ access to potentially life-changing technologies, which would have consequences for their health and their safety.

The consideration that amendments 22, 24 and 26 would remove is intended to ensure that we take into account the full spectrum of impacts that regulation will have, and to ensure that patients get access to the most innovative treatment as the UK’s regulatory model encourages development of new therapies and medicines. That is in itself intended to improve patient outcomes. Doing what is in a patient’s best interest is at the heart of the Bill. Therefore there is no need for amendments 23, 25 and 27, as we see patient safety not as in conflict with innovation but as complementary to it. On that basis I ask the hon. Gentleman to withdraw the amendment.