My Lords, in drafting this Bill, we have adopted a similar approach to that taken by the Republic of Ireland’s Criminal Justice (Psychoactive Substances)
Act 2010; namely, setting out a broad definition of a psychoactive substance and then circumscribing it with a robust set of exemptions to narrow the Bill’s scope. The current list of exempted substances in Schedule 1 includes substances controlled through existing legislation, such as alcohol, tobacco and nicotine, medicinal products and controlled drugs, and substances where psychoactive effects are negligible, such as caffeine and foodstuffs.
I am delighted to see my noble friend Lady Chisholm of Owlpen in her place with me on the Front Bench. During the Bill’s passage through this House, my noble friend responded to amendments tabled by the noble Baroness, Lady Meacher, and the noble Lord, Lord Rosser, and agreed that we should look again at the drafting of the Bill with a view to strengthening the exemptions for medicinal products and research. As my noble friend Lady Chisholm made clear on Report in July, the Government have no intention through this Bill of fettering the discretion of clinicians to prescribe or direct the supply of substances which, in their clinical judgment, meet the needs of their patients. My noble friend also made it clear that we have no intention of constraining bona fide scientific research. This Government attach the highest priority to research and are committed to removing—or not putting in place—unnecessary regulatory barriers to impede that research in the UK.
During the summer, the Home Office worked closely with a range of public and private organisations to address both points, and I am confident that the new formulation put forward in these Commons amendments effectively responds to the issue and ensures that we have a robust list of exemptions.
Let me deal first with the definition of a medicinal product in Schedule 1 to the Bill. One concern put to us by the noble Baroness, Lady Meacher, was that the definition did not cover so-called “specials”; that is, products which are used in healthcare but have no marketing authorisation. These products have been manufactured or imported, to the order of a doctor and certain other medical practitioners, specifically for the treatment of individual patients to meet their special clinical need.
It is not our intention that medicinal products regulated under the framework provided for in the Human Medicines Regulations 2012 should be caught by this Bill. In defining a medicinal product by reference to a product with certain types of marketing authorisation, we were, on reflection, not casting the net widely enough. Commons Amendment 41 properly aligns the Bill with the regulatory framework for medicines. The Home Office worked closely with the Department of Health and the Medicines and Healthcare Products Regulatory Agency during the summer to revise this exemption.
Following careful consideration, Commons Amendment 41 uses the definition of a “medicinal product” as defined in Regulation 2 of the Human Medicines Regulations 2012. This would mean that any substance which falls within the following definition would be caught by the exemption and so would be outside the scope of the Bill:
“(a) any substance … presented as having properties of preventing or treating disease in human beings; or … (b) any substance …
that may be used by or administered to human beings with a view to … (i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or … (ii) making a medical diagnosis.
The Human Medicines Regulations consolidate the law of the United Kingdom concerning medicinal products for human use, including their authorisation, manufacture, distribution, importation and sale. I can assure noble Lords that we are satisfied that this revised definition covers all medicinal products that are approved for use in the UK. This definition includes investigational medicinal products, homeopathic medicinal products and traditional herbal medicines. That being the case, we can dispense with paragraphs 3 to 5 of Schedule 1, and Commons Amendment 42 removes them accordingly.
The Medicines and Healthcare Products Regulatory Agency will remain the body which regulates activity in relation to medicinal products, whether they are authorised or not, and these amendments and the Bill will not encroach on that. The MHRA is already called upon to determine whether a product meets the definition of a “medicinal product”. This will be an important role going forward to assist with ensuring that the exemption for medicinal products is relied on only in appropriate cases. Our approach will ensure that the regulatory frameworks for psychoactive substances and human medicines complement rather than overlap each other and ensure that the public are properly protected for medicinal and non-medicinal psychoactive substances.
Having dealt with the changes to the list of exempted substances, I now turn to exempted activities. Commons Amendment 11 provides that it would not be an offence under the Bill for a person to produce, supply, offer to supply, possess with intent to supply, import or export, or possess in a custodian institution a psychoactive substance if, in the circumstances in which it is carried by that person, the activity is an exempted activity. Commons Amendment 43 then sets out the list of exempted activities. These fall into two categories. The first exempts legitimate activities of healthcare professionals, while the second covers research. I will explain both in turn.
The exemption for healthcare-related activities will cover healthcare professionals acting in the course of their profession, and ensures that the Bill will not fetter their discretion as clinicians. At the moment a healthcare professional is free to prescribe or direct the supply of any psychoactive substance that is not a medicinal product as defined by the Human Medicines Regulations if, in their clinical judgment, this is in the best interests of the patient. While we do not have specific examples of such substances in mind, we wish to ensure that the Bill does not fetter clinicians’ freedom in this regard.
Commons Amendment 11 will ensure that, either now or in the future, a healthcare professional will not be hindered in offering treatment which in their clinical judgment is right for their patient. There are separate rules, in particular in relation to controlled drugs, which govern which substances a healthcare practitioner can and cannot prescribe which are unaffected by this exemption.
We have defined a “health care professional” using the existing definition in Regulation 8 of the Human Medicines Regulations 2012. This definition includes a doctor, dentist, pharmacist, nurse and midwife among
others. The exemption also extends to people who supply substances to patients in accordance with a prescription issued by a healthcare professional, or at their direction.
Turning to research, while the inclusion of investigational medicinal products in Schedule 1 signalled our intention to exempt research activity, the Government recognise that the exemption fell short of what was required and, as such, failed to cover all research which could be caught by the Bill. I am grateful to the Academy of Medical Sciences and to noble Lords for raising this issue. The Home Office has reconsidered this issue and, after consulting the Department for Business, Innovation and Skills, the Department of Health, the Health Research Authority, the Government Office for Science, the Academy of Medical Sciences, the Association of the British Pharmaceutical Industry and the devolved Administrations, we have identified a revised approach.
Given that a wide range of bodies might undertake relevant research, our approach has been to frame the exemption around research which has received appropriate ethical approval from an ethics review body. We understand that all research which will be caught by the Bill should receive such approval. We have discussed this approach with the Academy of Medical Sciences and others in the research community, who are content with our approach.
All research that is approved by one of the Health Research Authority’s research ethics committees will be exempted and, as the Health Research Authority’s remit covers health and social care research, we expect that this will be a major mechanism for the exemption of research. We acknowledge the possibility of research in fields other than health and social care and, for that reason, the exemption will also cover all research approved by: an ethics committee constituted by a government department; an NHS body; a research institute, including universities; or a charity which is concerned with advancing health or saving lives.
These mechanisms for ethical approval are already in place and the Government believe that any research involving the consumption of a psychoactive substance by a human should be considered by an ethics committee, not least to give due regard to the safety of the research’s participants. From our discussions with the research community over the summer, we have not been able to identify any example of in-scope research which has not been considered by an ethics body, so this exemption should not create any additional bureaucracy for the research community, nor require bona fide researchers to do anything they do not already do. We are just conscious not to create a loophole which allows head shops and others to undertake so-called research to facilitate the supply of these substances. It is worth putting on record again that a considerable amount of scientific research falls outside the scope of the Bill in any case. Only research involving the consumption of a psychoactive substance by a person would be caught.
Commons Amendment 11 includes a power to add to or vary the list of exempted activities in the new schedule inserted by Commons Amendment 43. This regulation-making power effectively replaces that in Clause 10, so Commons Amendment 12 omits that
clause. Commons Amendments 2 to 4, 7, 8, 13, 29, 30 and 38 are all consequential on Commons Amendments 11 and 43.
I was asked about poppers. The Government recognise that representations have been made to the effect that poppers have a beneficial health and relationship effect. In consultation with the Department of Health and the Medicines and Healthcare Products Regulatory Agency—the MHRA—the Home Office will therefore consider, following the enactment of the Bill and before the Summer Recess, whether there is evidence to support these claims and, if so, whether it is sufficient to justify exempting the alkyl nitrites group, or individual substances in that group. Clause 3 enables the Home Secretary, by regulations —after statutory consultation with the Advisory Council on the Misuse of Drugs and subject to the affirmative procedure—to add to the list of exempted substances in Schedule 1 to the Bill.
Finally, I thank all those in the medical and research community, as well as those in government departments and this House, who assisted us over the summer in drafting these amendments. I now believe that we have a strong exemption list which meets the guiding principle. I beg to move.