My Lords, I will also speak to Amendments 26 and 27. I am very grateful to Rudi Fortson QC for advising me about the issues I am seeking to resolve with these three amendments.
Amendment 25 seeks to adjust Schedule 1 in order to exempt:
“All medicinal products prescribed by a doctor or sold by a licensed pharmacist”.
In the absence of this amendment, some perfectly legitimate medications prescribed by a medical practitioner may be banned under this legislation. The point here is that the exemption for “investigational medicinal products” does not encompass the supply by a GP on a named-patient basis of a particular medication. The GP will not be acting in pursuance of a clinical trial and thus will not be covered by the exemption of substances used for investigational purposes.
In the Bill no exemption is made for medical practitioners who believe it to be in the patient’s best interests to supply a psychoactive substance that is unlicensed and which does not fall within Schedule 1. The amendment seeks to overcome this problem. I can give the House an example to clarify the point. Acetylcysteine is used on a named-patient basis for cystic fibrosis, pulmonary fibrosis and renal protection. These are not trivial matters; they are very serious and it is really important that doctors are able to prescribe these substances in the future despite the passage of the Bill, which we assume will go through in some form. I hope the Minister has had an opportunity to consider this issue and, if she would find it helpful to discuss it with some experts, I have proposed a few people who would be happy to attend a meeting.
A separate issue is covered by Amendment 26. I thank the Royal College of Psychiatrists, as well as Rudi Fortson QC, for its briefing on this amendment. Here the need is to ensure that research scientists using psychoactive substances in their work to develop new medicines or progress neuroscience research do not have their work hindered by this legislation. I am sure the Government do not intend to interfere with this important sphere of research but I hope they will ensure that the final wording of the Bill achieves fully the objectives of the amendment. The royal college welcomes the Bill’s current exemptions for investigational medicinal products as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004. Moreover, as the ban on psychoactive substances set out in the Bill relates only to such substances that are consumed by humans, this means that research that does not involve human consumption of a psychoactive substance— that is, pre-clinical trials—would not be banned under the Bill.
However, there are some experiments involving humans that sit outside the 2004 regulations. Some biologicals and early-stage pharmacological tools—proteins or
manipulated chemical compounds—would fall outside this definition as they cannot be classified as “investigational medicinal products”. According to the Royal College of Psychiatrists, this is hugely concerning as physiological experiments on humans, for example, or studies in human neuroscience looking at issues such as attention, consciousness and memory-use drugs and amino-acids—not medicines—would therefore be illegal under the Bill, unless exempted via this amendment.
The aim of the amendment is to ensure that all research, including work using humans consuming substances for research purposes—not for fun—but not captured by the Medicines for Human Use (Clinical Trials) Regulations 2004, would remain legal and enable vital neuroscientific research to continue. Without this amendment, laboratory suppliers may be wary of supplying some requested compounds for neuroscience research because of their potential to have a psychoactive effect on humans. This could mean that vital new medicines may never get developed. I would be grateful if the Minister could confirm that she agrees that the term “investigational medicinal products”, as defined by the 2004 regulations, does not cover all research used to develop new medicines or progress neuroscience research, and therefore that this amendment really is needed to protect these crucial areas of research.
At this point, I want to mention the letter to the Home Secretary from the Academy of Medical Sciences, the British Pharmacological Society, the Royal College of Psychiatrists, the Royal Society, the Wellcome Trust and the Society of Biology. They all expressed concern about this issue. The letter welcomes my amendment but makes the point that it “goes some way towards” protecting vital research. I obviously have not managed to go all the way in my amendment. I hope that the Ministers—the noble Baroness and the noble Lord—would agree to meet the key people to make sure that the wording in the Bill really is right at the end of the day.
My final point on this issue is that the problems could of course be resolved by regulations, as indicated in Clause 10. However, this seems far too important a matter to leave to regulations, and I think that all those scientists would be very concerned if it was not in the Bill. I also think I am right in saying that a similar issue was dealt with in the Bill that became the Misuse of Drugs Act 1971. Perhaps the noble Baroness can address that issue, because at least we would therefore have consistency. Even without that point, this matter needs to be dealt with in the Bill to make sure that our research base is not interfered with.
I turn very briefly to Amendment 27, which addresses the possibility that low non-psychoactive doses of potentially psychoactive substances could and should be exempted from the scope of the Bill. How can a Government justify criminalising someone for supplying to someone else a dose of a substance when that dose in itself is not psychoactive? Can the Minister respond to this point or take it away and write to me before Report to clarify the position? The scientists are worried about this because they often use tiny amounts of a psychoactive substance and want all that to be exempted from the Bill. Again, the Minister might find it helpful to discuss this with the experts; I do not pretend to be an expert on this matter myself. I beg to move.