Written evidence submitted jointly by
The Association of the British Pharmaceutical Industry (ABPI), the British Generic Manufacturers Association (BGMA) and the Proprietary Association of Great Britain (PAGB)

The Association of the British Pharmaceutical Industry (ABPI), the British Generic Manufacturers Association (BGMA) and the Proprietary Association of Great Britain (PAGB) together represent the major producers of branded pharmaceuticals, generic and biosimilar medicines, over the counter medicines and food supplements in the UK. We would like to use this submission to raise our concerns around the potential unintended[1] impacts of the Psychoactive Substances Bill, as currently drafted. These relate to the research, development, and production of medicines and supplements by our industries.

Our first concern is to ensure that the Bill does not apply to the legitimate supply and availability of certain compounds, which may have psychoactive properties, but which are used as intermediates, precursors, excipients or active pharmaceutical ingredients (API) in the research or manufacture of medicines. If these were viewed as in scope of the Bill, this could cause significant difficulties in purchasing, importing, and exporting these substances, which would significantly inhibit the production of medicines in the UK. It should also be made clear that arrangements under the current requirements for the purchase , holding and use of chemical precursors set out in the Controlled Drugs (Drug Precursors) (Intra-Community Trade) Regulations 2008 (SI 2008 No. 295)  and the Controlled Drugs (Drug Precursors) (Community External Trade) Regulations 2008 (SI 2008 No. 296) will not be affected by the Bill. The principal aim of these regulations is to monitor international trade and prevent diversion of drug precursors for illicit drug manufacture - to handle these substances a licence is already required.

We also ask that the wording of the Bill or accompanying guidance clearly exclude research compounds, of unknown properties which therefore may be novel psychoactive substances, but that are not intended for human consumption, from the scope and subsequent implementation of the Bill.  Again, any confusion over the applicability of the Bill to research compounds could result in the limitation and/or decline of drug discovery development and research for new treatments in the UK, with the loss to patient care that this would imply.

We understand from the Home Office [HO meeting – Stephen Polly, 17th August 2015] that none of the above compounds are considered to be within the scope of the Bill since they are not intended for direct human consumption. However, this should be made explicit in the draft Bill or associated guidance to preclude any difficulties in purchasing, importing, or exporting these substances, which could have an adverse impact on the research and production of medicines in the UK. We also hope that any such guidance will be published promptly following enactment of the Bill, to reduce the risk of misinterpretation, and potentially put supply of certain substances at risk.

Another concern is that the current scope of the Bill could inadvertently apply to legitimate research involving psychoactive substances, potentially criminalising such research or the supply of substances for such use. The current exemptions covering medicinal products, investigational medical products, and traditional herbal medicinal products, would exempt the large majority of medicines research projects from the scope of the Bill. However, some legitimate research may not be covered by these exemptions. For example research into a novel substance which may have psychoactive properties, which has no history of food use and is not an investigational medicinal product, may fall under the scope of the Bill. We also echo the concerns of the scientific research community that some basic research, for example in the field of neuroscience, which may have implications for our understanding of phenomena such as memory and mental illness and hence have implications for our industries in the long term, may currently fall under the scope of the Bill.[2] Therefore, to avoid putting such significant research at risk, we believe the exemptions must be extended and strengthened to include all ‘bona fide’ research in humans as approved by appropriate Research Ethics Committees.

We are grateful for the opportunity to engage with Home Office officials on these concerns, and are confident that the Government is sympathetic to these issues and committed to ensuring that the Bill does not impact on legitimate research, development, manufacture, and supply of medicines in the UK. We look forward to continuing to work with the Home Office to fully address our concerns, through the extension and strengthening of the exemptions within the Bill and issuing of appropriate and timely guidance and we hope that the Committee will also work to secure these changes.

About ABPI

The Association of the British Pharmaceutical Industry (ABPI) represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.

Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.

The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.

About BGMA

The British Generic Manufacturing Association represents the interests of UK based manufacturers and suppliers of generic medicines and promotes the development of the generic medicines industry in the United Kingdom.

We represent the views and interests of our members and industry generally to the UK government, the devolved administrations, regulators, other relevant third parties, including where appropriate the institutions of the European Union.

The BGMA is made up of members of the generic manufacturing industry, who between them account for more than 90% of the total UK market by volume.

A key feature of the strong generics industry in the UK is that it introduces competition to the supply of prescription medicines making drugs more affordable to the NHS and enhancing their availability to patients.

According to the most recent NHS figures nearly 750 million items are prescribed generically every year. The increase of generic prescriptions, allied with a reduction in the net ingredients costs, means that overall savings to the NHS medicines bill have now passed more than £12 billion annually.

About PAGB

The Proprietary Association of Great Britain (PAGB) is the UK trade association representing manufacturers of branded over-the-counter (OTC) medicines and food supplements.

These are medicines and food supplements that can be sold at pharmacies, or retail outlets such as supermarkets and convenience stores, without a prescription.

Established in 1919, PAGB's mission is to ensure self-regulation, support its members and to shape the regulatory and policy environment to help members develop and market products that enable consumers to manage their health and wellbeing.

This includes pre-publication approval of our member companies’ advertising to ensure it is responsible and not misleading, developing a fair and positive regulatory environment that encourages product innovation, and promoting the contribution that self-medication can make to people’s health at no cost to the NHS. 

We believe that self care has an important role to play in helping people to get well, feel well and stay well.