In a judgment handed down today, 10 July 2023, Mr Justice Turner refused permission for an application by the British Generic Manufacturers Association (BGMA) for judicial review of the refusal of the Secretary of State for Health and Social Care (SoS) to appoint it as a second “industry body” (in addition to the Association of the British Pharmaceutical Industry (ABPI)) for the purposes of negotiation of the next voluntary scheme controlling the prices of branded health service medicines. The result of this decision is that negotiation will involve only the SoS and the ABPI, albeit taking into account submissions from other industry bodies (including the BGMA) and other stakeholders.Continue Reading BGMA refused permission for judicial review in relation to negotiation of the voluntary scheme
On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published by PMCPA in 2016, the large number of complaints since that time is evidence of continued uncertainty regarding permitted activity in this area.
However, while the Guidance acknowledges the challenges introduced by the “open and transitory” nature of social media, it broadly reflects recent PMCPA decisions and rejects the more permissive approach that some stakeholders had advocated was appropriate. Nevertheless, the additional clarity provided by the Guidance is welcome and, by defining general principles applicable to use of social media and issuing more detailed guidance in certain areas, PMCPA has provided a framework to assist companies in managing their social media activity going forward. Continue Reading UK PMCPA publishes long-awaited guidance on use of social media
The VPAS Payment Percentage for 2023, including the adjustments for accumulated Under Payments, is expected to be in excess of 26%. As such, a number of VPAS Members have indicated that they are considering moving from VPAS to the Statutory Scheme. We explore how the situation arose and the implications below.
Continue Reading Concern over high Scheme Payments under the UK VPAS
The UK’s Association of the British Pharmaceutical Industry (ABPI) has, together with the Prescription Medicines Code of Practice Authority (PMCPA), published the new Code of Practice for the Pharmaceutical Industry (the 2021 Code). Publication of the 2021 Code follows a consultation conducted in 2020, with subsequent revisions prior to approval on 12 January 2021.
The 2021 Code will be implemented from 1 July 2021 and represents a significant structural revision of the current 2019 Code. It is described as the most extensive revision to the Code in over 30 years. There is no transition period for the new arrangements after 1 July 2021, other than for medical and educational goods and services (MEGS). The supplementary information to Clauses 20 and 23 sets out a 6 month period (until 31 December 2021) during which ongoing MEGS, provided under Clause 19 of the 2019 Code, may continue without the need to be reclassified as either a donation or collaborative working and comply with any new requirements as a result of this change.
Some of the key changes introduced through the 2021 Code are summarised below.
Continue Reading New 2021 Code of Practice for the British Pharmaceutical Industry
Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.
The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland, on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.Continue Reading Medical Devices and Compulsory Insurance in the EU
The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period for the UK’s departure from the EU (the Transition Period), which is currently scheduled for 31 December 2020. The Bill also consolidates and expands on the existing UK medical devices enforcement powers and provides for an information gateway to permit sharing of information held by the Secretary of State in relation to medical devices.
Continue Reading UK government publishes new draft legislation on medicines and medical devices
Yesterday, the Food Standards Agency (FSA), which regulates foods and food businesses in England, Wales and Northern Ireland, issued its long-awaited statement on CBD in foods.
In January 2019, the European Commission updated the Novel Food Catalogue to state that extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods, as a history of consumption has not been demonstrated. As a result, all extracts of hemp and derived products containing cannabinoids (including CBD) are now regarded by the European Commission as novel. The FSA responded by stating that it accepted the conclusion of the Commission and was “committed to finding a proportionate way forward…to clarify how to achieve compliance in the marketplace in a proportionate manner”.
Following the UK’s departure from the European Union, the current rules on novel foods will continue to apply until 1 January 2021, when the transition period under the UK’s withdrawal agreement from the EU comes to an end. However, the FSA has now confirmed its position on enforcement and prescribed actions which it considers “are a pragmatic and proportionate step in balancing the protection of public health with consumer choice“.Continue Reading Food Standards Agency announcement on CBD
On 6 September 2019, Regulation (EU) 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (the “Regulation”) was published in the Official Journal of the European Union.
Review of the matters addressed by the Regulation was initially prompted by a European Citizens’ Initiative (#StopGlyphosate), which campaigns against the use of toxic pesticides and for reform of the EU pesticides approval procedure.
The new Regulation principally amends Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (the “General Food Law Regulation”). It also amends eight sector-specific legislative acts, concerning genetically modified organisms, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.Continue Reading Strengthened Transparency in the EU General Food Law Regulation
On 15 April we issued a client Advisory summarising the current regulatory environment in Europe and the US for foods and cosmetics containing cannabidiol (CBD).
The status of such products, however, remains uncertain in several important respects. This note therefore identifies areas where developments or clarification are currently anticipated and addresses the use of CBD in vaping products.Continue Reading Update on the EU Regulation of CBD in Foods and Vaping
On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012, was laid before Parliament. These regulations will come into force on 9 February 2019.
The principal purpose of the amendments is to transpose into UK legislation the remaining provisions of Directive 2011/62/EU (the Falsified Medicines Directive), which require two new safety features to appear on the packaging of certain medicinal products, and the associated Commission Delegated Regulation 2016/161/EU (the Delegated Regulation), which sets out the details of these features. However, the Amending Regulations have also introduced an important new provision allowing for “serious shortage protocols” (SSPs) to be put in place for prescription-only medicines (POMs) in certain circumstances, and have extended the types of product containing naloxone (indicated for the treatment of opioid overdose) that drug treatment services may supply in an emergency.Continue Reading Amendments to UK Human Medicines Regulations 2012