On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) published an updated Code of Practice for the pharmaceutical industry. Following an extensive consultation with over 3,000 comments, ABPI has announced that the new “orange” 2024 Code amends the previous 2021 Code in three key areas: the PMCPA constitution and procedure; the provision of prescribing information; and certain elements of the Code moving from guidance to mandatory requirements. However, there are also interesting amendments to the requirement to maintain high standards and obligation to seek a lawful basis for disclosure of transfers of value to an individual.

ABPI has said that the new Code seeks to “raise the high standards expected of pharmaceutical companies even further while also ensuring that complaints can be resolved quicker”.Continue Reading A New 2024 Code for the British Pharmaceutical Industry  – “The Future is Orange”

In the UK General Election on 4 July, the Labour Party won 412 of the 650 seats, giving it a comfortable majority. Its leader, Sir Keir Starmer, became Prime Minister, meaning a change of government from Conversative to Labour for the first time in 14 years.

In its campaign, Labour focused on the need to deliver economic growth and innovation in critical industry sectors. It also placed considerable emphasis on addressing the problems facing the National Health Service (NHS), such as long waiting lists for treatment, old equipment and an increasingly ageing population.

The government’s economic priorities were further set out in the first major speech delivered by the new Chancellor of the Exchequer Rachel Reeves on 8 July, in which she said that growth “is now our national mission”. The Health Secretary Wes Streeting also noted his intention of making the Department of Health and Social Care a department for economic growth. While each of these are statements of intent and not binding on the new government, they provide valuable insight into what industry can expect over the next 5 years. We set out below some of the most relevant initiatives that could impact the industry.Continue Reading What does the new UK government mean for life sciences?

Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.

On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years.  Once the new legislation has been approved by the European Council it will become law, and is likely to come into force in around mid-2026. The intention is for EU consumers to have easier access to compensation caused by defective products. 

The International Comparative Legal Guide (ICLG) on Product Liability Laws and Regulations 2024 is now available, and we have prepared:

Continue Reading Implications of the New EU Product Liability Directive

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.

Background

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,[1] 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