The EU Clinical Trials Regulation 536/2014 significantly expanded the transparency requirements for clinical trials in the EU, resulting in the public availability of most documents and information submitted by sponsors to the new EU Clinical Trial Information System. Tune into this episode of Covington’s Life Sciences Audiocast, where Robin Blaney and Roderick Dirkzwager look
Update on the VPAS Judicial Review brought by the British Generic Manufacturers Association
The Voluntary scheme for branded medicines pricing and access (“VPAS”) is a voluntary agreement that regulates the price of the vast majority of branded medicines sold in the UK (including branded generics and biosimilars). VPAS is critical to the commercial interests of most innovative pharmaceutical companies operating in the UK. It has traditionally
EU Pharma Legislation Review Series: Decentralized Manufacturing
The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products. In particular, the Proposal introduces new obligations for manufacturers and for national competent authorities overseeing decentralized sites. In this blog
EU Pharma Legislation Review Series: Supply Security and Shortages Control
As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages. In particular, there are new obligations for Marketing Authorization Holders (“MAH”)
EU Pharma Legislation Review Series: Bolar Exemption under Patent Rights
The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the concept of the Bolar exemption
EU Pharma Legislation Review Series: Regulatory Data Protection
The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products. The Commission stated in its Impact Assessment for the revised pharmaceutical legislation that it wants to strike a balance between “providing attractive incentives for innovation and supporting timely patient access to medicinal products across the EU.”
EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows – Implications for Global Supply Chains
Complex international pharmaceutical supply chains often separate the physical flow of product from financial flows or flows of legal title. Tune in to this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Robin Blaney and Marie Doyle-Rossi, discuss how the EU and UK pharmaceutical rules seek to regulate these tax and
Legislative Proposals for Clinical Trials Aim to Streamline, Simplify and Stimulate UK-based Innovation
On 21 March 2023, the UK Government published its response to the consultation on legislative reform proposals for clinical trials that took place from January to March 2022.
The current legislation governing clinical trials in the UK is the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended. This implements the EU Clinical Trials Directive 2001/20/EC and has not been amended to align with the subsequently introduced EU Clinical Trials Regulation 536/2014.
The proposed reforms centre on delivering “a more agile and flexible UK regulatory framework”, as part of the Government’s broader ambition to create a more appealing regulatory environment for life sciences innovation in the UK. The emphasis on promoting clinical research in the UK was highlighted by the recent Government announcement of an independent review into UK clinical trials, prompted by figures suggesting that the number of industry clinical trials initiated in the UK per year fell by 41% between 2017 and 2021. In addition, a decline in public engagement with clinical research (with a 44% drop in the number of participants recruited to commercial clinical trials in the last five years) highlights the need for reform in this area.
The Government’s proposed reforms involve streamlining the procedures supporting the approval and conduct of clinical trials, removing duplicative requirements, and enabling flexibility in a risk-based and proportionate manner.
The proposals also envisage a clinical trials regime that requires greater transparency and encourages, though notably will not require, a diverse range of patient and public involvement.
The main proposals with which the Government intends to move forward are discussed below.
UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media
On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).
The Guidance is the first of its kind in the UK and is long-awaited.
The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK). The ABPI Code sets out a number of overarching principles but does not address social media in detail. The PMCPA had some years ago published “digital guidelines” but these were archived for updating.
The first – and probably most important – thing to say about the Guidance is that it (finally) exists. Social media has become a major compliance headache for UK pharmaceutical companies. These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn. The absence of clear and codified guidance until now led to a lack of clarity. Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent. While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.
Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach. Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history. It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).
IFPMA and EFPIA Publish New Joint Guidance Note on Social Media and Digital Channels
On 28 September 2022, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) published joint guidelines concerning the use of social media and digital media channels by pharmaceutical companies (Joint Digital Guidelines). IFPMA and EFPIA are umbrella trade bodies for the innovative pharmaceutical industry on the global and European stages, respectively.
The Joint Digital Guidelines are timely. Digital communications and the use of social media have become hot compliance topics for the pharmaceutical industry, both in Europe and globally. Actors in the healthcare world increasingly use digital communication channels; many clinicians, patients and patient organizations actually prefer to receive content digitally. With more content comes higher compliance risk. Digital communications, particularly over social media, can spread fast across borders and are often publicly accessible.
It is no surprise that a very significant number of pharmaceutical advertising cases in European markets now concern digital channels or social media. This certainly reflects our experience; and this is an area where our pharmaceutical advertising experts are continually advising clients.