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).

Continue Reading UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal areas in the entire world of life sciences laws. Now, the German government is adding another layer of complexity to the existing rules.

On 20 October 2022, the German Parliament has accepted the draft Act for the Financial Stabilization of the German Statutory Health Insurance System („GKV-FinStG“). The new act was subject to month-long controversial discussions within and outside of the Parliament and affected stakeholders. This was due to the fact that the new rules will affect almost all players within the healthcare system, including the health insurers, doctors, hospitals, pharmacies and, especially, the pharmaceutical industry. The new law encompasses significant cost-containment measures as the German healthcare system faces increased costs while, at the same time, the system suffers from a reduced inflow of funds.

Continue Reading Germany significantly tightens Drug Pricing and Reimbursement Laws

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.

Continue Reading IFPMA and EFPIA Publish New Joint Guidance Note on Social Media and Digital Channels

Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf Scholz from the Social Democrats will replace the Merkel administration and will be in office for four years. On November 24, 2021, the new coalition has presented their coalition agreement with their plans for the next 4 years. The agreement needs to be approved by the respective party committees and it is expected that all three parties will approve it.

Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI and ML have the “potential to transform health care” through their ability to analyse vast amounts of data and learn from real-world use.  However, these technologies also pose unique challenges, given their complexity and the constantly evolving, data-driven nature of their development.  The Regulators formed the guiding principles to “help promote safe, effective, and high-quality medical devices that use . . . AI/ML” and to “cultivate future growth” in this fast paced field.

The Regulators predict that the guiding principles could be used to: (i) adopt good practices from other sectors; (ii) tailor these practices to the medical technology/healthcare sector; and (iii) create new practices specific to the medical technology/healthcare sector.  The Regulators expect these joint principles to inform broader international engagements as well.

Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices

On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force.  The rules were introduced by the Social Security Financing Law for 2021 (LOI n° 2020-1576 du 14 décembre 2020 de financement de la sécurité sociale pour 2021 or “LFSS 2021”, available here).  The reform seeks to simplify existing rules, make early access and off-label use more predictable for all users, and ensure the sustainability of these programs for the public health insurance system.  In this blog, we present an overview of the new rules.

Continue Reading New Early Access and Off-Label Use Rules in France

On May 20, 2021 there was a major ransomware attack on the Irish health system.  The centralized HSE (Health Service Executive) which provides and manages healthcare for the Irish population was targeted on May 14, and has seen significant disruption since.  It has described the attack as a ‘zero-day threat with a brand new variant of the Conti ransomware.’
Continue Reading Major Cyber-Attack on Irish Health System Causes Commercial Concern

On 10 September 2020, the German Federal Social Court (Bundessozialgericht – “BSG”) has issued an important decision with significant impact on the drug pricing and reimbursement system. It ruled that a pharmaceutical company can file a direct legal action against the early benefit assessment in the so-called AMNOG process. This was not possible so far.

On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.

One of the main objectives of the

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized