On 26 April 2023, the European Commission published its long awaited proposal to revise the EU’s general pharmaceutical legislation. As expected, the Commission’s proposal represents a significant overhaul of the EU medicine rules. Not least the incorporation of the EU’s amended paediatric and orphan medicine rules into a single
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006.
As expected, the draft Regulation significantly shakes up incentives available to the
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.”
This is the first in a series of Covington blogs about the EU’s proposals to amend the current pharmaceutical regulatory framework, which were released today (see here). It introduces some of the key aims and themes and invites readers to read more in-depth summaries as we release them.
The proposals have been in
Tune into the third episode of Covington’s Life Sciences Audiocast, where Grant Castle, Stefanie Doebler, and Raj Gathani discuss social media challenges for pharma companies in Europe and the U.S.
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).
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.
On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act. The Sunshine Act entered into force on 26 June 2022. However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts. This means that realistically the new transparency system will not be operational before 2023. Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes. Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.
Continue Reading The New Italian Sunshine Act: What Companies Should Know And How To Get Ready
In collaboration with Corporate Law Group, New Delhi, India
On December 16, 2021, India proposed amendments to the Biological Diversity Act, 2002 (the “BDA”) by introducing the Biological Diversity (Amendment) Bill, 2021 (the “Bill”). The process to amend the BDA was undertaken in response to long-standing complaints by stakeholders in the Indian systems of medicine, seeds, and research sectors, as well as industry, that existing access and benefit-sharing (“ABS”) processes in relation to Indian biological resources are too burdensome.
The Bill has several objectives. It seeks to attract foreign investment in Indian biological resources, to fast-track research, patent application processes, and transfer of research results, and to decriminalize non-compliance. The Bill also seeks to further the conservation of biological resources in line with objectives of the Convention on Biological Diversity (“CBD”) and Nagoya Protocol to the CBD, to encourage cultivation of medicinal plants, and to support the Indian system of medicines.
The Bill’s proposed amendments are extensive and touch on many different aspects of ABS, but focus mainly on access and access procedures. In this blog, we present the key proposed amendments, as well as next steps in the process for the adoption of the Bill.