In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Grant Castle discuss developments in the African Medicines Agency and regulatory convergence.
EU Talking Life Sciences Audiocast: WHO Prequalification Procedures in Africa
In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Roderick Dirkzwager discuss WHO prequalification procedures in Africa.
New ABPI Code and PMCPA Constitution and Procedure Published
Those of us who advise on medicines advertising issues have been waiting for much of 2024 for the Association of the British Pharmaceutical Industry (“ABPI”) together with its self-regulatory body for pharmaceutical advertising, the Prescription Medicines Code of Practice Authority (“PMCPA”), to publish the new Code of Practice for the Pharmaceutical Industry (“ABPI Code”). On 23 September 2024, the suspense finally lifted, with the publication of the ABPI Code 2024 (available here). The 2024 ABPI Code replaces the previous version from 2021.
The new ABPI Code incorporates an updated PMCPA Constitution and Procedure, which sets out the procedure for adjudicating upon advertising complaints.
The ABPI initially proposed, and consulted upon, updates to the ABPI Code from December 2023 to February 2024 (please see our previous blog post discussing these proposals here). The 2024 ABPI Code includes most of the changes that were proposed and consulted upon, usually with only minor changes to wording. The PMCPA has issued summaries of the changes to the Code and Constitution, which can be found here and here.
The main headline is that the new ABPI Code is very similar to its predecessor. The consultation received over 3,000 comments, with many commentators calling for more extensive changes than those proposed. The ABPI appears to have resisted these calls, preferring evolution over revolution.
The changes take effect on 1 October 2024. However, a transitional period will operate from 1 October 2024 to 31 December 2024, during which time no material or activity will be regarded as breaching the ABPI Code if it fails to comply with the new requirements of the 2024 version. The 2024 ABPI Code will come into full force on 1 January 2025. Notably, though, the PMCPA will begin operating in accordance with the new Constitution and Procedure from 1 October 2024, including the legalistic elements and abridged complaints procedure discussed below.
Of the (relatively few) changes, what should legal and compliance teams take note of?
The new PMCPA Constitution and Procedure makes changes to the process for investigating and adjudicating upon advertising complaints. These changes aim to enhance the flexibility and efficiency of the complaints process. They include: (i) powers for the PMCPA to issue case management directions; and (ii) a new abridged complaints procedure that could apply in certain cases. The changes will likely result in a more legalistic feel to PMCPA proceedings. If the PMCPA notifies a company of a complaint, it may be beneficial to involve legal teams early in the process.
By contrast, changes to a company’s compliance obligations under the new ABPI Code are relatively modest. The updates are generally clarificatory in nature. Some changes essentially consolidate and codify into the Code principles that already exist in guidance and previous PMCPA cases. An example of this is how companies fulfill their obligation to maintain high standards. There is now more detail on this point in the Code, pulling together concepts from various cases.
There are also new rules permitting the use of QR codes to provide access to prescribing information in certain cases.Continue Reading New ABPI Code and PMCPA Constitution and Procedure Published
Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices
On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesSoon a new global tax on products developed from “digital information” from biological materials? 5 key takeaways for companies from recent UN negotiations
Photo: View from the business delegation to the negotiations in Montreal, of which Covington were part.
On August 16th, 2024, in Montreal, Canada, parties to the Convention on Biological Diversity (“CBD”) agreed on the draft text (“Draft decision”) for the operationalization of the Global
Continue Reading Soon a new global tax on products developed from “digital information” from biological materials? 5 key takeaways for companies from recent UN negotiationsGermany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations
Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German
Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectationsGermany prepares new National Strategy for Gene and Cell Therapies
1. Background
Gene and cell therapies are on the rise. On June 12, 2024, the German Federal Government was handed the strategy paper for a National Strategy for Gene and Cell Therapies. The paper is intended to serve as a basis for policymaking to give Germany a leading
Continue Reading Germany prepares new National Strategy for Gene and Cell TherapiesEU Talking Life Sciences Audiocast: Green Claims – Recent Developments in EU Regulation and Enforcement
In this episode of Covington’s Life Sciences Audiocast, Seán Finan discuss some important recent developments in the regulation of sustainability and green claims and labelling schemes, and the ever-increasing enforcement risk that comes with greenwashing.
UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices
On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”). The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an intention to introduce alternative routes to market for medical devices, such as utilizing approvals from other countries and Medical Device Single Audit Program (“MDSAP”) certificates, in addition to the current UK Conformity Assessed (“UKCA”) marking process.
The MHRA has already taken similar steps in the medicines space, adopting a new International Recognition Procedure (“IRP”) in January 2024.
In relation to devices, the Statement applies to certain medical devices placed on the market in Great Britain. For relevant devices, the MHRA proposes to recognize foreign approvals from regulators in Australia, Canada, EU/EEA and USA (which is a smaller number of acceptable regulators than under the MHRA’s IRP for medicines). The Statement expressly excludes a number of medical devices from international recognition, including software as a medical device (“SaMD”) (including AI as a medical device (“AIaMD”)) and companion diagnostic products approved via US 510(k) (a route which relies on equivalence to a predicate).
The proposed framework is a draft and the final version is expected to come into force in 2025 at the same time as future core regulations. It also remains the government’s intention to introduce transitional arrangements for UKCA marked devices at the same time.Continue Reading UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices
EU Talking Life Sciences Audiocast: EU Pharma Law Review – Focus on Incentives
In this episode of Covington’s Life Sciences Audiocast, Marie Doyle-Rossi, Anna Wawrzyniak, and Valeria Sturla discuss the position adopted by the European Parliament on 10 April 2024 on the Commission proposal to reform the core EU pharmaceutical legislation.
Parliament’s position comes less than a year since the
Continue Reading EU Talking Life Sciences Audiocast: EU Pharma Law Review – Focus on Incentives