On 23 December 2022, the Italian Medicines Agency (AIFA) published on its website an update concerning the procedures for submitting the Active Substance Master File, which is the document that the manufacturer of the active ingredient is required to submit to AIFA for the active substances contained in the medicine for which a marketing authorization has been applied for.
The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency, the ABPI, and pharmaceutical companies. It includes advice for companies to help them use social media in line with these rules and the rest of the Code, following a huge increase in PMCPA complaint cases during the COVID pandemic, and a consensus from the industry that the previous 2016 guidance on digital communications, which did not cover social media platforms, was outdated and unhelpful given today’s online climate.
The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure.
Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or variations to MHRA, and MHRA will continue to review these applications via the current ECDRP process.
The MHRA also announced that from 1 January 2024, a new international recognition framework will be in place, which will have regard to decisions already made by the European Medicines Agency/European Commission and certain other regulators.
Following concerns expressed about the capacity of Notified Bodies to certify medical devices in accordance with the EU Medical Device Regulation within the transitional periods provided therein, on 6 January 2023 the European Commission adopted a proposal to extend the transitional periods under Article 120(3) of the MDR.
On 11 January 2023, Decree Law No. 4 on “Urgent provisions regarding the procedures for the repayment of the medical device expenditure ceiling overrun” was published in the Italian Official Gazette. Article 1 of the Decree extends to 30 April 2023 the deadline by which companies that supplied medical devices to NHS during the years 2015-2018 must pay the required payback amounts.
On 22 December 2022, the Court of Justice of the European Union ruled on Case C-530/20 concerning the interpretation of Articles 86, 87, and 90 of Directive 2001/83/EC on the advertising of medicinal products for human use.
The Federal Court’s recent decision in Australian Securities and Investments Commission (ASIC) v Scholz (No 2) [2022] FCA 1542 has important implications for those who discuss financial products and services on social media platforms. Handed down on 20 December 2022, the Court’s judgment heralds a warning that social media ‘finfluencers’ may be considered to be carrying on a financial service business and thus are required to have an Australian Financial Services License.
Requests for preliminary rulings made by courts of EU Member States have always been dealt with by the European Court of Justice. Over the years the CJEU handled numerous customs cases on tariff classification, customs valuation, origin and procedural customs law. Due to capacity restraints at the CJEU, an alternative distribution of jurisdiction between the CJEU and the lower EU General Court is proposed by the CJEU. More specifically, the CJEU requests that the EU Commission propose a change to the Treaty of the Functioning of the EU, such that preliminary ruling requests for, amongst others, VAT and customs matters, are to be submitted to the General Court.
The Australian Government has released its Strategic Plan for Payments System: Consultation Paper. It is significant insofar as it demonstrates the current Government’s commitment to reform by creating a fit-for-purpose regulatory framework in respect of payments mirroring international developments. It is also significant in that the paper expressly states that the reform agenda includes implementing a tiered licensing framework for payment services providers. Interested parties are invited to comment on this consultation. Responses are due on 6 February 2022.
This January 2023, the Law for Improper Advertising Practices was declared unconstitutional by the Supreme Court of Justice, considering that it violates the human rights of freedom to work, free contracting, freedom to trade and autonomy of will. However, this ruling is one isolated criterion which is not binding and has no general application yet, as it will only protect those who are parties in the “amparo” action that gave origin to the court ruling (since it is not a general declaration of unconstitutionality). Nonetheless, this is an important precedent that should be used by all the courts to grant the “amparos”, and also will help to pursue in the future a general declaration of unconstitutionality.