This newsletter provides a selection of opinions and analysis from our EU legal experts on interesting policy developments, recent case law and new regulatory directions of major industry practices. It is released biweekly and covers areas such as: Competition Law, Sanctions, Trade, Energy, Finance, EU funds, Data IP and Privacy, Life Sciences, Transport and Court of Justice of the European Union news.

The aim is to provide an up–to–date tool for quick and easy consultation on the most current and important topics at EU level.

• Competition Law and State Aid
• Sanctions
• Trade
• Energy and Green Deal
• Banking & Finance
• EU Funds
• Life Sciences
• Transport and Electric Vehicles
• Data, IP and Privacy
• Consultions and Calls

EUROPEAN COMMISSION (EC)

The European Commission authorizes the first-ever vaccine against Chikungunya virus (28.06.2024) – The European Commission has authorised the first-ever vaccine against Chikungunya virus - a disease transmitted by infected mosquitoes. The EU authorisation of the Chikungunya vaccine is intended for adults over 18 years of age. It was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA). It is up to national authorities in each Member State to decide who will have access to the vaccine, taking into account the national situation and risk status.

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EUROPEAN MEDICINES AGENCY (EMA)

The European Medicines Agency recommends Winrevair to treat adult patients with pulmonary arterial hypertension (28.06.2024) – The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity The opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

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The European Medicines Agency recommends Eurneffyo for emergency treatment against allergic reactions (28.06.2024) – The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the nose for the emergency treatment of allergic reactions (anaphylaxis).The opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

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The European Medicines Agency recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna (28.06.2024) – The European Medicines Agency has concluded its review of the medicine Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorisation be revoked, because its benefits are no longer considered to outweigh its risks. Ocaliva is used to treat adults with primary biliary cholangitis (PBC), an autoimmune condition that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer.

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The European Medicines Agency recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna (28.06.2024) – The European Medicines Agency has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy. Translarna is used in patients whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk.

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This newsletter provides a selection of opinions and analysis from our EU legal experts on interesting policy developments, recent case law and new regulatory directions of major industry practices. It is released biweekly and covers areas such as: Competition Law, Sanctions, Trade, Energy, Finance, EU funds, Data IP and Privacy, Life Sciences, Transport and Court of Justice of the European Union news.

The aim is to provide an up–to–date tool for quick and easy consultation on the most current and important topics at EU level.

• Competition Law and State Aid
• Sanctions
• Trade
• Energy and Green Deal
• Banking & Finance
• EU Funds
• Life Sciences
• Transport and Electric Vehicles
• Data, IP and Privacy
• Consultions and Calls

EUROPEAN COMMISSION (EC)

The European Commission sends Statement of Objections to Alchem over first pharmaceutical cartel case in the EU (13.06.2024) – The European Commission has informed Alchem International Pvt. Ltd. and its subsidiary Alchem International (H.K.) Limited (together ‘Alchem') of its preliminary view that they have breached EU antitrust rules by participating in a long-lasting cartel concerning an important pharmaceutical product. Alchem is a producer of the pharmaceutical ingredient N-Butylbromide Scopolamine/Hyoscine (‘SNBB'). The Commission has concerns that Alchem may have coordinated and agreed with other market participants to fix the minimum sales price of SNBB to customers (i.e., distributors and generic drug manufacturers) and to allocate quotas. In addition, Alchem may have exchanged commercially sensitive information with competitors. In October 2023, the Commission adopted a settlement decision in relation to the same cartel and concerning other companies.

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COUNCIL OF THE EUROPEAN UNION (COUNCIL)

Radioisotopes for medical use: the Council adopts its conclusion (17.06.2024) – The Council of the EU has endorsed its conclusions to secure the supply of radioisotopes for medical use as part of the Belgian presidency's priorities. Reiterating the critical role of radioisotopes for medical use in the diagnosis of cancer, heart conditions and other diseases, Council’s conclusions call on the European Commission to act on five key pillars: (i) Europe's global leadership role in the supply of radioisotopes for medical use, making tangible and rapid progress on the relevant actions identified; (ii) The monitoring and forecasting of demand and supply of all relevant radioisotopes for medical use (iii) Research and innovation on topics related to radioisotopes for medical use and other medical-radiological technologies (iv) The evaluation and development of critical skills (v) The evaluation of the framework for the transport of radioisotopes for medical use to help ensure access by patients in all member states. The Council also urges the European Medicines Regulatory Network to review all radiopharmaceuticals authorized in Europe and assess their criticality according to the existing methodology. Finally, the conclusions emphasize the important contribution of European research nuclear reactors and other nuclear facilities capable of producing radioisotopes for medical use at the levels needed to meet long-term needs in the Union, and the importance of these facilities, as well as the expertise that enables the production of these radioisotopes, continuing to be located in the European Union.

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EUROPEAN MEDICINES AGENCY (EMA)

Faster access to clinical trial information in Europe (18.06.2024) – The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable on 18^th June 2024 in Europe.

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