Vulcan View: The latest EU developments 16 December – 20 December

EU adopts 15th sanctions package targeting Russia’s shadow fleet

The Council of the EU formally signed off on its 15^th Russian Sanctions Package on Monday, 16 December. The package consists of an additional 54 persons and 30 entities responsible for actions undermining or threatening Ukraine’s territorial integrity. The measures are designed to target Putin’s shadow fleet and weaken Russia’s military and industrial complex.

The Council has added 32 new entities to the list of those supporting Russia’s war against Ukraine by imposing stricter export restrictions. These restrictions concern dual-use goods and technologies, as well as goods and technology, which might contribute to the technological enhancement of Russia’s defence and security sector. Some of these restrictions are located in third countries such as China, India, Iran, Serbia, and the UAE.

To protect EU companies, the Council has prohibited the recognition or enforcement in the EU of Russian court rulings that violate international principles, preventing high financial penalties for EU companies. The measure prevents penalties from being executed against EU operators in Europe.

In this context, EU countries have also agreed to establish a mechanism to compensate Euroclear for losses incurred due to Russian court decisions. This measure is relevant for the EU’s €18 billion share of the G7 loan to Ukraine, as it could potentially free up funds or prevent disruptions in Euroclear’s operations, ensuring that the loan to Ukraine proceeds smoothly. Euroclear holds a significant portion of immobilised Russian assets and is currently involved in litigation with sanctioned Russian parties seeking compensation through Russia’s politicised courts.

The EU has extended the deadlines for businesses to comply with rules for withdrawing or selling their operations in Russia. EU operators, however, should consider winding down businesses in Russia and/or not starting new businesses there. The extended derogations are granted on a case-by-case basis by member states and focus on allowing an orderly divestment process.

With Poland taking the EU Council Presidency in January 2025, it is expected that future sanctions against Russia will become more severe. The 15^th Sanctions Package may serve as an early indication of a package in which EU businesses are directed to completely sever all ties with Russia.

The latest full consolidated version can be found here. A 16^th Package, with further focus on energy, is expected in the early months of 2025.

EU-Western Balkans summit signals new momentum for EU enlargement

In a significant display of the EU’s commitment to expansion, leaders from the European Union and six Western Balkans countries (Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia, and Serbia) gathered in Brussels on 18 December for the 2024 Western Balkans annual summit. The meeting, which marked António Costa’s first summit as President of the European Council, resulted in the adoption of the Brussels Declaration, highlighting that the strategic partnership between the EU and Western Balkans is “more important than ever.”

The summit took place against the backdrop of Russia’s war in Ukraine, which is adding urgency to the EU’s enlargement agenda, with Hungary’s Presidency of the Council injecting new dynamism into the process. Additionally, the acceleration of the enlargement process hinges on the willingness of candidate countries to pursue access to a €6 billion Reform and Growth facility, which contains a plan for gradual access to the EU’s Single Market. Moreover, Ms. von der Leyen confirmed after the meeting that the Commission is already preparing an initial pre-financing of €300 million to kickstart reforms in the region.

Notable progress has been evident over the past months, particularly for Montenegro and Albania, who have advanced considerably in their accession talks. Albanian Prime Minister Edi Rama expressed optimism about concluding membership negotiations this decade, while Montenegro aims for EU membership by 2028. New EU enlargement chief Marta Kos suggested that at least one country could complete the accession process during the current Commission’s mandate.

However, challenges remain. The Brussels Declaration highlighted the need for Western Balkan partners to implement fundamental reforms, particularly in areas of rule of law, freedom of expression, and media independence. The document also addressed ongoing regional tensions, notably stating that “the absence of a normalisation of relations between Pristina and Belgrade is holding back both partners”.

The summit introduced practical integration measures, including the expansion of the Single Euro Payments Area to include Albania and Montenegro starting next year, with North Macedonia and Serbia expected to follow. The EU also plans to implement “green lanes” at borders, potentially reducing waiting times by up to 80%.

Regarding the existing problems in the region, German Chancellor Scholz called on Western Balkan countries to “overcome the pettiness” of bilateral disputes, while Council President Costa declared that “bilateralization is not a fair way to deal with accession”. This push for regional cooperation comes as the EU positions enlargement as a strategic imperative, particularly considering Russian influence in other potential member states like Georgia, Moldova, and Ukraine.

Finally, the declaration concludes with a comprehensive annex outlining specific deliverables and priorities, focusing on economic integration, security cooperation, and migration management. While the gathering was largely symbolic, it represented what Costa called “a new momentum” in EU-Western Balkans relations, suggesting a more focused approach to expansion in the coming years.

Embracing digital change in healthcare: the benefits of electronic product information

Overview

The European Medicines Agency is working to facilitate the use of electronic product information (ePI) for human medicines in the EU. EPI pertains to “authorised statutory product information for medicines (including the summary of products characteristics, package leaflet, and labelling)” modified for electronic dissemination. The development of ePI within the EU is backed by the Eu4Health programme 2021-2027 – a vision for a healthier Europe. The EU established the programme in response to the COVID-19 pandemic to enhance “crisis preparedness” in the EU. In 2023, a draft of the reformed EU pharmaceutical legislation called for mandatory ePI on all medicines.

Benefits

The benefits of enhanced ePI include:

• Enhanced access to essential and up-to-date information about medicines for patients and healthcare professionals.
• Accelerated market readiness of medicines as the requirement to produce a printed leaflet is eliminated.
• Improved health literacy by providing videos, audio descriptions, larger text, and other accessibility tools, enhancing patient’s understanding of their treatment.
• Improved sustainability within the medicine supply chain by eliminating the need for paper and printing.
• Digital interoperability to to allow health information to flow smoothly between manufacturers, healthcare professionals, and patients.

Global Outlook 

• Australia: Information on all medicinal products is available via ePI. Paper product information is optional.
• China: In 2024, China adopted an ePI pilot programme that utilises QR codes.
• Japan: In 2021, a government mandate necessitated the need for all patient information leaflets to be uploaded to the Pharmaceuticals and Medical Devices Agency.
• Singapore: In 2021, the Health Sciences Authority approved sharing ePIs through URL or QR codes.
• USA: In 2014, the US Food and Drug Administration proposed amending the requirement that prescribing information be provided primarily on paper. The idea has faced political and legislative resistance.

Progress 

On 16 December, findings from the European Commission and the European Medicines Agency were published regarding a pilot exploring the creation and testing of ePIs in regulatory procedures. The report concluded that the EU is generally ready to begin the phased adoption of ePI. However, the EU requires a “more developed” and “joined up”regulatory system, with extra features and integration within existing IT systems, to handle digitalised medicines information. Furthermore, the report suggested enhancing guidance for ePI users and streamlining business processes to ensure seamless integration of ePI.

Despite the need for further development and improvement, the report specified that “there were no blocking aspects identified that would prevent inclusion of electronic product information (EPI) in regulatory procedures as an add-on to current processes”. The report emphasised that, in 2025, the EU should work towards a phased approach to EPI implementation, beginning with voluntary adoption for centrally authorized products. Following this, the EU should “progressively expand to nationally authorized products based on countries’ readiness and available resources”.

Lastly, the report recommended that the regulatory network, pharmaceutical industry, medicine information providers, and healthcare professionals integrate EPI into their planning and preparation processes. Ultimately, it is the product information from pharmaceutical firms that will need to be adapted upon the introduction of enhanced ePI. Therefore, pharma firms must engage constructively with regulators and solution providers to prepare for the evolution of the technology.

Compliments of Vulcan Consulting – a member of the EACCNY