The State of the Union (SOTEU) speech that the president of the European Union gave on 16 September mainly addressed the current geopolitical landscape and measures to tackle ongoing climate change.
Among other things, the new legislative year should finalise the Single Market, create a European Corporation for critical raw materials, launch a European Care Deal, and launch initiatives to exploit the full industrial AI potential in high-value sectors, including Health and advanced manufacturing.
From an international perspective, President von der Leyen announced the intention to make Canada the first associate member of the EU. A Congress of Europe will also be organised in 2027 to celebrate 70 years since the Treaty of Rome.
The European Parliament discussed the contents of the SOTEU address. MedTech Europe also reacted, underlining the need to translate the announcements into concrete deliverables, for example in public procurement and device regulations.
The Advocate General’s opinion on the EPR scheme
A completely new perspective on the Extended Producer Responsibility (EPR) scheme could open following the opinion of the Advocate General of the European Court of Justice, Juliane Kokott, in case C-193/25. The case concerns an action for annulment of Art. 9(1) and Annex III of the Wastewater Directive (EU) 2024/3019, brought by Poland against the EU Parliament and Council.
According to the Advocate General and her recommendations to the Court, the current EPR scheme would not be based on sufficiently reliable scientific data and would not respect the principle “the polluter pays”.
The Court’s judgment now rests on the final word in the case, and it may follow a different route from the one indicated by the Advocate General. In any case, the opinion is suggestive of a possible intervention to correct the current scheme, so as to include industrial sectors beyond pharma and cosmetics in sharing at least 80% of the costs of quaternary treatment needed to remove micro-pollutants from wastewater.
All pharmaceutical industry associations have welcomed the Advocate General’s opinion. The request is to urgently conduct a new, independent impact assessment to better consider all factors relevant to determining how to share the costs of quaternary treatment.
EFPIA underlined the remarks about serious deficiencies in the EU Commission’s methodology for calculating the toxic load, the data used for certain pharmaceutical substances, and the insufficient assessment of other potentially relevant sources of micro-pollutants. The legislature’s determination and assessment of the relevant evidence were then affected by manifest errors, wrote in its note.
Medicines for Europe called for the EU Commission to urgently pause the EPR scheme to protect the medicine supply. The scheme’s major impact on manufacturers of generic, often low-cost medicines could lead them to move production to extra-EU countries and even withdraw some products, thus undermining efforts to improve European strategic autonomy in pharmaceutical manufacturing and limiting patients’ access to essential medicines.
In its note, AESGP underlined the need for a fair, proportionate, evidence-based and environmentally effective approach. According to the association, the debate is about more than industry costs: Europe needs to improve water quality while ensuring that environmental measures do not undermine access to affordable medicines or the sustainability of healthcare systems.
https://aesgp.eu/articles/advocate-generals-opinion-strengthens-case-for-fairer-epr-under-uwwtd
The JURI Committee on the SPC extension for biosimilars
The Legal Affairs Committee (JURI) of the European Parliament voted on 8 September on extending SPCs for biological medicines that provide a therapeutic advantage to patients, as part of the Biotech Act package. A further 12 months of SPC protection may be granted, subject to new investment in multi-country European clinical research and maintaining a significant manufacturing presence in the EU.
The JURI’s text underlines the need to preserve a stable, predictable and innovation-friendly intellectual property framework that supports investment in R&D and manufacturing. Meanwhile, EU-based biosimilar manufacturers can produce and store active substances and finished medicinal products in a Member State for an unlimited period before the SPC expires, so they can enter the market from day-1. The JURI’s text also underlines the importance of supporting Europe’s industrial base and tackling the competitive disadvantage compared with producers from third countries offering less or no protection.
https://www.europarl.europa.eu/doceo/document/JURI-AD-789902_EN.pdf
While welcoming the JURI Committee’s support for stocking and launching biosimilars in Europe from day-1, Medicines for Europe expressed concern about the agreed SPC extensions, as longer monopoly rights delay competition and access to medicines.
The proposal for a Public Procurement Act
The EU Commission adopted its proposal for the Public Procurement Act on 9 September. The reform aims to make public procurement more flexible and effective, and is expected to deliver significant annual administrative savings of €650 million. A key action will consolidate the current fragmented pieces of legislation and provisions, often sector-specific, into a single regulation. This is expected to create a more coherent and predictable procurement framework, reduce complexity and administrative burden, and limit possible procedures to three.
https://single-market-economy.ec.europa.eu/document/download/59557310-3af0-426d-b6b6-0357b650065f_en
The proposal also includes creating an integrated digital procurement marketplace consisting of interconnected and interoperable Member States’ eProcurement platforms. Tenders shall consider quality, not only price, with the Best Price-Quality Ratio (BPQR) as the standard award method. Quality criteria should account for at least 30%; public buyers should also include environmental, social, innovation, security and resilience, and European preference considerations in the procedures. The proposal also contains provisions to ensure greater security of supply, resilience, and strategic autonomy in public procurement.
EFPIA recommends limiting price-only procurement to clearly defined, exceptional circumstances; criteria related to localisation should also remain exceptional, proportionate , and non-discriminatory.
As for Medicines for Europe, the MEAT criteria should serve as the standard and be mandatory to move away from price-only tendering. Multi-winner tenders and appropriate lot division could avoid market consolidation, while realistic demand forecasts, adequate lead times, and clearer volume allocation would support more predictable demand and manufacturing planning. The associations also call for stronger scrutiny of abnormally low bids to avoid price dumping, prevent accelerated market exits and favour continuity of supply.
MedTech Europe particularly welcomed the best price-quality ratio, as well as the proposed new framework that helps buyers describe the required outcome or performance. The Association of the medtech industry also underlines that the most valuable provisions contained in the Act – for example, those on value-based procurement – remain left to buyer discretion, or postponed to future implementing acts, thus leading to continued fragmentation. According to the note, attention should be paid to the concept of European preference, as medical technologies are not ordinary industrial goods: the Health sector should be exempted from these measures, or any preference should be limited to clearly defined product categories where competition is sufficient, and supply is secure. MedTech Europe also indicates that the new security and resilience provisions should be proportionate, workable and consistent with the Union’s trade commitments. In particular, requests for information should be coordinated across Europe, not left to single buyers.
