Inside EU Health: Biotech Act; transparency; professional qualifications; hantavirus antiviral
Commission estimates the cost of Biotech Act protections; Cancer Leagues call for update on pricing transparency rules; Commission calls out eight countries for failure to transpose health qualification rules; EU receives hantavirus antiviral from Japan
Commission estimates the cost of Biotech Act protections at €210 million per year
The European Commission has (finally) published a Staff Working Document supporting the proposed Biotech Act, including controversial plans to offer a 12-month Supplementary Protection Certificate extension to highly innovative medicines if they conduct late-stage clinical trials in at least two EU countries and carry out part of their manufacturing within the EU.
The Commission argues that the measure would strengthen Europe’s biotechnology sector and encourage investment at a time of growing competition from China and the United States.
Officials estimate that each additional year of protection would cost public healthcare payers around €70 million per medicine, or approximately €210 million annually if applied to three medicines each year. Delaying biosimilar competition could also reduce patient access to cheaper treatments, creating an estimated annual “patient monetized loss” of €405 million.
Generic and biosimilar manufacturers oppose the proposal, arguing that extended protections have failed to attract substantial EU-based research investment. The debate underscores tensions between rewarding innovation and ensuring access to medicines.
Catherine Feore
Cancer Leagues call for overhaul of EU drug pricing transparency rules
The Association of European Cancer Leagues (ECL) is calling for a major revision of the EU’s Transparency Directive, arguing that the 1989 legislation no longer reflects today’s pharmaceutical market.
In its report ‘Behind the Price Tag’, the organisation highlights how confidential pricing agreements, lengthy reimbursement procedures for generics and biosimilars, and the growing use of Managed Entry Agreements (MEAs) have created a lack of transparency in medicine pricing.
The ECL says this particularly affects smaller and lower-income EU countries, though wealthier states also face delays in patient access to innovative therapies. The report revisits the failed 2012 attempt to revise the directive and presents five recommendations, including greater price transparency, stricter rules for MEAs, faster approval timelines for generics and biosimilars, improved public communication, and stronger evidence standards in reimbursement decisions.
Catherine Feore
Commission calls out eight countries for failure to transpose professional health rules
The European Commission has launched infringement procedures against eight EU member states for failing to fully transpose updated EU rules on the recognition of professional qualifications in the health sector.
Letters of formal notice were sent to Denmark, Germany, Greece, Croatia, Cyprus, Malta, Austria and Portugal after they missed the 4 March 2026 deadline to incorporate Directive 2024/782 on minimum training requirements for the professions of nurse responsible for general care, dental practitioner and pharmacist, into national law.
The revised rules are intended to modernise healthcare education across the EU and reflect advances in science and technology. New or expanded training requirements cover areas including e-health, digital technologies, immunology, regenerative medicine, biotechnology, genetics and pharmacogenomics.
The Commission said the changes are designed to ensure healthcare professionals are equipped with skills relevant to increasingly digital and specialised healthcare systems. The directive also aims to support the automatic recognition of professional qualifications across member states, facilitating mobility for healthcare workers within the EU.
The eight countries now have two months to respond to the Commission.
EU receives emergency deliveries of experimental Hantavirus antiviral from Japan
The Commission has announced that it has received the first doses of an experimental antiviral for Hantavirus. The doses are being dispatched to France, Spain and the Netherlands to treat patients or run clinical trials. The European Medicine Agency identified Favipiravir as the most plausible candidate for use under clinical trial or compassionate use protocols.
Fujifilm Pharmaceuticals in Japan donated 1,400 tablets of Favipiravir to the EU. Commissioner Lahbib said it showed the value of trusted global partnerships.
The Commission is launching emergency procurement procedures to ensure availability of additional doses in case further cases are confirmed.