The Czech Republic has voiced broad support for the European Commission’s proposed Biotech Act, while making clear it will push for significant changes before the legislation is finalised.
The proposal, spearheaded by EU Health Commissioner Olivér Várhelyi, is intended to strengthen Europe’s life sciences sector, revive clinical trials and accelerate the rollout of innovative therapies. As Euractiv reported, the Commission is pushing to fast-track the file, warning the EU risks losing ground to the United States and China.
“We positively note the effort to strengthen the European biotechnology sector, improve the transfer of research and development results into practice, and create a more favourable environment for innovation, investment, and manufacturing in the EU,” Renata Povolná, spokesperson for the Czech health ministry, told Euractiv.
Prague is particularly enthusiastic about provisions that could accelerate patient access to new treatments. Povolná highlighted measures aimed at simplifying and harmonising regulatory procedures, supporting clinical research, developing biosimilar medicines, and expanding the use of data and artificial intelligence as priorities that the Czech Republic views favourably.
“No” to new burdens
But Czech support remains conditional. “We consider it important that the final form of the proposal does not lead to a disproportionate increase in the administrative burden and takes into account the varying levels of development of biotechnology ecosystems in individual Member States,” Povolná explained.
Prague’s objections concern the Commission’s proposal to cut authorisation timelines for multinational clinical trials from 75 to 47 days in straightforward cases, and from 106 to 76 days where additional information is requested.
While Prague supports streamlining procedures, it draws a firm line on safeguards. “We support the effort to make processes more efficient, but we insist that acceleration must not come at the expense of the quality of assessment, patient protection, and member states’ competences in safety evaluation,” Povolná said.
Czech officials have also called for greater clarity on data protection provisions, warning that the current wording could limit member states’ ability to uphold stricter standards for handling sensitive health data.
Concerns over the strategic project scheme
The Act introduces a “strategic project” designation for high-impact biotech initiatives – such as centres of excellence for advanced therapies, biodefence projects, and data accelerators – which would benefit from fast-tracked regulatory support and improved access to EU funding.
Prague welcomes the concept but remains cautious about its implementation. “We consider it necessary to define the evaluation criteria more precisely so that the system does not end up being advantageous only for states with already strongly developed industrial and investment bases,” Povolná said.
In general, Prague supports the ambition outlined in the Act, but insists the final text must strike the right balance. “The Czech Republic supports the objective of strengthening biotechnology and biomanufacturing in the EU, but will seek adjustments that ensure a high level of health and safety protection, legal certainty, and practical feasibility,” noted Povolná.
[VA, BM]
Source:
www.euractiv.com