The long-awaited Biotech Act will focus on sector financing, clinical trials and incentives for the industry, Euractiv has learned, with the latter already sparking fresh debate.
On Tuesday, the Commission is set to present the first part of the Biotech Act. In the version seen by Euractiv, that would extend the supplementary protection certificate (SPC) for medicines developed using biotechnological processes by 12 months.
According to the latest version, advanced therapy medicinal products (ATMPs) would also be granted an additional year of protection. The provision – supported by the innovative industry – is intended to encourage the development and manufacture of such products within the EU.
That proposal confirms rumours that Adrian Hoven, director general of the generics industry association Medicines for Europe, addressed in an interview with Euractiv on Monday. He warned that, according to the organisation’s calculations, extending additional intellectual property protection to biological medicines would cost health systems around €7.7 billion for the top three biologics alone.
“The SPC is, in many cases, the last protection clause available and therefore one of the most crucial for effectively extending intellectual property rights,” a person close to the file told Euractiv. “The budgetary impact for national health systems would be significant.”
However, the issue of extending the supplementary protection certificate could still be somewhat revised ahead of the presentation of the text, scheduled for Tuesday afternoon in Strasbourg. Otherwise, it will most likely spark a long-lasting debate about incentives, just as the Pharma Package did.
The Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SME (DG GROW) considers that the SPC, which is closely linked to intellectual property rights, falls within its remit and is therefore putting pressure on DG SANTE, the health and food safety directorate-general, to remove this reference from the text. A meeting between the two departments is due to take place today.
Speeding up Clinical trials
In addition, the Biotech Act is expected to address the issue of clinical trials.
The text could propose reducing authorisation timelines for multinational clinical trials from 106 to 75 days.
Where no request for additional information is addressed to the sponsor by the authority assessing the dossier – thereby putting the procedure on hold – the timelines for initial clinical trial authorisations would be reduced from 75 to 47 days between submission and decision.
In addition, the text could reduce the evaluation period for advanced therapy medicinal products (ATMPs) from 96 to 47 days, given the growing scientific and regulatory expertise in this field.
If there’s no request for additional information addressed to the sponsor, the timelines for assessing substantial modifications would be reduced from 64 to 33 days between submission and decision.
The EU Capital booster pilot
The text is expected to propose a European investment facility for health biotechnology through the European Investment Bank, and also with “other implementing partners.” This approach would combine equity financing with debt instruments such as venture capital.
Moreover, advanced-stage health biotechnology projects integrated into an EU Capital Booster Pilot – a pilot scheme designed to strengthen the capacity of innovative companies to raise private capital, in particular on capital markets – will be recognised by the Commission as strategic, high-impact projects.
A comprehensive analysis of the EU’s biotechnology landscape would also be conducted to identify strengths, gaps, dependencies, and areas requiring investment. This approach would enable guidance on the selection and prioritisation of strategic, high-impact projects as well as on shaping EU policies and funding allocations.
In parallel, a European health biotechnology support network would be set up. It would consist of national and regional contact points tasked with helping biotechnology projects. It would also support innovators in navigating regulatory procedures, accessing funding, developing their businesses and collaborating.
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