EFPIA Warns Limited SPC Reform Could Weaken EU Pharma Competitiveness

The European Federation of Pharmaceutical Industries and Associations ( EFPIA ) has published its position on the Biotechnology Law, which includes an impact assessment of the European Commission ‘s proposals to extend the Supplementary Protection Certificate (SPC) for another twelve months.

EFPIA’s document, prepared by Copenhagen Economics, analyzed the costs and benefits of this measure for the economy, patients, and healthcare systems. The industry association outlined its position as the European Parliament works on the aforementioned law, which it described as a positive step for competitiveness, although it warned that the limited scope of the current proposal restricts its potential impact.

EFPIA urges broader SPC extension to boost investment and innovation

EFPIA’s analysis indicated that expanding the scope and eligibility criteria of the SPC would allow the European Union to register over €45 billion in incoming investment. Furthermore, this regulatory change would facilitate the creation of up to 24,500 new clinical trial slots over a 15-year period.

According to the research presented, the intellectual property offering within the EU currently lags behind that of the United States, the United Kingdom, and Switzerland, and is only slightly ahead of China. Therefore, the current proposal is unlikely to alter companies’ investment decisions.

EFPIA’s research assessed the impact on patient access to new medicines, the value to healthcare systems, and the contributions to employment. These factors were compared with the costs associated with the increased healthcare spending resulting from the delayed introduction of generic and biosimilar medicines. Data collected across eight different scenarios demonstrated that reach and eligibility are the main drivers of benefits, while a longer duration represents the central cost factor for public administrations.

Effects on drug availability

EFPIA’s report suggested that Europe can maximize the effectiveness of the SPC extension through a broad approach and flexible criteria, while maintaining a minimum extension of twelve months. With this modification, up to 27 new medicines per year would be eligible, compared to the two included in the European Commission’s current proposal.

In the regulatory body’s baseline scenario, an additional 2,200 patients are estimated to be enrolled in clinical trials, and two innovative molecules are expected to be launched over 15 years. In contrast, the more flexible approach would raise the figure to 24,500 patients and 18 new drugs developed within the European Union.

The difference between the scenarios analyzed showed a tenfold increase in research and development investment in the broader projections compared to the more restrictive ones. For twelve-month extensions, the ranges were between €4 billion and €45 billion, while for twenty-four-month periods, the range was between €8 billion and €90 billion. Six of the eight scenarios evaluated generated a positive return on investment for the European economy and maintained a limited impact on pharmaceutical spending .

A 12-month extension of the Special Provision for Pharmaceuticals (SPC) for biologics with limited eligibility increased healthcare spending by 0.003% and drug spending by 0.02%. The proposal to extend the scope to all compounds raised the estimated impact to 0.07% of healthcare spending and 0.5% of drug spending.

EFPIA’s report indicated that only in the broadest scenario, which envisions a 24-month extension for all molecules, did the budget increase reach 1%. The pharmaceutical industry association asserted that cost-benefit evidence supports the conclusion that only significant flexibility will drive the discovery and manufacturing of next-generation vaccines and treatments.

Competitiveness in the global market

The pharmaceutical industry expressed its full support for the Biotechnology Act, particularly regarding the harmonization and reduction of clinical trial timelines, as well as the pursuit of a coherent regulatory framework. However, it cautioned that the legislation and the extension of the Special Protection Certificate (SPC) alone will be insufficient to compete on a level playing field with the United States and China. EFPIA’s leadership emphasized that EU benefits risk being jeopardized if a restrictive approach to intellectual property is adopted.

Nathalie Moll, Director General of EFPIA, stated that, “as global competition increases, every research project conducted elsewhere represents a missed opportunity for European patients, investment, skilled jobs, and future growth.” Moll concluded that Europe “cannot afford to allow the world’s most innovative drug research to be conducted outside the continent, as this would run completely counter to the recommendations in the 2024 Draghi Report.”

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(Featured image by CDC via Unsplash)

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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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