The European Union’s pharmaceutical reforms must maintain the current patent protection baseline, says David Kolář, executive director of the Czech Association of Innovative Pharmaceutical Industry. Kolář spoke in-depth with Euractiv’s Aneta Zachová.
He told Euractiv that the current proposals risk undermining innovation and driving investment away from Europe.
AZ: Negotiations about the EU pharma package are ongoing. How do you assess the process so far?
DK: Before the pharmaceutical legislation revision, the European Commission published a pharmaceutical strategy, partly in reaction to the COVID-19 pandemic. The strategy included some very interesting elements, offering a fresh perspective that was welcomed by the innovative pharmaceutical industry.
However, the European Commission then published the legislative proposal.
When we saw the first draft, it became apparent that it did not include ideas previously outlined in the strategy. It seemed that the strategy was drafted by different people than the legislation.
If the strategy aimed to make Europe more self-sufficient and attractive for innovation, as outlined in the preamble, it is unclear how this would be achieved while simultaneously shortening patent protection periods, adding administrative obligations, and addressing pressing issues like supply shortages merely through reporting systems – as was suggested in the Commission’s proposal.
Frankly, the original draft of the legislation was disappointing. If passed in its original form, it would fail to address the outlined challenges and could even worsen the erosion of the sector.
AZ: The European Parliament published its position in April 2024. From your perspective, is it better than the original proposal?
DK: The European Parliament’s position is closer to a compromise. At the EU level, compromises are the norm, ensuring that all sides are somewhat satisfied.
While the Parliament’s version is significantly better than the Commission’s, it is still worse than the current status quo.
For example, the European Parliament wants, as well as the European Commission, to shorten the baseline regulatory data protection compared to the current state. Reducing protections fundamental to how innovative companies operate does not align with the goal of making Europe more attractive.
AZ: What about the member states’ position? The Czech Health Ministry recently introduced a compromise proposal, suggesting some incentives for pharmaceutical companies. What do you think about this Czech initiative?
DK: The Czech Health Ministry has been active in negotiations since the start, particularly during the Czech Presidency in the Council of the EU (second half of 2022). It is quite interesting that it has proposed a compromise, as this should be the role of Hungary, which is holding the EU presidency now.
The Czech proposal leans against innovation.
Traditionally, the Czech Republic has strongly supported patent protection, so this shift is somewhat surprising. The proposal includes incentives for additional protection periods under specific conditions, which could be a step in the right direction. However, the six-year baseline of regulatory data protection remains too short, making these incentives insufficient to offset the reduced protection period.
Without raising the baseline to at least eight years, these additional incentives are unlikely to make a significant difference.
AZ: So, do you not see any meaningful impact from these additional incentives?
DK: Not really. Companies make decisions based on predictable, guaranteed elements, like the baseline protection period. Incentives are nice, but they don’t provide the certainty required for long-term investments.
Given the time it takes to develop a drug—12 to 15 years—it’s impossible to rely solely on additional incentives when deciding where to invest resources.
AZ: Besides the protection period, is there anything else in the pharmaceutical package that could influence European research and development investments?
DK: There are many smaller regulatory and technical elements. For instance, simplifying the European Medicines Agency’s approval process, which is currently the slowest among major regions, would be a clear improvement.
However, other aspects, such as environmental requirements for drug production, could create challenges. Overall, the key to fostering investment remains intellectual property protections and related tools.
AZ: Competitiveness is a major theme for the EU, especially following the European Parliament elections. Do you think this focus could influence the pharmaceutical package discussions and encourage better provisions for the industry?
DK: I hope so. However, there is always the risk of it becoming just rhetoric, similar to the pharmaceutical strategy. The strategy outlined an excellent plan, but the execution went in the opposite direction.
If Europe genuinely prioritises competitiveness, aligns with reports like the Draghi Report, and adopts evidence-based policies, it could regain its momentum.
Unfortunately, European institutions often address problems with new regulations, adding layers of obligations without considering how industries operate. A truly motivational incentive structure is needed.
AZ: Do you feel that EU institutions adequately consider stakeholders’ feedback?
DK: Not sufficiently. For example, patient organisations like EURORDIS have expressed dissatisfaction with how incentives for orphan drugs are structured, and many of their recommendations to the Commission were ignored. While consultations exist, the outcomes do not always reflect the feedback provided.
AZ: Lastly, what are the strengths of the Czech innovative pharmaceutical industry?
DK: The Czech industry excels in fostering constructive dialogue at the national level. It actively participates in working groups and discussions on key topics, engaging with health insurers, the State Institute for Drug Control, and the Ministry of Health.
Moreover, the Czech Republic has a strong clinical trials sector, which benefits patients and saves significant healthcare costs. Shared service centres established here, such as IT and financial hubs for multinational companies, also highlight the country’s potential as an attractive base for global operations.
AZ: Where do you see room for improvement?
DK: The Czech Republic lacks manufacturing capacities for innovative drugs. Addressing this would require the state to create more favourable conditions, such as expediting construction permits, improving infrastructure, or increasing the number of professionals who can actively work in the pharmaceutical industry.
Additionally, strengthening clinical trial infrastructure and leveraging the country’s appeal for high-value shared service centres could further boost the sector. Developing these areas could significantly enhance the Czech Republic’s position in the innovative pharmaceutical industry.
[Edited by Vasiliki Angouridi, Brian Maguire]
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Publish date : 2024-11-17 17:41:00
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