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Czech MPs concerned over EU pharma package marketing protection changes

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The debate over the EU pharmaceutical package is currently in full swing in the Czech Republic, with discussions among lawmakers revealing that the proposed changes to data and marketing protection are raising remarkable concerns.

The new EU pharmaceutical package, presented in April 2023, is considered a significant milestone in realising the European Health Union.

In October, the Czech Senate’s Health Committee expressed its concern about the European pharmaceutical package, warning that it could discourage manufacturers from the EU market.

Czech lawmakers from the upper chamber of the Czech parliament emphasised that the pharmaceutical industry is a high-tech sector with one of the highest added value per person employed and one of the highest ratios of research and development investment to sales.

“Stable and predictable regulatory framework and the provision of intellectual property protection are key to maintaining Europe as an attractive location for research, development and manufacturing of medicines,” Czech senators stated.

In this context, they warned that some of the measures included in the EU pharmaceutical package “threaten the stability, predictability and attractiveness of this framework”.

In particular, they mentioned the setting of conditions for the duration of regulatory data protection in the draft directive or market exclusivity in the draft regulation.

Currently, there is a ten-year period of protection. This period includes eight years of data protection, ensuring that pharmaceutical companies have exclusive rights to their research data for a specific time, and preventing competitors from using it to gain approval for similar products.

After this period, an additional two years of marketing protection prevent generic versions from being sold in the EU market. For orphan drugs (medicines for rare diseases), the maximum regulatory protection period is ten years.

The European Commission’s proposal of a new pharma directive envisages a minimum period of regulatory protection of eight years consisting of six years of data protection and two years of market protection.

This period can be extended in particular cases – if medicines are launched in all EU countries (+2 years), if they address unmet medical needs (+6 months) or if comparative clinical trials are conducted (+6 months).

For rare disease medicines, the standard duration of market exclusivity will be nine years. Additional years of protection will be applied if companies address a high unmet medical need (+1 year), launch the medicine in all EU states (+ 1 year), or develop new indications for an already authorised orphan medicine (up to 2 extra years).  

For the Czech Senate’s Health Committee, this new proposal is unacceptable.

The committee, therefore, recommended that the government should not support any proposal that could weaken intellectual property protection.

The committee chair, Roman Kraus (ODS, ECR), told Euractiv that he fully shared his committee’s opinion. On the other hand, the Commission’s proposal also has its supporters among Czech senators.

“Contrary to the opinion adopted by the Senate Health Committee, I do not see the efforts to reduce the period of regulatory data protection for medicinal products from eight to six years when introducing a new incentive system for the pharmaceutical industry as such a fundamental weakening of intellectual property protection that would threaten the stability of the market and thus ultimately the availability of medicinal products,” Senator and oncologist Karel Zitterbart (independent) told Euractiv.

“Rather, I assume that countries like the Czech Republic, or more precisely Czech patients, would benefit from the proposed conditional regulatory protection,” he added.

The pharmaceutical package was also discussed at the EU affairs committee of the Czech Chamber of Deputies – the lower chamber of parliament.

However, its conclusion was not as negative as the Senate’s. The EU committee called for clarification on reducing a medicinal product’s regulatory data protection period and its potential impacts.

The Czech government voiced a similar view, broadly welcoming the revision of EU pharmaceutical legislation.

However, it pointed out that a clear position cannot yet be taken on the changes in regulatory data protection, as some aspects will need to be clarified.

According to the European Commission, the current legal framework fails to address several critical issues, including unmet patient treatment needs, medicine affordability, unequal access to medicines within the EU, growing medication shortages, and a lack of motivation for innovation.

Besides regulatory and market protection changes, the package envisages quicker evaluation and authorisation processes and simplification of procedures.

(Aneta Zachová – Edited by Vasiliki Angouridi/Zoran Radosavljevic)

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