Czech health official: Longer patent protection will not boost pharma innovation

The Czech Ministry of Health says that providing longer regulatory protection, proposed by the pharma industry, will not solve the problem of the outflow of investment from Europe to the USA or boost innovative medicines, rejecting the industry’s arguments.

The European Commission’s proposal, introduced in April 2023, seeks to update the 20-year-old pharmaceutical legislation. The goal is to improve patient access to modern medicines while bolstering Europe’s standing in the global market.

The central issue lies in the intellectual property protection for new medicines, particularly the proposed reduction of Regulatory Data Protection (RDP). This includes a reduction in unconditional data protection from eight to six years, coupled with two years of market protection.

After the data protection period, the innovative company is obliged to release information to companies wishing to develop generic versions of the medicine. After the expiry of the market protection, generics can be placed on the market.

The Commission’s proposal introduces incentives for extending RDP in specific cases, such as launching medicines in all EU countries or addressing unmet medical needs.

The pharmaceutical industry argues that the proposed changes will negatively affect the research and development of new medicines in Europe.

To support their arguments, the European Federation of Pharmaceutical Industries and Associations (EFPIA) commissioned a report warning that Europe could face an outflow of investments in innovations because of the proposal.

“No equation mark”

The Czech Deputy Health Minister Jakub Dvořáček sees the situation differently. According to him, there is “no equation mark” between the setting of the length of RDP and the level of innovative drug development in the EU.

“I challenge the thesis, the narrative, that drug development and research in Europe depends on the RDP we have in place,” Dvořáček told Euractiv.

He stressed that the gap in R&D investment between the EU and the US has widened significantly over the last 15 years despite Europe’s high level of protection granted to pharmaceutical companies.

“Industry says it is necessary to keep the long RDP to motivate them to develop the drugs in Europe, but in reality, it does not work,” Dvořáček explained.

No EU “business angels”

For him, the problem primarily in the availability of venture capital, which is much higher in the USA than in Europe. According to him, there are many “business angels” in the US who are ready to significantly support the research of innovative drugs despite the risk of potential failure.

“In Europe, we are missing this aspect,” Dvořáček emphasised, adding that this concerns not only the pharmaceutical industry but also other sectors, such as IT.

Still, the industry argues that proposed cuts in RDP will make the situation in Europe even worse.

Currently, around 47% of new treatments are of the US origin, while 25% are from Europe.

EFPIA: Reducing RDP will impact drug accessibility

EFPIA study found that the proposal could cause the loss of 50 of the 225 products relying on RDP, otherwise expected to be developed from 2020-2035. Moreover, the industry says that decreasing RDP duration could also negatively affect the launch of medicines in EU member states and, therefore, the accessibility of medicines.

The pharma proposal wants to motivate the industry to launch medicines quicker across Europe with the use of incentives.

When the company launches its product in all member states in the EU, it should receive two additional years of RDP. The European Commission argues that providing longer protection for launch in all EU countries will make medicines significantly more affordable for patients across Europe.

However, the industry says they can hardly influence affordability because it also depends on the approach of national authorities.

Yet, member states are passively waiting for the decision of companies to launch the medicines in their markets, the Czech Health Ministry said. The Commission’s proposal will help change this situation and give member states the possibility to decide what medicine to accept into their health care systems.

Czechia also argues that smaller member states are particularly affected by the inaccessibility of many medicines today.

Clarification is needed

The Czech deputy health minister acknowledged that some things regarding the pharmaceutical package need to be clarified and said he was waiting for further details from the European Commission so that countries can start to deal with the package in more detail.

Dvořáček also insisted that all decision-making must keep patients and their access to medicines in mind.

“The pharmaceutical package is not here to make the generic or original industry happy,” Dvořáček told Euractiv, adding that the new legislation is “for patients and if it makes the industry sleep well, it is only a coincidence”.

[By Aneta Zachová, edited by Vasiliki Angouridi | Euractiv.com]

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