Decrease in data protection period risks medicine price increase, says Greek health minister

The Greek government is firmly opposed to any changes to the duration of the regulatory protection period (RDP) in the EU Pharma Package, with Health Minister Adonis Georgiadis pointing to negative consequences for Europe and Greece, as the file moves from Parliament to Council.

On 10 April, the European Parliament adopted its position on the Pharma Package. The Parliament plans to revisit the legislation after the 6-9 June European elections, when the new legislative framework moves to the European Council before final negotiations with the Commission and Parliament.

The Package has been criticised for its inability to meet its preset goals of “fostering innovation, ensuring the security of supply, accessibility and affordability of medicines.”

Athens shares these concerns, specifically on the consequences of any change to the RDP.

Euractiv spoke with Greek Health Minister, Adonis Georgiadis on the sidelines of the Delphi Economic Forum (10-13 April), where he clarified that the Greek government wants to maintain the RDP framework as it is currently, stressing: “We do not want a change, either up or down.”

Reduction of RDP equals price increase

“The European Commission’s proposal asks for a reduction to RDP by two years, which could be increased through certain incentives. We fear that such a policy, in reality, will lead to two significant losses,” Georgiadis told Euractiv, explaining why Athens firmly stands for keeping baseline RDP at eight years.

“First, it would discourage many international companies from developing innovative products in Europe. And second, and most importantly for us, if you reduce the years of protection, the price will increase accordingly.”

According to Georgiadis, in reality, poorer countries, like Greece, would have limited access to innovative medicines within the protection period and, in addition, “when the pharmaceutical product would lose its protection because generics are priced at a percentage of the reference medicine’s price, you would still have a higher price of the generics for several years.”

“Even though at first glance it looks like such a move would favour the poorer [member states] more than the richer, in reality, the exact opposite will happen,” he added.

‘A positive development‘

Hellenic Association of Pharmaceutical Companies (SFEE) President and Novo Nordisk Hellas General Manager, Olympios Papadimitriou, shares the government’s worries.

“A shift for the worse to the incentives for the protection of intellectual property will have serious consequences for the whole of Europe and especially for Greece as a smaller country,” he told Euractiv at the Delphi Forum.

“So, the fact that the Greek government, through its Health Minister, is committed to preserving the current RDP status is a positive development, one which we hope will prevail in the shaping of the new EU pharma legislation,” he added.

According to Papadimitriou, it would help both retain a high level of investment in Research and Development in Europe and, therefore, in Greece and ensure patient access to new, innovative medicine.

“The pharmaceutical industry is a lever of growth in the EU, and maintaining competitiveness in relation to pharmaceutical innovation is a sign of insightfulness for the future. Because we talk about people’s lives, for ensuring innovative medicine reach those who need them,” Yvonni Papastelatou Sanofi Country Lead Greece & Cyprus, said during a panel discussion at the Forum.

“As it is widely recognised, health is an investment and not an expenditure. Europe’s health autonomy should be on the agenda and raised to the level of importance of food and energy autonomy,” she added.

Greece, a distinctive case

When it comes to pharmaceutical policies, Greece is also dealing with national policy headaches.

Clawbacks and rebates have been rapidly growing, accounting for 50% of the total reimbursed market in 2023, which increased 19% year-on-year in the last six years. Between 2012 and 2023, public pharmaceutical funding decreased by 23%, while the pharma market grew by 65%.

“Our country has a distinctiveness because it needs to improve its ‘local stance’ towards innovation,” Papadimitriou told Euractiv.

“The immense returns are a very serious issue that has developed negative bias. The problem is enhanced by a system characterised by instability and low predictability. We learn things after the fact, we are called upon to apply decisions retrospectively, and we result in ‘accounting alchemies’ that have to do more with the past and present and much less with the future. Basically, it’s not easy to plan what’s coming,” he explained.

However, according to Papadimitriou, companies are generally trying to be active and invest, especially in clinical trials.

“Production activities for international companies are very complex decisions. But in the field of clinical studies, we are making significant moves. Just one example I can provide from our company [Novo Nordisk]: in the last few years, we have almost doubled our activities in clinical trials. That could be better incentivised, but unfortunately, it is not foreseen at the moment,” he added.

[By Vasiliki Angouridi, Edited by Brian Maguire | Euractiv’s Advocacy Lab]

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