The Czech Republic has put forward a proposal that could provide valuable incentives to pharma companies while promoting research and production in Europe.

EU member state representatives will meet on Monday (21 October) in the Working Group on Pharmaceutical Products and Medical Devices to discuss how they can overcome the impasse on incentives in the pharma package. 

Opinion is sharply divided between those who are worried that the Commission’s proposal would weaken incentives for medical innovation and those who welcome a system that could potentially speed up access to more affordable products, by reducing regulatory data protection (RDP) periods. 

Hungary will put forward a proposal, but part of a potential solution has been presented by the Czech government. 

“Our proposal was sent to our colleagues in the Hungarian Presidency of the EU Council in September. The section on production may be the most controversial, but no one has rejected it,” said Deputy Minister of Health Jakub Dvořáček in response to a question from Euractiv.

Supporting EU R&D
Prague aims to modify the proposed system of additional regulatory data protection periods to incentivise research and production in the EU. The requirement would be for “a substantial part of research”, say 30% of patients involved in phase II and phase III clinical trials to be from the EU. This would be rewarded with an additional six months of data protection.
Production in the EU
The second part of the Czech proposal is to reward manufacturing within the EU intended for the benefit of European patients with an additional year of regulatory data protection. They attach two conditions to this proposal. Eligible manufacturing capacities should have the capacity to cover the needs of the entire EU market and should be able to start production no later than three years after the market authorisation. 

With this approach, the Czech Republic aims to put an end to the significant transfer of research, development, and manufacturing of medicinal products to other countries outside the EU, such as the United States.

The current proposal provides for six years of regulatory data protection (RDP), a reduction from eight in the current legislation, during which other companies cannot access product data. In the new proposal this can be extended if a product is supplied to all EU states simultaneously (+ 2 years), addresses an unmet medical need (+ 6 months), has a relevant comparator in a clinical trial – to compare effectiveness against an existing treatment (+ 6 months) or there is an additional therapeutic indication found (+ 1 year).

Shared benefits
Dvořáček argues that linking incentives for manufacturing products within the EU would be a way to recuperate costs. Tying incentives to manufacture of medicinal products within the EU represents a way of recouping some costs. 

In the Czech Republic alone, which has a population of around ten million, each additional year of protection for a medicine is estimated to cost almost €126 million from the public health insurance budget. It also means that the availability of innovative treatments is limited for an estimated 20,000 patients. That estimate is for Czechia alone, the minister says that extended across Europe then the benefits would be much higher.

Dvořáček acknowledges that much of the growth in manufacturing he foresees would be in Germany, Spain, France, Belgium and elsewhere, nevertheless, he says that all countries would benefit and that it would benefit Europe as a whole.

[Edited by Catherine Feore]