ENVI’s EU pharma package ‘a bloody compromise’ says Czech shadow rapporteur [Advocacy Lab Content]

The European Parliament will vote on Wednesday (10 April) on the new pharmaceutical legislation, which the shadow rapporteur Kateřina Konečná (The Left) calls “a bloody compromise”, while Czech MEP Ondřej Knotek welcomed the ENVI outcome.

The new legislation aims to improve the availability of medicines, enhance the security of supplies and offer an innovation-friendly environment for research, development and production of medicines in Europe.

In mid-March, the European Parliament’s ENVI committee voted on draft reports of both legislations, which are now expected to be voted on in the plenary session on April 10.

“I was the shadow rapporteur for both the directive and the regulation, and I must say that these were very difficult negotiations, both mentally and in terms of time, and the bloody compromise that was voted in the ENVI committee corresponds to this,” MEP Konečná told Euractiv.

Negotiations in the ENVI committee took less than a year at an “absolutely frantic pace”, the Czech MEP explained.

“Given the scale of the whole package, everyone will find something positive and negative in it,” Konečná added.

Regulatory data protection remains controversial

One of the most pressing issues was the length of patent protection for drug manufacturers.

While the European Commission originally proposed a six-year regulatory data protection (RDP) period, the ENVI committee wants to prolong it to seven and a half years. The additional market protection, during which generic, hybrid or biosimilar products cannot be sold, should take two years.

Companies should also be eligible for ‘bonus’ years of RDP if their products address unmet medical needs if the product’s research and development takes place in the EU, or if comparative clinical trials are conducted for the product.

The ENVI report also favoured a cap on the RDP period of eight and a half years.

“I am afraid that the seven and a half years are actually only hypothetical in this system and, given the soft bonus system – the comparative studies, etc. – virtually every company will reach the maximum ceiling,” Konečná warned.

The Czech MEP argues that longer patent protection will not stimulate the development of innovative medicines in the EU as the draft report envisages.

“For me, the better way to go is certainly through public funding and maximum transparency and conditionality of that funding, just either with the return of industry to the EU or better access to medicines,” Konečná explained.

Another Czech MEP, Ondřej Knotek (Renew), praises the draft report and, as a substitute member, he welcomes the ENVI compromise.

“We can be satisfied with the form of the text. It contains measures that will improve the availability of medicines to patients,” Knotek told Euractiv.

He is also convinced about the positive impact of the legislation on drug development in Europe.

“The development of new innovative medicines will be motivated by additional protection if, for example, the medicine is developed in the EU in collaboration with the public sector or responds to patient needs not yet covered by medicines,” Knotek explained.

“In contrast, generic drug manufacturers will be given the opportunity to launch a drug immediately after the protection of the original protected drug expires,” he added.

Better access to transformative therapies

Knotek highlighted that the report addresses transformative therapies, such as cell and gene therapies.

Under the new law, a special task force should be established under the European Medicines Agency (EMA) to focus on the availability of transformative therapies for rare diseases. “The report also facilitates cross-border access to these therapies,” Knotek emphasised.

Konečná sees some positive aspects of the drafted text. She is particularly pleased that the ENVI committee approved her amendment, introducing the possibility for member states to ask the European Commission to purchase specific orphan medicines in bulk.

“When I wrote and negotiated this proposal, I was aiming primarily at highly innovative and expensive medicines. Only if we join forces and buy together will we bring the price down, buy more of these medicines and provide them to more patients,” she said.

She also supports the obligation of pharmaceutical companies to submit a pricing and reimbursement request in all EU Member States.

“I will probably support the Regulation in plenary,” Konečná revealed. However, her support of the Directive which sets up the patent protection is still undecided.

The April vote on the report marks the conclusion of the current mandate’s efforts regarding pharmaceutical legislation. The task of continuing negotiations with EU member states and the Commission on the final text of the legislation will be handed over to the incoming mandate, set to be determined by the European elections in June 2024.

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

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