Euro Roundup: Romanian Senate pushes back against EU plans to change duration of market exclusivity

The Romanian Senate has asked the European Union to drop its plans to change the duration of market exclusivity as part of the proposed reform of the pharmaceutical legislation. Members of the upper house of the Parliament of Romania expressed their objections to the reform proposals in a recent letter to the president of the Council of the European Union.

The senators have recommended that the EU revise plans to incentivize companies to launch products in all member states within two years of obtaining marketing authorization. Instead of shortening market exclusivity by two years unless they make a drug available in all member states, as the EU is proposing, the senators recommend keeping the current exclusivity period.

As an alternative incentive, the senators recommend that companies that file for reimbursement within two years of approval should gain exclusivity beyond the current 10 years. The letter also calls for member states to commit to a 180-day deadline for completing the price approval and reimbursement process and for the European Commission to require EU countries “to have a continuously updated database to monitor access to innovative medicinal products that address unmet medical needs.”

The Romanian officials shared a second set of recommendations related to the duration of market exclusivity for orphan drugs, arguing that any change to the current 10-year period should be “upwards, not downwards, with additional benefits for medicinal products that address unmet medical needs.” The senators also proposed the creation of a forum where patients, industry and healthcare professionals can work to “identify a flexible and pragmatic formula for assessing unmet medical needs.”

In other sections of the letter, the Romanian officials advise the Commission to assess the impact of the proposals on the competitiveness of the pharma industry and state that the reforms “do not comply with the proportionality principle.” The EU pharma industry has repeatedly called out the Commission for failing to include an impact assessment in its proposals.

Senate Letter

European Parliament committees vote in favor of creating European Health Data Space

Two European Parliament committees have voted to create the European Health Data Space (EHDS). The committees voted to add opt-in and opt-out mechanisms, advancing changes to the original plan that have raised concerns at trade groups.

EHDS would give patients access to their personal health data and allow healthcare professionals to view data on their patients. EFPIA and MedTech Europe, trade groups representing the EU pharma and medtech industries, have criticized elements proposed in debates on the law, warning that “any form of opt-in or opt-out mechanism would introduce the real risk that data bias will form part of the EHDS.” (RELATED: EFPIA calls for harmonization to improve access to digital therapeutics, Regulatory Focus, 08 June 2023)

The Committee on Environment, Public Health and Food Safety, plus its civil liberties equivalent, voted by 95 to 18, with 10 abstentions, in favor of plans to add opt-in and opt-out mechanisms. The Parliament described the draft position established by the committees as “data-sharing for the common good with safeguards.”

“In their draft position, MEPs want to make explicit permission by patients mandatory for the secondary use of certain sensitive health data and provide for an opt-out mechanism for other data. They also want to give citizens the right to challenge a decision of a health data access body and allow non-profit organizations to lodge complaints on their behalf,” the Parliament wrote in a statement.

Other proposed changes include expanding the list of cases in which the secondary use of data would be banned. The European Commission’s original proposal supported the use of data for reasons such as patient safety and policymaking while prohibiting its application to advertising. The draft Parliament report bans more data uses, including in the labor market or for financial services.

“It would ensure that all EU countries receive sufficient funding to provide protections for the secondary use of data and protect data falling under intellectual property rights or constituting trade secrets,” the Parliament wrote.

The vote positions the full house of the European Parliament to vote on the draft position the committees took in December. The Parliament also needs to reach an agreement with the Council of the EU.

Press Release

Failure of active monitoring to improve submission predictability ‘very disappointing’: EMA

Active monitoring of marketing authorization applications (MAAs) has failed to improve the predictability of initial submissions, according to the European Medicines Agency (EMA). The head of the therapeutic areas department at EMA shared the news in a presentation that called the finding “very disappointing.”

At EMA’s previous four industry stakeholder platform meetings, presenters shared data highlighting the poor predictability of initial MAA submissions. The situation led to the formation of a focus group in 2022. The group was established to perform a root cause analysis of the reasons for the delay and to propose solutions.

In December 2022, the group contacted all applicants who indicated they planned to submit an MAA in 2023 to confirm their plans and the exact date of submission. Every quarter, the group checked the planned submissions against the received filings and asked applicants who missed their targets to explain why.

As Francesca Day, head of the therapeutic areas department at EMA, explained in a presentation at the latest industry stakeholder platform meeting, active monitoring was supposed to deter multiple changes in the submission date. However, less than half of submissions arrived on time across the first three quarters of 2023.

Day’s presentation concluded that overall, “it is very disappointing that active monitoring seems not to have had any effect on submission predictability.” Another focus group meeting is scheduled for January when the members will look at the data in more detail and “discuss more active measures, since passive ones [are] not working.”

EMA Presentation

EDQM survey finds a lack of awareness of medical device falsification at most levels

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has found that efforts to tackle counterfeit medical devices are being held back by “a lack of awareness of the problem of falsification at most levels.”

EDQM sees device falsification as “a serious international matter of concern” but identified a lack of data on the situation. To address the data gap, EDQM’s falsification committee surveyed European authorities about how they perceive and address the problem. EDQM published the survey findings this week, noting problems related to “a lack of understanding of the nature of medical devices.”

The survey found few investigations into falsified medical devices, particularly at a criminal level, and even fewer prosecutions. EDQM also called out the lack of data collection and exchange of information. It is unclear at this early stage if the new EU medtech regulations are helping to address the falsification of medical devices, EDQM said.

EDQM Notice

Other news:

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has shared its review of the safety data for valproate and has begun to prepare healthcare providers for the imposition of new rules in January. MHRA Review, More

Euro Roundup: Romanian Senate pushes back against EU plans to change duration of market exclusivity

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