“A solution is needed for achieving balance between the protection of intellectual property rights, universal access to medicines, and opportunities for different companies to produce them,” stated Edmunds Cepurītis, Chair of the Saeima European Affairs Committee, on Wednesday, 10 April.

The Committee adopted the national position prepared by the Ministry of Health on the proposed revision of the European Union (EU) pharmaceutical legislation, which would provide for more flexible EU rules governing the circulation of medicinal products, ease the administrative burden, and boost the efficiency of competent authorities.

The changes propose a simplified authorisation procedure for generic and biosimilar medicinal products and define a procedure for monitoring medicine shortages and reporting to the European Medicines Agency, thus ensuring broader coordination and control at the EU level over the supply stream of medicinal products.

In addition, the new rules plan to introduce a modulated medicine data and market protection system, reducing the standard medicine data protection period from eight to six years. In response to questions raised by MPs and industry representatives, the Ministry of Health explained that the data protection period can be extended for medicines available in all EU Member States with a valid marketing authorisation. Furthermore, medicines delivering on unmet medical needs, addressing an additional therapeutic indication, or studied in comparative clinical trials are also eligible for a protection period extension.

According to the Ministry of Health, the new system could ensure faster access to the data necessary for producing more affordable generics and, in turn, promote competition in the medicines market and reduce prices. Moreover, including cheaper generics in the medicines reimbursement system would help alleviate the health care budget and speed up patients’ access to innovative medicines.

The proposals also plan to introduce higher environmental protection standards in the circulation of medicines. The Ministry described the initiative as the most significant reform of the EU pharmaceutical legislation over the last 20 years.

Referring to the Committee’s inquiries, the Ministry of Health underlined that Latvian citizens currently have access to only 22 percent of the medicines authorised centrally by the EU.

MPs commented that the proposed changes would improve people’s access to medicines, ensuring both broader selection and cheaper prices, and strengthen the overall protection of public health.

At the same time, the Committee emphasised the need for further discussion on improving pharmaceutical legislation to align the diverse interests of stakeholders and ensure better access to medicines for the population.

Saeima Press Service