The European Commission (EC) has expressed reservations about the legal changes proposed by the Bulgarian state, according to which medicines can be exported only if domestic consumption is 100% satisfied. The measure proposed by the Bulgarian authorities aims to put more drugs on the export ban list and limit the quantities that leave the country to be resold at higher prices in other European countries.
The chairman of the parliamentary health committee, Kostadin Angelov, announced on Wednesday that the notification from the EC on the changes to the Law on Medicinal Products in Human Medicine is negative. Later, the EC’s official response was published, stating that “the notified project raises concerns about the free movement of medicinal products within the internal market”.
At the next meeting of the health commission, the changes in the Law on Medicinal Products will be considered together with the EC’s negative notification, Angelov explained.
What do the changes mean?
The changes proposed by the Ministry of Health change the formula used to calculate the shortage of medicinal products in the country and facilitate the ban on their export. Now the export is prohibited when the quantities available in our country fall below 65% of the required to satisfy domestic consumption for a period of one month, calculated on the basis of the average monthly consumption of the relevant medicinal product for the previous 6 months.
With the changes in the ZLPHM, proposes to raise the threshold from 65% to 100% of the necessary quantities to meet health needs of the population for a period of one month, calculated on the basis of the average monthly consumption of the relevant medicinal product. Like the period for which the shortfall will be calculated is changed from 6 to 12 months.
This proposal was reached because now drugs that are not on the prohibited list are also in short supply.
What does the EC say?
In its letter to the Bulgarian authorities, the EC expresses reservations about the proposed text.
“The Commission recognizes the challenges faced by Member States in relation to shortages of medicinal products and is committed to supporting them to ensure adequate supplies. However, The Commission considers that the notified project raises concerns about the free movement of medicinal products within the internal market“the notification said.
The EC recalls that the Treaty on the Functioning of the EU prohibits national restrictions on exports. Export restriction measures may be imposed, only if they are justified, necessary and proportionate to the pursued public objective, in this case guaranteeing the life and health of Bulgarian patients. The EC insists on further clarifications to the notified project, with which the state can prove that the inclusion of medicines in the prohibited export list is imperative. I.e. that the measures are necessary to protect the interests of public health.
The EC also states that according to Directive 2001/83/EC “the holder of a marketing authorization for a medicinal product and the distributors of the medicinal product in question ensure, within the framework of their obligations, the respective regular supplies of this medicinal product to the pharmacies, so that the needs of patients in the concerned Member State are met”.
In addition, before the inclusion of drugs in the prohibited list, the EC calls on the Bulgarian state to contact the European Medicines Agency (EMA) in case of critical shortages, for to use the European mechanisms for its management and mitigation.
During his visit to our country in November last year, the European Commissioner for Health, Stella Kyriakidou, explained that the EC was preparing list of critical drugswhich are in short supply in the European Union and based on it in 2024 will be created a mechanism for voluntary solidarity sharing and exchange of medicines between Member States.
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