Brussels warns RS: Collapse will occur if you establish an Agency for Medicines!

(Patria) - Suspend all activities on establishing the Agency for Medicines and Medical Devices at the level of Republika Srpska, this will lead to market disruptions and affect patients and healthcare, said the Director for Neighbourhood and Enlargement Negotiations at the European Commission, Maciej Popowski, in a letter to the highest officials of Republika Srpska, which is in the possession of the portal CAPITAL.

The letter was sent a few days ago to the President of Republika Srpska, Željka Cvijanović, the Speaker of the National Assembly of RS, Nedeljko Čubrilović, the Prime Minister of RS, Radovan Višković, and the Chairman of the Council of Ministers of BiH, Zoran Tegeltija.

In the letter, Popowski expressed serious concern over the adoption of the Law on Medicines and Medical Devices by the National Assembly of RS, which he states derogates the existing Law on Medicines and Medical Devices at the BiH level, adopted in 2008.

“The establishment of the Agency for Medicines and Medical Devices of Republika Srpska would create legal uncertainty in the market of medicines and medical devices with inevitable harmful effects on citizens and the economy, while undermining the single economic space in the country,” Popowski stated.

He claims that the constitutional framework of BiH does not provide a legal basis for the unilateral withdrawal of entities from established BiH institutions, nor for prohibiting the application of BiH legislation in entities, emphasizing that entities and their units must fully comply with the decisions of BiH institutions.

“For pharmaceutical manufacturers, the RS law would mean that they must obtain two different marketing authorizations for medicines, which are not mutually recognized. This can cause a collapse of the medicine supply chain from abroad. To trade in RS and throughout BiH, companies will have to be under the control of laboratories and the RS Agency and the Agency at the BiH level, which may apply different regulations,” Popowski points out.

He added that the expiry of marketing authorization for a medicine could lead to medium-term and long-term shortages of medicines and medical devices in Srpska, and potentially in the entire BiH.

“Citizens’ right to equal access to healthcare and medicines throughout BiH would be seriously violated. Health institutions, already exhausted in the fight against the COVID-19 pandemic, may not be able to provide quality healthcare services to patients. In addition, there is a high risk of unequal patient protection in terms of the efficacy, quality, and safety of medicines and medical devices in RS and throughout BiH,” Popowski adds.

All of this, he emphasizes, could be even worse for patients who rely on innovative, biological, or similar medicines, due to the lack of alternatives.

He reminds that the European Commission’s Opinion on BiH’s EU membership application established that BiH, among other things, needs to simplify and harmonize business registration and licensing procedures between entities in order to improve the business environment and create a single economic space.

“The EU recommendations from the meetings of joint bodies within the framework of the Stabilization and Association Agreement (SAA) between the EU and BiH are aimed at ensuring quality and accessible public healthcare for all citizens. If the RS Law on Medicines is implemented, BiH would regress in harmonization with EU legislation, and this would further delay BiH’s path to EU membership,” Popowski states.

In the interest of all citizens and businessmen in BiH, he calls on the officials of Srpska to stop establishing the Agency for Medicines and Medical Devices at the RS level.

“I appeal to you to suspend all activities that lead to the entry into force and application of the RS Law on Medicines and Medical Devices and the establishment of the RS Agency for Medicines and Medical Devices. Similar attempts to undermine BiH’s legislation and institutions, especially in contradiction with BiH’s obligations under the SAA, will also negatively affect the country’s integration process into the EU,” Popowski concludes in the letter to the RS officials.

We remind that the National Assembly of RS adopted the Law on Medicines and Medical Devices of Republika Srpska on October 20, which defines the formation of an entity Agency for Medicines. The law enters into force six months after its publication in the Official Gazette of RS.

The Minister of Health of RS, Alen Šeranić, explained that the adopted law is practically a copied law that is currently in force in BiH, except that it transfers jurisdiction to the new RS Agency for Medicines.