Health Ministry trying to regulate pharmaceutical market again – activists

The Health Ministry of Ukraine wants to cancel the simplified registration of pharmaceuticals, introduced by the Cabinet a few days ago.

This is reported by the activists of organizations of patients.

The changes, introduced by the Ministry in the bill No. 4484, nullify the most advanced standards of this document.

“The bill as amended by the Health Ministry does not deregulate, but, vice versa, heavily regulates the pharmaceutical market. It actually creates the possibility for manual mode of access of the medicines to the market. The worst thing is that under the guise of simplified procedure, i.e. deregulation, the Health Ministry complicates the simplified registration procedure, which already exists for certain categories of serious diseases: HIV/AIDS, tuberculosis, cancer, hepatitis, orphan diseases. It cannot be allowed,” said Lana Sinichkina, the partner at Arzinger law office.

In particular, the Ukrainian Health Ministry proposes to limit the list of medicines under accelerated procedure to only those that do not have analogues in Ukraine. In addition, the Ministry wants to introduce a manual mode of access of the medicines from the developed countries such as the EU or the United States to the Ukrainian market. This means that the applicant should prove the compliance of a medicine with a number of fuzzy and confusing requirements for a simplified procedure to be launched.

“Now, the seriously ill patients, their families and volunteers actually become smugglers, because they have to illegally import necessary medicines, which are not registered in Ukraine, in order to save lives. The bill, initiated by Volodymyr Groysman, was truly progressive and became the hope for all these people to get an opportunity to buy necessary medicines in Ukraine. However, the Health Ministry finalized the bill and completely changed its meaning. Now the Ministry heavily regulates the pharmaceutical market instead of deregulating it. Now it will be impossible to break the monopoly and expand access of Ukrainian patients to quality medicines. We’ll have a setback instead of the reform initiated by the government,” said Olha Stefanyshyna, the Executive director of the Charitable Foundation “Patients of Ukraine.”

According to statistics provided by the activists, 80% of residents of Ukrainian towns and 82% of Ukrainian villagers cannot buy medicines because of their high cost. 1,600 patients die from a lack of medicines in Ukraine every day.