Dear clients and cooperation partners,
Belarusian healthcare legislation is currently undergoing substantial changes. The reform primarily concerns circulation of pharmaceuticals but also touches upon other issues in the field of medicine and healthcare. The ongoing changes may be interesting for both patients and the business community.
Below we offer a review of some changes to key legal acts.
LAW ON PHARMACEUTICALS
Amendments implemented on 17 November 2014 enter into force on 21 May 2015.
- In the course of registration the applicant must indicate the maximum sale price of a pharmaceutical. The declared price should be comparable to the sales price in the country of manufacture, in member countries of the Eurasian Economic Union and other countries neighboring Belarus (if the pharmaceutical is registered there). The declared price is included in a registration certificate. Exceeding the declared price in a supply contract could lead to suspension of the registration certificate.
- The possibility to obtain an indefinite registration certificate is envisaged: for a pharmaceutical registered for the first time a registration certificate is issued for five years. Upon expiration of this term the applicant may undergo confirmation of registration and obtain an indefinite certificate.
- Pharmaceuticals intended only for industrial manufacture for export no longer require state registration.
- The notion of a system of pharmacovigilance is introduced. This is defined as a set of activities that involve detecting changes in the benefit-risk ratio of pharmaceuticals and minimizing adverse consequences from their usage. Manufacturers of pharmaceuticals will have to ensure organization and functioning of a pharmacovigilance system according to the requirements of Good Pharmacovigilance Practice adopted by the Ministry of Healthcare.
- The list of cases allowing out-of-pharmacies retail trade of pharmaceuticals is extended: sale of pharmaceuticals in international thematic exhibitions plus international sports and cultural events will be permissible.
- New terms are introduced, such as “international nonproprietary name of a pharmaceutical”, “biological pharmaceutical”, “orphan pharmaceutical”.
LAW ON HEALTHCARE
Amendments implemented on 16 June 2014 enter into force on 27 December 2014.
- The list of persons who may be provided with data constituting a medical secret without the patient’s consent is extended. These persons include, in particular, insurance companies, local military authorities (in the case of call-up to military service) and employers (in the case of an accident investigation from manufacturing or an occupational disease).
- The notions of Official list of medical devices and Official list of pharmaceuticals are introduced – these are lists of medical devices and pharmaceuticals which comply with safety, effectiveness, and quality requirements and which are most economically expedient for the purpose of using state funds allocated for healthcare. Drafting and annual renewal of the lists is the task of the Ministry of Healthcare.
- The right of a doctor to abstain from performing an abortion is introduced: this right may be exercised when abstention does not endanger the life and (or) health of a woman. The head of the healthcare institution must arrange an abortion by another doctor.
- Ministry of Healthcare Regulation No. 66, which entered into force on 19 October 2014, changed the framework of the pharmaceuticals retail trade. In the case of full-price sale of pharmaceuticals, doctor’s prescriptions are taken from the patient and stored in the pharmacy during established terms of storage. Additionally, doctors must issue prescriptions taking into account not only the patient’s diagnosis, age, and so on, but also the price affordability of the pharmaceutical.
- On 27 August 2014 the Belarus Council of Ministers adopted a Regulation on the Ministry of Healthcare joining the Pharmaceutical Inspection Co-operation Scheme – Association de Droit Suisse.
- On 27 December 2014 Belarus Council of Ministers Regulation No. 1120 enters into force, establishing a procedure for registration of biomedical cell products. Biomedical cell products are defined as transplantation material based on human cells (except for embryonic, genetically modified and certain other human cells).
- Currently expected: adoption of a range of legal acts aimed at realizing the changes and ensuring compliance of existing legislation with updates of legal acts.