Potential amendments to the Law on Pharmaceuticals
The Ministry of Healthcare has prepared a draft Law of the Republic of Belarus “On Сirculation of Pharmaceuticals” (in Russian) and published it along with additional information addressing key changes (in Russian) for public discussion (ended on 31 March 2019).
The draft Law is a new version of the Law of the Republic of Belarus “On Pharmaceuticals” currently in force (in Russian).
In general, the draft Law is a step forward in bringing Belarusian national legislation on circulation of pharmaceuticals into compliance with supranational regulations (more than 30 documents) adopted within the Eurasian Economic Union. Main changes would include the possibility to register pharmaceuticals under national procedure and under uniform procedure of the Eurasian Economic Union, which is helpful for applicants in making registration more efficient.
Development of electronic prescriptions regulation
On 30 April 2019 the Ministry of Healthcare website published a draft Resolution (still not yet in force) stipulating, inter alia, instructions as to the procedure for creating, processing, transferring and accepting electronic prescriptions for pharmaceuticals (in Russian). The draft Resolution was prepared following the launch of a pilot project on introduction of electronic prescriptions, which has been successfully implemented in a limited number of healthcare institutions since 2016.
The principle for electronic prescriptions is that doctors issue e-signed prescriptions in electronic form through a special system where healthcare institutions and pharmacies are registered. Patients can obtain prescribed pharmaceuticals upon presentation in pharmacies of special personal cards issued by healthcare institutions where their electronic prescriptions are recorded. The new system is also expected to be more efficient and secure both for doctors and patients.
The draft Resolution (in Russian) stipulates the procedure for connecting healthcare institutions to a centralized system of electronic prescriptions, obligations of doctors related to issuing electronic prescriptions and e-signing, requirements to content of prescriptions, and the validity term of prescriptions (up to 6 months).
Amended procedure for state registration of medical products and equipment
The Council of Ministers has adopted a Resolution (in Russian) dated 2 May 2019 No. 273 (comes into force on 5 August 2019), which introduces changes to the procedure for state (re)registration of medical products and equipment.
According to the document the main changes include:
- new terms “producer of medical products and medical equipment” and “production site”;
- a new ground for state registration — change and (or) addition of a producer and (or) production site of medical products and equipment;
- a rule that previously used and renewed medical products and equipment do not need state registration;
- introduction of specific requirements for modifications of medical products to be included in one registration certificate;
- new grounds for suspension of registration certificates —producer’s resistance to evaluation of the production process ordered by the Ministry of Healthcare and failure by an applicant to provide the Ministry of Healthcare with required information in a set time.
Modernization of public procurement legislation
On 1 July 2019 a new edition of the Law “On Public Procurement of Goods (Works, Services)” (in Russian) comes into force. As far as a large portion of pharmaceuticals and medical products are supplied to Belarus through procurement procedures, respective producers/suppliers should be aware of regulations they should comply with starting from July 2019.
The new edition of the Law introduces, inter alia the following changes:
- obligation to execute contracts only in the form of an electronic document under certain procurement procedures (open tender, electronic auction, procedure for requesting price offers);
- possibility to submit complaints in electronic form in respect of certain procurement procedures;
- shorter period for suspension of the procurement procedure and period for considering complaints (10 working days instead of 30 calendar days);
- introduction of a State Information and Analytical System of Public Procurement Administration. The System is aimed at information support for public procurement and will contain structured data regarding procurement procedures, including tender documents, registers of contracts, complaints, etc.
Other, yet potential, changes to public procurement legislation are set out in the draft Edict of the President of the Republic of Belarus “On issues of Public Procurement of Goods (Works, Services)” (in Russian), which was published for public discussion on 10 June 2019 along with justification of its adoption (in Russian). The key features of the document include:
- a rule that payments under contracts with non-residents must be in Belorussian roubles only, the same as with residents;
- the possibility to conclude contracts as a result of single-source procurement for more than one year;
- the possibility to prolong contracts for products of daily or weekly need (eg, pharmaceuticals) for two months of the following year by means of additional agreement. This measure is supposed to eliminate delays of supplies at the beginning of the year.