Dear clients and cooperation partners,
Belarusian legislation in the healthcare and pharmaceuticals sector is continuing to undergo substantial changes. 2015 was rich with events, with even more expected to come. We offer below, in a few bullet points, our view on factors characterising the state of the Belarusian legislative environment in the pharma and healthcare sector.
- In May 2015 amendments to the Belarusian Law on Pharmaceuticals, adopted in 2014, entered into force. Numerous acts aimed at their implementation were taken up, in particular covering registration procedures, clinical trials, pharmacovigilance, and the retail trade in pharmaceuticals.
- In July 2015 Belarus ratified interstate agreements on a single market of pharmaceuticals and medical devices in the framework of the Eurasian Economic Union. The launch of the single market is expected in early 2016 and may be a game changer in the Belarusian pharma industry.
- Information technologies are continuously being implemented in the framework of the E-Healthcare state programme. Automated statistical systems and digital databases are widely applied in practice; use of electronic prescriptions and on-line consulting is developing.
- A state programme on import substitution is being implemented. The programme aims at enhancing local R&D, boosting local manufacture of pharmaceuticals, and decreasing imports of pharmaceuticals.
Below we provide a brief overview of some recent and expected changes in the Belarusian pharma and healthcare legal environment.
EEU SINGLE MARKET
January 2016 is expected to see the launch of a single market of pharmaceuticals and medical equipment in the framework of the Eurasian Economic Union. Currently the EEU includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia.
By 1 January 2016 over 30 draft acts had been adopted. These establish single rules and principles for movement of pharmaceuticals and medical equipment in the EEU. The drafts cover such issues as state registration, clinical trials, inspection, pharmacovigilance, and information exchange.
The launch of a single market may be a game changer in Belarusian industry. One of the key features of the single market will be the possible validity of a registration certificate issued in one member state in other member state(s) chosen by the applicant.
LICENCING OF MEDICAL ACTIVITY
Recent wide-ranging amendments to the Edict on Licencing also touched upon the pharma industry. The amendments enter into force on 1 March 2016 and concern licencing of medical activity.
In particular, the term of licences will be changed – as of 1 March these will be issued indefinitely. Additionally, the scope of licenced activities will change – services for assembly, commissioning, technical maintenance and repair of medical equipment will be exempt from licencing.
Private healthcare organisations can obtain a licence only if they employ medical specialists with (a) higher and/or specialised secondary education and (b) the first or highest qualification category.
SICK LEAVE CERTIFICATES
Until now the right to issue sick leave certificates vested only with state healthcare institutions. This created practical complications both for patients and for healthcare providers. The long-awaited green light for private healthcare institutions starts from 1 February 2016: these will also be able to issue sick leave certificates.
To do so, institutions will need to comply with the relevant legislative requirements, including having qualified specialists and special premises for storing blank documents.
A medical representative is an important contact point between a healthcare professional and a pharmaceutical company. On 21 May 2015 an Instruction on informing doctors entered into force. This introduced detailed regulation of medical representatives’ activity.
The instruction applies in both state and private healthcare institutions. It sets a number of requirements for representatives (such as a higher medical/pharmaceutical degree), their activity (such as presentation only at events defined by the head of the healthcare institution) and the information they provide (for example, the term “new” may only be used regarding a pharmaceutical registered less than three years ago).
Belarus is continuously implementing GMP standards. On 24 June 2015 two Instructions on inspections of pharmaceutical manufacturing entered into force.
Generally, manufacturing is inspected according to a plan adopted annually by the Belarusian Ministry of Healthcare. Upon successful completion of inspection the Ministry issues a certificate of compliance with the Belarusian GMP. Inspection involves visits to the manufacturing site and examination of the premises. Inspections are also possible in cases of state registration of a pharmaceutical and recognition that a pharmaceutical is of low quality.
A new EEU GMP is expected to be introduced with the launch of an EEU single market of pharmaceuticals and medical equipment.