Belarus — Health and Pharma Overview

Health and Pharma Industry Regulation in Belarus – overview for Data Guidaince. Authors – Tatiana Ignatovskaya and Nadezhda Hadanovich.

INTRODUCTION
CLINICAL RESEARCH/TRIALS
PHARMACOVIGILANCE & MARKETING OF PRODUCTS
BIOBANKING
DATA TRANSFERS
BREACH NOTIFICATION
OTHER AREAS OF INTEREST
CONCLUSION

1. INTRODUCTION

1.1. Key acts, regulations, directives, guidelines, decisions and case law

In Belarus there is no separate law or regulation covering solely data protection. Belarus is not a member of the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data 1981, as elaborated and adopted within the Council of Europe. Currently only the concept of the Law On Personal Data exists, and will be submitted for adoption by the President of Belarus in September 2017. The concept of the Law On Personal Data is currently unavailable to the public. As a consequence, there is no any separate and/or special supervisory authority in this field responsible for enforcement of personal data regulation. Currently there is even no responsibility established for violation of this regulation. However, it is expected that administrative liability will be established for personal data disclosure; the draft law providing for this amendment (‘the Draft Law on Penalties’) has been introduced to the Parliament of Belarus and was adopted by the House of Representatives in the first reading in mid-December 2016.

Nevertheless, partial regulation exists. General regulation is provided in the Law of the Republic of Belarus of 10 November 2011 No. 455-Z on Information, Informatisation and Data Protection’ (‘Law on Information’), only available in Russian here. Some terms and definitions relation to personal data are also defined in the Law of the Republic of Belarus of 21 July 2008 No. 418-Z on the Population Registry, only available in Russian here. This regulation is very general and is similar for any industry sectors, including medicine and healthcare. The main principle is data processing conducted on the basis of the personal data subject’s written consent.

Belarusian laws do not recognise the division of personal data into sensitive and non-sensitive categories and therefore, there are no separate rules for turnover of sensitive data, to which medical data do in general relate. However, the definition of personal data is rather broad; it is defined as main and supplementary personal data of the natural person subject to inclusion into the population registry due to the legislative acts of the Republic of Belarus as well as other data that allows identifying that person. Therefore, there is also no division into direct and indirect personal data provided for by the law.

At the same time, separate regulation exists in relation to medical data as such, which are considered to be one of the types of legally protected secrets. According to the Law of the Republic of Belarus of the Republic of Belarus of 18 June 1993 No. 2435-XII on Healthcare (‘Law on Healthcare’), only available in Russian here, information about the fact of the patient’s utilisation of medical resources and the state of his (her) health, information about the presence of a disease; a diagnosis; possible methods of medical aid provision; the risks connected with medical interference as well as possible alternatives to medical interference; and other data, including those of personal character, received within the provision of medical aid to a patient, and in case of death, information about the results of patho-anatomical research, are considered as comprising medical secrets.

Separate information is also defined as medical secrets by the Law of the Republic of Belarus of 7 January 2012 No. 341-Z on Auxiliary Reproductive Technologies, regulating information on application of auxiliary reproductive technologies as well as about the personality of the patient, donor; and by the Law of the Republic of Belarus of 7 January 2012 No. 349-Z on Psychiatric Aid Provision, only available in Russian here, regulating information about the fact of patient’s psychiatric recourse utilisation and state of his (her) mental health, information about the presence of a mental disorder (disease), diagnosis, other data, including those of personal character, received within psychiatric aid provision to a patient.

Such information may be also provided (disclosed) only on a basis of the consent of the patient, or their legal representatives in cases of minors or other legally incapable persons. Criminal as well as administrative liability is established in cases of illegal disclosure of medical secrets.

2. CLINICAL RESEARCH/TRIALS

2.1. Regulations governing clinical research and trials

2.1.1. Clinical trials of drug products

General regulation of drug products’ clinical trials conducting is provided in by the Law of the Republic of Belarus of 20 July 2006 No. 161-З on Drug Products. Preclinical research conducting is also possible, however, it may not involve research on natural persons.

More detailed national regulation is provided in by the technical code of established practice ‘Good Clinical Practice’ adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 7 May 2009 No. 50 on Some Issues of Drug Products’ Clinical Trials Conducting, only available in Russian here, and the Instruction on the order and conditions of inspecting of drug products’ clinical trials on the issue of their correspondence to the Requirements of Good Clinical Practice adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 17 April 2015 No. 46.

Apart from at a national level, supranational regulation exists at the level of intergovernmental institution the Eurasian Economic Union, a party to which is the Republic of Belarus. In particular, the Decision of the Council of the Eurasian Economic Commission No. 79 on the Adoption of the Rules of Good Clinical Practice of the Eurasian Economic Union, only available in Russian here, that entered into force this year, and lays down unified common provisions for drug products’ clinical trials conducting for all member-states, and, is not subject to present analysis due to its supranational character.

2.1.2. Clinical trials of products of medical purpose and medical equipment

Separate rules are applicable in relation to clinical trials of products of medical purpose and medical equipment (‘medical devices’). This regulation is provided in by the Instruction on Clinical Trials of Products of Medical Purpose and Medical Equipment Conducting, as adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 18 December 2008 No. 216 on Some Issues of Clinical Trials of Products of Medical Purpose and Medical Equipment Conducting.

Similarly, as in relation to drug products unified regulation at the level of the Eurasian economic union exists, notably the Decision of the Council of the Eurasian Economic Commission No. 29 on Rules of Medical Devices’ Clinical and Clinical and Laboratory Trials (Research) Conducting, that entered into force this year, although this is not presently subject to analysis due to its supranational character.

2.2. The nature of data collected and processed

2.2.1. Clinical trials of drug products

Participation of patients in drug products’ clinical trials is voluntary. These types of clinical trials are conducted only in case of presence of written consent of the patient on participation in particular drug product clinical trials conducting. In case of minors participation in clinical trials such trials are conducted in case of presence of written consent of one of the parents. In case of the participation of persons that are unable to make a conscious decision upon their state of health, the presence of written consent of the spouse or one of the close relatives, ie. parents, children of majority age, siblings, grandchildren, grandparents, is obligatory.

There are categories of natural persons established that may not participate in drug product’s clinical trials.

Patients are entitled to refuse from participation in drug products’ clinical trials at any stage of their conducting, and, therefore, to recall their consent on participation. This consent should be made in the form of an informed written consent (‘IWC\) of the participant or their empowered representative, in the cases described above.

IWC provides for a wide range of information to be presented to the patient, among which is a guarantee that the personal identifying documentation will be kept confidential and will be unavailable to the public within the framework established by the legislation of the Republic of Belarus. Within publication of the clinical trials results anonymity of the participant should be preserved.

However, the issues involved in the processing of personal identifying information are not provided in by the special regulations described and are governed by the Law on Information, which does not provide for the ability of the personal data subject to, for instance, recall its consent for personal data processing or demand their deletion. Thus, even in the case if the participant has used his (her) ability to refuse from further participation in clinical trials conducting, their personal data may be still processed by the organisation conducting such trials.

Since there is no distinction between sensitive personal data and non-sensitive personal data, such information may be processed and further transferred on the basis of the simple consent of the participant as a personal data subject, or just processed inside the organisation or institution conducting clinical trials.

2.2.2. Clinical trials of medical devices

The order of participant’s consent receipt for participation in the medical devices’ clinical trials is similar to the order described above in relation to drug products’ clinical trials. IWC should be received from the participant, which is defined as a document, in which the participant or their legal representative approves his voluntary consent on participation in particular clinical trial after acquaintance with all its peculiarities that may influence on the decision of the participant.
Nevertheless, the rules of processing of personal identifying information are similar, i.e. they are almost absent except for simple consent provision.

3. PHARMACOVIGILANCE & MARKETING OF PRODUCTS

3.1. Information relating to the reporting in a pharmacovigilance context

3.1.1. Drug products

Legislation on the issue of pharmacovigilance was lately (in 2015) updated in the Republic of Belarus. In 2017 supranational legislation has also entered into force; specifically, the Rules on Good Pharmacovigilance Practice of the Eurasian Economic Union adopted by the Decision of the Council of the Eurasian Economic Commission No. 87, only available in Russian here. These rules provide for unified result for all the involved markets (Belarus, Armenia, Kazakhstan, Russia, Kyrgyzstan and, thus, not being subject to the present analysis due to its supranational character.

The issues of pharmacovigilance conducting are governed by the following legal acts in Belarus:

– The technical code of established practicr entitled the Good Pharmacovigilance Practice, as adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 4 June 2015 No. 80 on the Adoption of the Technical Code of Established Practice;

– The Instruction on the Order of Organisation of the System of Pharmacovigilance and the Order of Control of Manufacturers of Drug Products on the Issue of the Correspondence of Organisation and Functioning of the Pharmacovigilance System to the Requirements of Good Pharmacovigilance Practice, as adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 20 May 2015 No. 75.

Good pharmacovigilance practice establishes several requirements for the procedure for management of the received data within the reports on adverse reactions that usually contain personal information about the patient and the healthcare professionals that have prepared the report.

Electronic data and paper reports on suspected adverse reactions should be stored and processed as other medical notes, including requirements on confidentiality insurance in relation to patients’ and reporters’ identification and in accordance with the requirements of the national legislation on inviolability of data. Identifiable personal information about the healthcare professionals that have prepared the reports should be kept confidential.

In order to ensure safety and confidentiality of the pharmacovigilance data strict access control to the documents and databases should be applied, i.e. the access may be provided to the duly empowered personnel only. This requirement on data safety provision is spreading on all the stages of data processing. Therefore, the procedures of data safety provision within its transfer should be realised.

If pharmacovigilance data transfer is conducted within one organisation or between organisations, such mechanism should be applied within application of which there is a confirmation that all the notices were received; in that case, it is obligatory to provide the process of confirmation and/or reconciliation.

Information upon report about the case of adverse reaction development may be transferred only between the interested persons in anonymous format. Within the conducting of drug products’ clinical trials, in cases when adverse reactions are revealed, it is also necessary to provide the report on respective adverse reaction on the drug product. However, there are no special rules applicable to such reports, besides of the general mentioning that these reports should correspond to the requirements of the Belarusian laws.

Nevertheless, besides general regulation provided in the Good pharmacovigilance practice the order of provision of the information about the adverse reactions revealed is established by special Instruction on the Order of the Provision of the Information about Revealed Adverse Reactions on Drug Products, as adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 17 April 2015 No. 48, only available in Russian here. However, this document does not contain any special provisions in addition to the Good Pharmacovigilance Practice in relation to the applicable order and rules of data processing.

3.1.2. Medical devices

Since there is no special national law in relation to the order of medical devices turnover, the regulation exists at a level of regulations and (or) even letters of the Ministry of healthcare of the Republic of Belarus. In particular, the issues of quality control in relation to medical devices are regulated by the Letter of the Ministry of Healthcare of the Republic of Belarus of 10 July 2013 No. 11-15/827-528 on the Usage in Work, only available in Russian here. This letter establishes the template of a notice on adverse reactions revealed, disadvantages, malfunctions or inconsistencies of the medical devices used to the established requirements, as well as the requirements for its filing.

However, the only requirement established in relation to the data presented in the Notice is its correspondence to practice in reality. There are no indications that the data provided should be kept confidential or that their transfer is somehow restricted.

3.2. Advertising and marketing of products

Advertising and marketing of medical products is conducted in accordance with the requirements envisaged by the Law of the Republic of Belarus of 10 May 2007 No. 225-Z on Advertisement (Article. 15) (‘the Law on Advertisement’), only available in Russian here, and the Resolution of the Ministry of Healthcare of the Republic of Belarus of 23 July 2013 No. 63 on Some Measures on the Realisation of Articles 15 and 15-1 of the Law of the Republic of Belarus of 10 May 2007 on Advertisement and Recognition of some Resolutions of the Ministry of Healthcare of the Republic of Belarus as Invalid.

Separate rules are established in relation to advertisement of prescriptive and non-prescriptive drug products, the latter may be distributed only in case of presence of the Ministry of healthcare approval. Advertisement of prescriptive drug products has special type of advertisement consumers – medical and pharmaceutical employees (‘HCP’).

Advertisement of non-registered drug products and medical devices is, in general, prohibited. Such advertisement should contain indication that the information distributed is of advertisement character.

The advertisement should obligatorily contain:

– the name of the drug product or medical device;

– an indication that the advertisement object is a drug product or a medical device;

– the name of the manufacturer of the drug product or medical device;

– a recommendation on the necessity to get acquainted with the instruction on medical usage or consultation with a doctor (not applicable for advertisement of drug products/medical devices intended for HCPs).

The advertisement should not contain:

– information addressed to minors;

– statements about medical effect of the drug product in relation to diseases that are not cured or hardly cured;

– statements that the medical effect in case of usage of the advertisement object is absolutely guaranteed, etc.

However, the Law on Advertisement does not contain any special provisions in relation to the necessity to attain the consent of the advertisement consumer in cases of direct promotion. Nevertheless, general regulation envisaged by the Law on Information will be applicable in cases when personal data of HCPs are processed, for instance, by the medical representatives of pharmaceutical companies.

Nevertheless, for some types of advertisement distribution, the receipt of the advertisement consumer’s consent is obligatory. In particular, the distribution of advertisement via telephone, telex, facsimile, mobile network, e-mails are allowed only in case of presence of consent of the subscriber or recipient for advertisement receipt. The distributor of advertisement is obliged to cease distribution of advertisement upon receipt of first request to do so from the subscriber (recipient). However, this means of advertisement distribution (within the electric network) is not usually applicable in relation to the advertisement of drug products or medical devices.

In addition to advertisement of drug products and medical devices regulation as such also the order of information distribution by the representatives of drug products’ manufacturers among HCPs is regulated. This order is established by the Instruction on the Order and Conditions of Informing of Medical and Pharmaceutical Employees about the Drug Products Included into the State Registry of Drug Products of the Republic of Belarus by the Representatives of Drug Products’ Manufacturers adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 17 April 2015 No. 44, only available in Russian here.

Due to the presence of separate regulation in relation to such requirements to inform, such distribution may be not regarded as advertisement distribution, however, special conditions must be met in order to acknowledge information distribution as informing instead of advertising. In particular, it may be conducted only by the representatives of the drug product’s manufacturer and in relation to those drug products that are included into the Registry. Moreover, the requirements to inform may be conducted only in one of the following forms:

– An oral presentation with or without the demonstration of informational and other materials about the drug product, including on electronic media, within meetings, conferences, seminars, symposiums and other events designated by the head of the healthcare organisation;

– The distribution of information materials in places designated by the head of the healthcare organisation.

Special requirements to the information presented are established, including the capacity of the information to be provided.

It is worth mentioning that by this instruction, it is directly prohibited for the representatives of drug products’ manufacturers to enter the offices or other staff sites of the healthcare organisation or distract the employees of the healthcare organisation from their official duties conducting.

4. BIOBANKING

There are no separate and (or) special regulation in respect of biobanking in Belarus.

Nevertheless, several registers containing medical information exist. In particular, the mentioned Law of the Republic of Belarus of 7 January 2012 No. 341-Z on Auxiliary

Reproductive Technologies provides for creation of unified register of sex cell donors. Donation of sex cells is carried out on the basis of a written application of the donor either on a paid or on a gratuitous basis. Donor in relation to the patient may be either anonymous or non-anonymous. Only a relative of a patient may be a non-anonymous donor; in relation to a female patient – her relative of a female sex, in relation to a male patient – his relative of a male sex.

Donor sex cells may be used either for purposes of medical aid provision to the patient or for scientific and research purposes (in relation to those donor sex cells that were unclaimed). Information about anonymous donors, the number of fertilisation attempts using the sex cells of one anonymous donor are provided for inclusion into the unified register of sex cell donors in coded form by the healthcare organisations to the Ministry of Healthcare of the Republic of Belarus.

The order of its conducting is established by the Regulation of the Order of Creation and Conducting of the Unified Register of Sex Cell Donors, as adopted by the Resolution of the Council of Ministers of the Republic of Belarus of 13 July 2012 No. 643. It is directly stated that the data subject to inclusion into the unified register compose medical secrets.

The Law of the Republic of Belarus of 30 November 2010 No. 197-Z on the Donation of Blood and its Components provided for creation of Unified database of donation of blood, its components. This database contains, in particular, the information that allows to identify the personality of the donor and the personality of the recipient. The order of this database creation and conducting is established by the Instruction on the Order of Creation and Conducting of the Unified Database of Donation of Blood and its Components, Usage and Provision of Information Contained in it, as adopted by the Resolution of the Ministry of Healthcare of the Republic of Belarus of 22 May 2015 No. 77, only available to download in Russian here.

The database is conducted by astate institution, entitled the Republican Scientific and Practical Centre of Transfusiology and Medical Biotechnologies. Information included into the database and composing medical secrets are provided in accordance with Article. 46 of the Law on Healthcare. Moreover, it is directly stated that information included into the database and relating to the information about personal life of a natural person and their personal data are provided in accordance with Article 18 of the Law on Information, i.e. on the basis of a written consent of a personal data subject. In addition, information contained in the database should be protected in accordance with the mentioned Law on Information.

5. DATA TRANSFERS

5.1. Specific restrictions and exemptions relating to the transfer of sensitive personal data

The Belarusian Law on information does not impose any specific rules in connection with personal data transfer, including the cross-border data transfer, except for general rule of written consent of personal data subject receipt in order to provide for their subsequent transfer. Therefore, there are no special restrictions established.

Moreover, since there is no division of personal data onto those relating to sensitive and non-sensitive ones, there are no special restrictions and (or) exemptions to the transfer of sensitive personal data that may be underlined.

6. BREACH NOTIFICATION

There are no provisions provided in by the Belarusian legislation concerning the issue of data breach notification. Probably, these special provisions may be envisaged in the Draft Law on Personal Data, subject to adoption in future.

As it was indicated there is no responsibility established for violation of personal data regulation due to absence of adequate regulation. Nevertheless, some types of personal data may be regarded as personal or family secret, the disclosure of which may result in criminal liability of the offender. Moreover, some types of data may be also regarded as legally protected secrets (for instance, as medical secrets).

7. OTHER AREAS OF INTEREST

7.1. Obligation of usage of networks, systems and resources of national Internet segment

It should be noted that usage of national Internet segment is in general regulated in the Republic of Belarus since 2010. In particular, it is obligatory for the legal entities and individual entrepreneurs registered in Belarus to conduct commercial actives (sales of goods, provision of services, performance of works) within the internet with the usage of information networks, systems and resources of national Internet segment, placed in the territory of Belarus and registered in accordance with an established order. In the national internet segment, a complex of information networks, systems and resources having an Internet connection and placed in the territory of Belarus and (or) using hierarchical names of the national internet segment will be considered as within this scope.

This regulation provides for the necessity of, in particular, Belarusian online-stores to conduct their activities with the usage of servers located in Belarus and services of local hosting providers. It also imposes the necessity for Belarusian companies conducting Internet activities to collect personal data of clients within such activities with the usage of information networks, systems and resources of national Internet segment.

For instance, the necessity to comply with the mentioned requirements arises in cases if a Belarusian company provides a service that allows patients to register for the receipt of medical aid online.

7.2. Requirements to data protection system of information systems in which personal data are processed

Notwithstanding rather vague regulation existing in connection with personal data processing in general, rather strict rules are applicable in cases when technical or cryptographic means of information protection are applied to the information systems, in which personal data are processed. Activities in the field of technical and cryptographic information protection are one of the licensed activities types, for example, see the unified requirements for licensing as provided by the Edict of the President of the Republic of Belarus of 1 September 2010 No. 450 in Separate Activities Types Licensing, on available in Russian here. However, obtaining a special permit (license) is obligatory only in cases if works on technical and (or) cryptographic information protection are conducted not by the owner of the information of which distribution and (or) provision of which is restricted, including personal data.

Regardless the absence of necessity to obtain a special permit (license) for owners of information systems in which personal data is processed, within the application of technical or cryptographic means of information protection to such systems, it is obligatory to comply with the requirements of special Regulation on technical and cryptographic information protection in the Republic of Belarus adopted by the Edict of the President of the Republic of Belarus of 16 April 2013 No. 196 on Some Measures on Improvement of Information Protection, only available in Russian here.

In case of the application of technical measures, it is obligatory for the system’s owner to provide information about the state of the technical information protection to the Operative and analytical center under the aegis of the President of the Republic of Belarus (‘OAC’). The procedure for the attestation of informatisation objects and information protection systems should be fulfilled by the system’s owner. Within the application of technical information protection measures, means of technical information protection will be issued a certificate of conformity by the the National system of conformity assessment of the Republic of Belarus or by a positive expert conclusion upon the results of state expertise conducted by OAC.

The decision to organise cryptographic information protection is taken by the owner of the informational system that designated for processing of information, the distribution and (or) provision of which is restricted, within the realisation of a complex of activities on the creation of information protection system. The means of cryptographic information protection are subject to certification in the national system of conformity assessment of the Republic of Belarus on the basis of their correspondence to the requirements of technical normative legal acts or state expertise.

It should be underlined that the described rules of technical or cryptographic means of information protection usage will be applicable in cases when the information system is located in the territory of Belarus.

7.3. Penalties

Under the Draft Law on Penalties, the fines that are planned to be introduced are rather low: from approximately $50 up to approximately $240.

8. CONCLUSION

The existing regulation in the field of personal data protection is rather vague. In particular, there are no special rules applicable in cases of cross-border personal data transfer, personal data are not subdivided into sensitive and non-sensitive. Nevertheless, special rules are applied in relation to medical secrets as legally protected types of information.

It is expected that the regulation in the field of personal data protection and processing will be adopted in the nearest future; in particular, the Draft Law on Personal Data is expected to be adopted in 2018. Nowadays, the regulation of data protection may be characterised as fragmentary and, therefore, not always easy to apply by the interested subjects.