Rules have been established for companies to communicate with health care and pharmaceuticals professionals as have rules for holding events financed by companies. Liability has been introduced for a number of violations in the sphere of public health
Pepeliaev Group advises that on 25 November 2013 the President signed Law No. 317-FZ “On amending certain pieces of legislation of the Russian Federation and repealing certain provisions of Russian legislative acts regarding the protection of public health in the Russian Federation” (the “Law”).
Amendments have been made to 57 federal laws, the reason for these being that provisions of legislative acts need to be brought into line with Federal Law No. 323-FZ dated 21 November 2011 “On the fundamental basic principles of protecting public health in the Russian Federation” (the “Law protecting public health”).
The amendments are extensive; however businesses should pay attention primarily to the following new legislative developments.
Brief contents of certain amendments
1. Limitations have been set for companies with regard to communicating with medical (pharmaceutical) professionals, similar to those set out for individuals in Federal Law No. 61-FZ dated 12 April 2010 “On the circulation of medicines” (the “Law on the circulation of medicines”).
Limitations were imposed on developers, manufacturers of medicines for medical use, companies that have the rights to use a trade name of a medicine for medical use, distributors and pharmacies.
Companies are forbidden to:
• make presents, pay money to the above professionals, among other things, to pay for entertainment, vacations or trips to the place of vacations;
• engage these professionals in entertainment events organised at the companies’ expense;
• sign with medical (pharmaceutical) professionals agreements to prescribe or recommend medicines to patients for medical use;
• present samples of medicines for medical use to hand them over to patients.
The above restrictions do not apply to clinical studies of medicines, or pedagogical and/or academic activity carried out by a medical professional.
Moreover, companies may not do the following:
• provide inaccurate and/or incomplete information regarding medicines to medical professionals or information about medicines that have the same international generic name to pharmaceutical professionals.
• visit medical professionals during their working hours at their work places (i.e. the law defines the concept of an “appointment”), except for situations connected with clinical studies of medicines for medical use in which the companies are participating, according to the procedure established by the head of the medical organisation, in meetings of medical professionals and other events aimed at enhancing their professional level or providing information connected with monitoring the safety of medicines;
• encourage medical professionals to prescribe medicines on forms containing advertising information, as well as on prescription forms where the name of the medicine has been already typed.
2. Requirements have been set out for organising and holding academic events financed by companies, aimed at enhancing the professional level of medical professionals or at providing information connected with monitoring the safety of medicines.
From now on the companies that organise (finance) events, as well as the representatives of such companies, are forbidden to prevent from participating in such events their competitors which manufacture and sell medicines with a similar pharmacological effect and to establish discriminatory terms and conditions for some participants as compared to other participants, namely:
1) allocate different amounts of time for participants’ reports, provide areas of different sizes for demonstrating samples of medicines or advertising materials about medicines at expositions or stands;
2) establish for participants of the events a fee that exceeds expenses on organising these events, which results in an unjustified restriction in the number of participants.
Companies that organise (finance) events and the representatives of such companies must post information about the event on their official websites, including information about their plans, event programmes, topics that will be discussed and the list of participants, not later than two months before the start of the event. They also must submit this information to the Federal Service on Surveillance in Healthcare (Roszdravnadzor) for this information to be posted on this state authority’s official website. No requirements for notifications have been developed yet.
3. New elements of public health-related administrative offences have been added to the Russian Administrative Offence Code:
The new elements of offences may for convenience be divided into four groups:
• elements of offences that establish liability for violating the rules for trading in medical products, retailing (wholesaling) medicines or selling poor quality or counterfeit medication (fines of RUB 20,000-100,000);
• elements of offences that establish liability for medical professionals and heads of medical organisations in relation to regulations covering a conflict of interests (fines of RUB 3,000-10,000)
• elements of offences that establish liability for medical organisations in the area of implementing the state guarantee programme for free medical assistance to individuals (fines of RUB 10,000-30,000);
• elements of offences that establish liability for failing to comply with Rozdravnadzor’s requirements or preventing this state agency or its officials from exercising their powers (fines of RUB 20,000-70,000).
Therefore, it is presumed that Roszdravnadzor will now obtain a sufficient set of tools to encourage companies to comply with its requirements and to normalise the situation on the market of pharmaceutical and medical products.
On 25 November 2013, the Law was published on the official internet portal for legal information (www.pravo.gov.ru); it came into force from the date when it was published, except for the amendment specified in clause 3 of this alert; these will come into force on 1 January 2014.
Limitations were imposed on developers, manufacturers of medicines for medical use, companies that have the rights to use a trade name of a medicine for medical use, distributors and pharmacies.
Companies are forbidden to:
• make presents, pay money to the above professionals, among other things, to pay for entertainment, vacations or trips to the place of vacations;
• engage these professionals in entertainment events organised at the companies’ expense;
• sign with medical (pharmaceutical) professionals agreements to prescribe or recommend medicines to patients for medical use;
• present samples of medicines for medical use to hand them over to patients.
The above restrictions do not apply to clinical studies of medicines, or pedagogical and/or academic activity carried out by a medical professional.
Moreover, companies may not do the following:
• provide inaccurate and/or incomplete information regarding medicines to medical professionals or information about medicines that have the same international generic name to pharmaceutical professionals.
• visit medical professionals during their working hours at their work places (i.e. the law defines the concept of an “appointment”), except for situations connected with clinical studies of medicines for medical use in which the companies are participating, according to the procedure established by the head of the medical organisation, in meetings of medical professionals and other events aimed at enhancing their professional level or providing information connected with monitoring the safety of medicines;
• encourage medical professionals to prescribe medicines on forms containing advertising information, as well as on prescription forms where the name of the medicine has been already typed.
2. Requirements have been set out for organising and holding academic events financed by companies, aimed at enhancing the professional level of medical professionals or at providing information connected with monitoring the safety of medicines.
From now on the companies that organise (finance) events, as well as the representatives of such companies, are forbidden to prevent from participating in such events their competitors which manufacture and sell medicines with a similar pharmacological effect and to establish discriminatory terms and conditions for some participants as compared to other participants, namely:
1) allocate different amounts of time for participants’ reports, provide areas of different sizes for demonstrating samples of medicines or advertising materials about medicines at expositions or stands;
2) establish for participants of the events a fee that exceeds expenses on organising these events, which results in an unjustified restriction in the number of participants.
Companies that organise (finance) events and the representatives of such companies must post information about the event on their official websites, including information about their plans, event programmes, topics that will be discussed and the list of participants, not later than two months before the start of the event. They also must submit this information to the Federal Service on Surveillance in Healthcare (Roszdravnadzor) for this information to be posted on this state authority’s official website. No requirements for notifications have been developed yet.
3. New elements of public health-related administrative offences have been added to the Russian Administrative Offence Code:
The new elements of offences may for convenience be divided into four groups:
• elements of offences that establish liability for violating the rules for trading in medical products, retailing (wholesaling) medicines or selling poor quality or counterfeit medication (fines of RUB 20,000-100,000);
• elements of offences that establish liability for medical professionals and heads of medical organisations in relation to regulations covering a conflict of interests (fines of RUB 3,000-10,000)
• elements of offences that establish liability for medical organisations in the area of implementing the state guarantee programme for free medical assistance to individuals (fines of RUB 10,000-30,000);
• elements of offences that establish liability for failing to comply with Rozdravnadzor’s requirements or preventing this state agency or its officials from exercising their powers (fines of RUB 20,000-70,000).
Therefore, it is presumed that Roszdravnadzor will now obtain a sufficient set of tools to encourage companies to comply with its requirements and to normalise the situation on the market of pharmaceutical and medical products.
On 25 November 2013, the Law was published on the official internet portal for legal information (www.pravo.gov.ru); it came into force from the date when it was published, except for the amendment specified in clause 3 of this alert; these will come into force on 1 January 2014.
What to think about, what to do
In connection with these new amendments, we recommend that internal regulations and corporate contracts be brought into line with the legislation, namely that:
1. Effective policies, internal regulations and corporate contracts that set out the procedure for liaising with medical (pharmaceutical) professionals be analysed and amended (if this has not been done yet).
2. Based on amended policies, a standard set of provisions be developed so that they may be included in all corporate contracts signed for future periods (or supplements to effective contracts).
3. A check be made of how the company organises (finances) academic events and other events aimed at enhancing the professional level of medical professionals to eliminate the risk of violating legislation. If needed, the existing policies, internal regulations and contracts should be amended.
4. An audit be carried out of contracts with contractors for events to be organised and held or for ensuring that the company’s representatives participate in events, to ensure that contractors are familarised in a timely manner with the new version of the company’s policies with regard to organising (holding) events and liaising with medical (pharmaceutical) professionals and to create legal schemes for supervising the actions of contractors.
5. Organisational measures be taken to ensure that information about events organised (financed) by the company is published on a timely basis and that it is subsequently submitted to Roszdravnadzor. Notifications be sent in a free format until the format and the procedure are approved for notifying Roszdravnadzor and third parties of the events.
1. Effective policies, internal regulations and corporate contracts that set out the procedure for liaising with medical (pharmaceutical) professionals be analysed and amended (if this has not been done yet).
2. Based on amended policies, a standard set of provisions be developed so that they may be included in all corporate contracts signed for future periods (or supplements to effective contracts).
3. A check be made of how the company organises (finances) academic events and other events aimed at enhancing the professional level of medical professionals to eliminate the risk of violating legislation. If needed, the existing policies, internal regulations and contracts should be amended.
4. An audit be carried out of contracts with contractors for events to be organised and held or for ensuring that the company’s representatives participate in events, to ensure that contractors are familarised in a timely manner with the new version of the company’s policies with regard to organising (holding) events and liaising with medical (pharmaceutical) professionals and to create legal schemes for supervising the actions of contractors.
5. Organisational measures be taken to ensure that information about events organised (financed) by the company is published on a timely basis and that it is subsequently submitted to Roszdravnadzor. Notifications be sent in a free format until the format and the procedure are approved for notifying Roszdravnadzor and third parties of the events.
Help from your adviser
In connection with these amendments, Pepeliaev Group specialists will be happy to provide you with advice on how the new legislative provisions are to be applied, to analyse the company’s current policies and internal regulations for dealing with medical (pharmaceutical) professionals, to prepare standard provisions for the company’s contracts, to develop legal schemes for supervising the activity of contractors and to reply to questions that may arise in connection with the amendments.