Russia. Anna McDonald and Dmitry Dementyev. Salans

Transcription

1 RUSSIA Russia Anna McDonald and Dmitry Dementyev Organisation and financing of health care 1 How is health care in your jurisdiction organised? Health care in Russia is governed primarily by Federal Law No. 323 on the Foundations of Healthcare for Russian Citizens, dated 21 November 2011 and Federal Law No. 326 on Mandatory Insurance in the Russian Federation, dated 29 November Other important legislation includes Federal Law No. 61 on the Circulation of Drugs, dated 12 April There are three main elements to the Russian health-care system: federal (state) medical institutions state hospitals, research institutions, clinics and polyclinics, pharmacies and drug stores. Federal health care plays a key role in delivering the bulk of medical services to the Russian population; municipal (state) institutions, also consisting of medical organisations, pharmacies, etc; and private institutions such as privately owned clinics, private practitioners and privately owned pharmacies and pharmacy chains. Properly registered and licensed private institutions may offer in-patient and outpatient services. In addition, an individual registered as a sole proprietor may (assuming he or she is properly licensed) engage as a private practitioner in medical or pharmaceutical activities. Medical and pharmaceutical activities in Russia may be carried out only on the basis of a respective licence. Such licence must be obtained by a medical or pharmaceutical company or by an individual doctor or pharmacist if such doctor or pharmacist is carrying out medical or pharmaceutical activities in its own name on an individual basis (ie, as an individual entrepreneur). 2 How is the health-care system financed in the outpatient and in-patient sectors? Russian health care (both outpatient and in-patient sectors) is financed through subventions from the federal budget; funds from municipal budgets; money from the mandatory medical insurance fund that consists of contributions from employers and budgetary allocations for the unemployed; and income of medical institutions authorised under relevant laws and regulations. The law permits other miscellaneous funding sources such as charitable donations. Russian health care in effect provides universal coverage and guarantees provision of the following services free of charge: primary public health care (both outpatient and in-patient); emergency services, including specialised medical care (eg, air ambulances); and high-tech and other specialised medical care for illnesses requiring special diagnostics and treatment. Free-of-charge medical care for Russian citizens is provided by state and municipal health-care institutions in accordance with mandatory medical insurance programmes. In the event of illness, incapacitation, or in certain other cases, Russian citizens are entitled to free social and medical care, which may include temporary incapacity benefits. An individual can seek additional medical services on the basis of voluntary medical insurance programmes, paid for either by his or her employer or by the individual him or herself. As stated in question 1, private medical organisations receive their income primarily in the form of fees charged to patients, but may also be paid by the state if they provide medical services to patients entitled to receive treatment paid by the state budget (eg, renal care services). Compliance pharmaceutical manufacturers 3 Which legislation governs advertisement of medicinal products to the general public and health-care professionals? Advertisement of medicinal products in Russia is governed by the following laws: Federal Law No. 38-FZ on Advertising dated 13 March 2006, as amended (the Law on Advertising); Federal Law No. 61-FZ on Circulation of Drugs dated 12 April 2010, as amended (the Law on Circulation of Drugs); and Federal Law No. 135-FZ on the Protection of Competition dated 26 July 2006, as amended (this law contains provisions on unfair advertising and competition) (the Law on Competition). The Law on Advertising contains special requirements for and restrictions on advertisement of pharmaceutical products, medical equipment and medical services, including methods of treatment, particularly if it is placed in the mass media or directed at the general public. These restrictions are further detailed in the Law on Circulation of Drugs. In addition to statutory requirements, the member companies of the Association of International Pharmaceutical Manufacturers (AIPM), a non-commercial professional organisation of international pharmaceutical manufacturers active in Russia, have drafted and adopted a Code of Marketing Practice, which contains various commitments and covenants (including on advertising and marketing practices) that AIPM members have agreed to abide by. These requirements and commitments are not legally binding and amount to voluntary moral undertakings. 4 What are the main rules and principles applying to advertising aimed at health-care professionals? The requirements for advertising aimed at health-care professionals are less strict than for those addressed to the general public. The following advertising to health-care professionals is allowed, assuming the advertising is carried out exclusively at venues for medical or pharmaceutical exhibitions, fairs, seminars, conferences and other such events, or appears in specialised publications for medical and pharmaceutical professionals: 1

2 RUSSIA advertising of medicines in dosages prescribed by doctors, treatment methods, medical purpose items and medical equipment that require special training for their use; advertising of medicines that contain restricted narcotic or psychotropic substances that can be used for medical purposes; and advertising that would otherwise be prohibited because it may: contain references to specific examples of health improvements linked to use of the advertised product; show individuals expressing gratitude for the advertised product; or fail to include warning language (described in greater detail in question 5) concerning possible side effects associated with the use of the advertised product. 5 What are the main rules and principles applying to advertising aimed at the general public? Advertisements (of pharmaceutical products, medical services and medical equipment, including treatment methods) aimed at the general public must be accompanied by adequate warning language regarding side effects and the need to read the instructions or consult a specialist doctor. Such warnings or recommendations must amount to not less than three seconds for radio advertisements, not less then five seconds and 7 per cent of the screen space for television, cinema and video commercials, and not less than 5 per cent of the area of any written advertisement distributed in any other form. An advertisement of a pharmaceutical product (drug) aimed at the general public must not: be addressed to minors (ie, persons under 18); refer to specific cases of curing the disease or improving health condition due to the use of the advertised product; include individuals expressing gratitude for the effect of the advertised product; create a positive impression about the benefits of the advertised product by referring to the results of the clinical and other trials performed as requirement for the registration of such product; assert or assume that the target audience of the advertisement may suffer from certain diseases or health disorders; create an impression that a healthy person should use the advertised product; imply that it is not necessary to consult a doctor in order to use the advertised product; guarantee positive effects of the advertised product, its safety, efficiency and absence of side effects; present the advertised pharmaceutical product as a biologically active supplement or food supplement, or any other nonpharmaceutical product; contain assertions that the natural origin of the advertised product guarantees its safety or effectiveness. Advertising promotions involving giveaways of pharmaceutical products containing narcotic and psychotropic substances are prohibited. 6 What are the most common infringements committed by manufacturers with regard to the advertisement rules? The most common infringements concern failure to provide warnings about possible side effects or about the need to read instructions or consult a physician. 7 Under what circumstances is the provision of information regarding off-label use to health-care professionals allowed? Russian law does not regulate the procedure for providing information on the off-label use to health-care professionals. Therefore, such information may be conveyed to them by any lawful means, including in monographs, professional research articles, professional guidebooks, conferences or roundtable reports, as well as through meetings with health-care professionals. However, it should be noted that all information about properties and characteristics of drugs and medical equipment must correspond to the information contained in the product s pre-approved instructions (leaflet) for use and application. This means that all advertising and marketing materials for a pharmaceutical product must reflect the information contained in the product s instructions. Any deviation in the circulated information about the product and the instructions for its use shall be considered as contradiction to the instruction for the product s use and application, and the competent authorities may demand it be brought into full compliance with the pre-approved instructions for use and application. According to the relevant procedures for prescribing the drugs approved by the Russian Ministry of Healthcare and Social Development (MOH): the off-label use of any drug for an out-patient is directly prohibited and the doctor is personally liable for the breach of this prohibition (such liability may include compensation of damages as well as deprivation of the right to work as a doctor for a certain number of years); and the off-label use of any drug for an in-patient must be preapproved by a special commission to be created for this purpose within the respective health institution. 8 Which legislation governs the collaboration of the pharmaceutical industry with health-care professionals? Do different rules apply regarding physicians in the in-patient and outpatient sector? Relations and interaction between health-care professionals and the pharmaceutical industry are now covered under articles 74 and 75 of the Federal Law No. 323-FZ on the Foundations of Healthcare for Russian Citizens (the Law on Foundations of Healthcare). These provisions came into force on 1 January Article 74 of the Law on Foundations of Healthcare prohibits medical and pharmacy employees from: accepting gifts, cash, paid entertainment, vacation, or travel, companies manufacturing or distributing medicines or medical equipment; entering into written or oral agreements with companies manufacturing or distributing drugs or medical equipment, concerning the prescription or recommendation of certain drugs or equipment to patients; receiving medicine or medical equipment samples from those companies to give away to patients; and providing false or incomplete information on the number, type and name of alternative medicines or medical equipment that may be used in lieu of the prescribed medicine or piece of medical equipment. More importantly, article 74 prohibits one-on-one visits of medical representatives of those companies to medical professionals or treating physicians. The narrow exceptions to the above prohibitions include medical professionals participation in educational programmes and visits, if sanctioned by a hospital s administration or conducted in the course of clinical trials. Article 75 of the Law on Foundations of Healthcare includes a definition of conflict of interest whose apparent aim is to address certain situations not covered by the prohibitions contained in article 74. Under the definition, if a medical or pharmaceutical employee feels (presumably, in his or her sole discretion and acting in best faith, but the law lacks this guidance) that his or her interactions with a company s medical representative (and the material benefits flow- 2 Getting the Deal Through Life Sciences 2012

3 RUSSIA ing therefrom) may affect the quality of care provided by such medical or pharmaceutical employee to a patient or customer, a conflict of interest is deemed to exist and it must be reported as described below. In the event of a conflict of interest, the affected medical professional must report the conflict to his or her superiors, who in turn should refer the details to a special federal agency responsible for resolving such situations (most likely, the MOH will perform this function). Article 75 is widely viewed as having been drafted primarily to address the problems that may arise in the context of clinical trials, to prevent the individual investigator leading the clinical trial programme and receiving remuneration from the sponsor company from participating in the ethical expert examination of such product which must be totally impartial. The law does not distinguish between access to doctors engaged in the in-patient as opposed to outpatient sector. The above rules and restrictions equally apply to both sectors. 9 What are the main rules and principles applying to the collaboration of the pharmaceutical industry with health-care professionals? In addition to the rules and restrictions set out in articles 74 and 75 of the Law on Foundations of Healthcare, the main rules and principles of cooperation between doctors and pharmaceutical companies are set out in the Doctors Code of Ethics of the Russian Federation, adopted by the medical community in 1997 (the Code) (the Code is non-mandatory and additional to the applicable laws and regulations). In particular, the Code states that: [A] doctor shall not accept incentives from manufacturers or distributors of pharmaceutical products for the prescription of their products. A doctor shall prescribe medicines strictly on the basis of medical factors and solely in the interests of the patient. Regarding collaboration between the medical community and foreign pharmaceutical companies, the AIPM Marketing Code of Practice provides basic principles for such collaboration, providing, in particular, that such collaboration: should be aimed at informing health-care professionals of pharmaceutical products, providing them with scientific and educational information, and supporting scientific research in medicine and medical education; avoid causing conflicts of interest, with regard to professional obligations, on the one hand, and economic interests, on the other hand; must not involve pharmaceutical companies offering, promising, providing or giving health-care professionals any kind of remuneration for prescribing or recommending certain pharmaceutical products to patients; supporting professional training, (including sponsoring participation in conferences and other professional events, as well as issuing grants, stipends, and subsidies); and should not be made contingent on the amount of a pharmaceutical product prescribed or sold. 10 What are the most common infringements committed by manufacturers with regard to collaboration with health-care professionals? As the provisions of the Law on Foundations of Healthcare have come into force only recently, no statistics on infringements are available. However, the Federal Antimonopoly Service (FAS) has stated that one of the main infringements repeatedly committed by pharmaceutical companies are improper marketing policies and practices that have led to the creation of material dependency between certain pharmaceutical companies and health-care professionals overwhelmingly prescribing such companies drugs to patients. Simply put, the practice of gift giving is so widespread in the health-care industry that it is said that practitioners get their salaries not from their employers, but from the pharmaceutical or medical device manufacturers. State regulators point out that this material dependency is certain to have a significant negative effect on the practitioners ability to exercise their objective professional judgement when prescribing treatments to patients. 11 What are the main rules and principles applying to the collaboration of the pharmaceutical industry with patient organisations? Patient organisations are relatively new in Russia and to date there is no legal or regulatory framework governing their relationship with the pharmaceutical industry. The rights of individual patients in relation to pharmaceutical companies are more developed. According to the Russian Declaration of Patients Rights, adopted in May 2010: [E]very person has the right to direct access to information on scientific research, the possibilities of pharmaceutical therapy, and technological innovation. This information may be provided by public or private sources, provided it meets criteria for accuracy, reliability, and transparency. Rules are also set out in the AIPM Marketing Code of Practice, which states, in particular, that when a patient asks a pharmaceutical company for information, such requests must be satisfied. Again, the aforementioned rules are not mandatory and represent mere recommendations for the AIPM members. 12 Are manufacturers infringements of competition law pursued by national authorities? FAS is in charge of enforcing Federal Law No. 135-FZ on the Protection of Competition dated 26 July 2006 and has been very active in prosecuting violations on the pharmaceutical and medical equipment markets. Most violations relate to selective distribution and alleged attempts to restrict access to product markets for new participants. A growing number of violations concern agreements or concerted actions among distributors, designed to drive prices either down or up if product sales occur via state procurement procedures as envisaged in the Federal Law No. 94-FZ on Placement of Orders for the Supply of Goods, Performance of Works or Rendering Services for State and Municipal Needs, as amended (the Law On State Orders). 13 Is follow-on private antitrust litigation against manufacturers possible? No. The FAS is in charge of enforcement of antitrust law provisions Accordingly, a private person (individual or a company) may only file a complaint with the FAS against a manufacturer allegedly breaching antitrust law requirements. The FAS may, upon consideration of the complaint, impose a fine or seek invalidation of the transaction through court proceedings. Compliance medical device manufacturers 14 Is the advertising of medical devices and the collaboration of manufacturers of medical devices with health-care professionals and patient organisations regulated as rigorously as advertising and collaboration in the pharmaceuticals sector? The advertising of medical devices and equipment is less regulated than advertising of pharmaceutical products. However, it would be fair to say that state enforcement authorities pay equal attention to both. Nonetheless, given the social significance of the issue of availability of affordable and quality medicines and therefore the need to ensure free and fair competition at all levels of the supply chain, the pharmaceutical sector in general receives greater attention from the FAS, greater media coverage and, therefore, produces a greater number of well-known precedents. 3

4 RUSSIA As regards the collaboration of manufacturers of medical equipment and devices with health-care professionals compared with collaboration of manufacturers of pharmaceutical products, both are regulated to an equal degree by articles 74 and 75 of the Law on Foundations of Healthcare, as more fully described in question 8 above. Pharmaceuticals regulation 15 Which legislation sets out the regulatory framework for granting marketing authorisations and placing medicines on the market? The Law on Circulation of Drugs allows a drug to be imported into Russia (except for a few very limited cases) and sold on the market to the general public only if it has been registered with the MOH. The Law provides a procedure for registering and issuing registration certificates for pharmaceutical preparations and drugs. The Law also requires that the maximum manufacturer s price for a vital and essential drug be registered with MOH as a prerequisite for placing such drug on the market. 16 Which authorities may grant marketing authorisation in your jurisdiction? As of 1 September 2010, pharmaceutical products are registered in Russia by the Department for Regulation of Medicinal Products of the MOH. 17 What are the relevant procedures? In accordance with the Law on Circulation of Drugs, the procedure for the registration of a new drug consists of the following stages: pre-clinical trial of a drug; filing an application for state registration of the pharmaceutical product; arranging and conducting expert examination of documentation to obtain a permit for the product s clinical trials; arranging and obtaining a positive finding from the ethics committee for the conduct of the product s clinical trials; arranging and conducting expert examination of the documents submitted for further approval of clinical trials and ethical expert examination; clinical trials of the product carried out by one of the health-care institutions specifically accredited by the MOH for this purpose; and quality assessment of the product (ie, an expert assessment of proposed quality control methods and quality of product samples using the said methods) and expert risk-benefit assessment of the medicines subject to clinical trials. A decision on the pharmaceutical product s state registration is made on the basis of the results of the above assessments and trials. The Law on Circulation of Drugs requires that the process of state registration of a pharmaceutical product is completed within 210 days, excluding the time required for carrying out clinical trials and the time necessary to produce the relevant documentation. The registration certificate for a medicine must describe the medicine form and dosage. A registration certificate for a medicine registered in Russia for the first time is issued for five years. Following the expiry of the initial five-year term, the registration of the medicine must be confirmed under a separate expedited procedure, described in detail in article 29 of the Law on Circulation of Drugs, which involves, among others, proving the quality of the medicine: if proved positive, the registration for such medicine is granted and the registration certificate is issued for an indefinite period of time. Following state registration, registered medicines are listed in a special state register of medical products, in accordance with article 33 of the Federal Law on Circulation of Drugs. 18 Will licences become invalid if medicinal products are not marketed within a certain time? Are there any exceptions? The Law on Circulation of Drugs does not condition the validity of the state registration of a pharmaceutical product by the marketing or sale of a product within a certain time frame. However, for a branded product, the failure to market or sell it within three years of registration of the respective trademark in Russia creates a risk to have such trademark s registration cancelled and, consequently, the possibility for any person to register such trademark in their own name. 19 Which medicines may be marketed without authorisation? Pursuant to article 13 of the Law on Circulation of Drugs, state registration is not required for: pharmaceutical products manufactured on-site by pharmacies, veterinary pharmacies or by individual entrepreneurs licensed as pharmacists, according to prescriptions and requirements of medical organisations, or veterinary organisations; medicinal plant products; drugs acquired by individuals outside Russia and intended for personal use; medicines intended for export; or radiological drugs manufactured by medical organisations in accordance with applicable laws and regulations. 20 Are any kinds of named patient programmes in place? If so, what are the requirements for pre-launch access? The Federal Law on the Circulation of Medicines allows for so-called named patient supply programmes. Specifically, a state-owned federal hospital may decide to use a medicine that has not been registered in Russia. The medicine must be intended for a particular patient. The decision must be adopted by a special hospital consultation board and should specify, in particular, the amount of the unregistered medicine that is necessary for treatment. The decision is then passed on to Federal Control Service for Healthcare and Social Development (Roszdravnadzor) in the form of an application for approval. The application should ordinarily contain a completed application form, the patient s written consent for the treatment, a copy of the consultation board s decision and a copy of the quality certificate for the requested medicine. Roszdravnadzor must make a decision within five days of the application. Once Roszdravnadzor approves the application, the hospital may proceed to purchase the medicine from a foreign manufacturer and import it into Russia. Pricing and reimbursement of medicinal products 21 To what extent is the market price of a medicinal product governed by law or regulation? Pursuant to article 61 of the Law on Circulation of Drugs, the maximum sale price for any vital or essential drug must be registered with the MOH. Each year, the Russian government approves the list of vital and essential drugs (based on their international non-patented name (INN)) (EDL) for the upcoming calendar year. If a medicine is included in the EDL, its maximum sale price that the foreign supplier (for imported drugs) or domestic manufacturer (for locally produced drugs) may charge to the first distributor is subject to mandatory registration with the MOH, based upon the economic case presented by the supplier. If the drug is not on the EDL, the supplier may establish the sale price at its sole discretion. The wholesale and retail margins for drugs included on the EDL are also regulated in that the maximum wholesale and retail mar- 4 Getting the Deal Through Life Sciences 2012

5 RUSSIA Update and trends Given the fairly recent enactment of the two fundamental laws, the Law on Circulation of Drugs and the Law on Foundations of Healthcare and a number of controversial provisions in each of them, the Russian pharmaceutical market is looking forward to their interpretation and enforcement by the competent governmental authorities. Among legislative initiatives currently under consideration by the State Duma (Russian Parliament) are draft amendments to the Law on Advertising making requirements for advertising of pharmaceutical products, nutrients and methods of medical treatment more stringent as well as amendments to the Russian Criminal Code providing for criminal liability for manufacturing, sale, storage, transportation and import into Russia of counterfeit pharmaceutical products and nutrients. However, all of these amendments are at the very beginning of the approval process, so at present it is premature to comment on their exact provisions. gins for such drugs are established by regional authorities for their respective region. The typical maximum wholesale margin is 15 per cent and the typical retail margin is 25 per cent, although higher thresholds may apply in regions requiring additional market stimulus (eg, Far North regions). If the drug (INN) is not included on the EDL, none of the above pricing restrictions will apply. 22 Must pharmaceutical manufacturers negotiate the prices of their products with the public health-care providers? No. A manufacturer is not required to negotiate the maximum sale price for an EDL drug with public health-care providers in order to register such price with the MOH as described above. The registration is made on the basis of the economic case showing, in particular, the sale price charged by the manufacturer in other countries for the same product. Regarding the actual price the manufacturer or foreign supplier charges the distributor, public health-care providers usually do not interact with the manufacturers and foreign suppliers of pharmaceutical products directly. The public health-care providers submit a request for relevant drugs to the respective health-care authority (regional or federal), which then organises the tender for the supply of the relevant drugs and subsequently purchases directly the drugs from the supplier (normally, the Russian distributor). Thus, the prices of pharmaceutical products supplied by private companies to public health-care providers are determined in the course of state procurement procedures carried out by the respective authorities. These procedures must comply with the Law on State Orders and respective regulations. In particular, a reverse tender or auction mechanism is normally used for determining the ultimate purchase price where the registered maximum price for an EDL drug is the starting point, and the bidder who offers the lowest price wins the auction. As the EDL is rather broad, virtually all auctions organised by the competent authorities cover EDL drugs only and thus the registered price for the respective EDL drug is the starting point in such tenders. A non-edl drug can only be supplied to a public health-care provider through an auction or tender (this is a mandatory requirement of the Law on State Orders. The bidder offering the lowest price should win the tender or auction. The FAS is clamping down on regional authorities to eliminate the practice of rigging state tenders and auctions, with the result that only one bidder can qualify. Similarly, FAS has initiated a few antitrust proceedings against certain Russian distributors, accusing them of concerted actions in the context of state tenders, with the result that only one distributor participated in the auction with the highest price and therefore won it, to the detriment of the public interest. These cases of concerted actions, in turn, resulted in the opening of criminal proceedings against the top managers of some of those distribution companies. 23 In which circumstances will the national health insurance system reimburse the cost of medicines? The Russian mandatory medical insurance system provides for a limited reimbursement of the cost of medicines, as described below. In-patient care EDL medicines (see question 21) are provided for free regardless of the duration of treatment. If a patient is prescribed non-edl drugs, either he or she must purchase such medicine or if the medicine is not yet registered in Russia in theory, have it purchased by the hospital in the manner described in question 20 above. Outpatient care The reimbursement of EDL medicines depends on the patient s category and nature of illness. Specifically, some classes of patients (for example, World War II veterans, Heroes of the Russian Federation and children up to three years of age) are entitled to obtain prescription drugs at no charge, other categories (for example, non-working class II disabled, and pensioners receiving a minimum pension) have to pay 50 per cent of the retail price of the prescription drugs. The list of persons qualifying for such benefits is established by Federal Law No. 178-FZ dated 17 July 1999 on State Social Care and Government Resolution No. 890 dated 30 July 1994 on State Support for the Development of the Medical Industry and Improvement in the Supply of Medicinal Products and Medical Devices to the Public and Health-care institutions. In addition, a person is entitled to free EDL drugs if such person suffers from certain specific diseases (established by law) such as HIV, cerebral palsy, cancer, and tuberculosis. 24 If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products? The Russian government approves the EDL on an annual basis. A draft of the EDL is prepared by the MOH. Accordingly, the medicines included in EDL are subject to pricing restrictions and reimbursement principles described above. The MOH approves the methodology for pharmaceutical producers to set maximum manufacturers prices for medicinal preparations on the EDL. The Federal Tariff Service approves the methodology for regional executive authorities to set the maximum wholesale and resale markups on actual sale prices set by manufacturers of EDL drugs. 25 Are manufacturers or distributors of medicinal products statutorily obliged to give a discount? Neither manufacturers nor distributors are obligated to provide any special discount on medicinal products. However, discounts or bonuses may be freely negotiated in the context of a specific contract such discount policies are widely used as a form of sales stimulation. 5

6 RUSSIA Medicine quality and access to information 26 What rules are in place to counter the counterfeiting and illegal distribution of medicines? The production, importation and sale or distribution of counterfeit pharmaceutical products and low-quality medicinal substances is prohibited in Russia. To ensure medicines imported and sold in the country are of high quality, Russian laws and regulations set out stringent licensing requirements that manufacturers, importers and retailers must abide by, such as: for manufacturers the licensee s compliance with rules on the production of medicinal products; and for wholesalers and pharmacies the licensee s compliance with requirements that prohibit the sale of medicines that have lost effectiveness, medicines with expired shelf-life dates, etc. Violation of the aforementioned obligations may lead to the suspension or cancellation of a pharmaceutical licence (be it for manufacturing, or wholesale or retail sale). The importation and distribution of fake and counterfeit medicinal products may also be qualified as infringement of IP right with possible criminal sanctions, in addition to damages which may be awarded to an aggrieved party through a court action, as well as administrative penalties (usually, in the form of fines). 27 What recent measures have been taken to facilitate the general public s access to information about prescription-only medicines? Unlike in EU countries, there has not been any tangible effort aimed at facilitating the general public s access to information about prescription medicines. In accordance with article 67 of the Federal Law on the Circulation of Medicines, information on prescription medicines should appear only in specialised publications intended for medical, pharmaceutical, and veterinary professionals. As mentioned previously, public advertising of such medicines is prohibited. 28 Outline major developments to the regime relating to safety monitoring of medicines. Pursuant to article 64 of the Law on Circulation of Drugs, all market participants involved in the sale and distribution of drugs must disclose and report to the MOH any and all information about possible adverse effect of the drugs sold or distributed by them if and when such information becomes known to them. Failure to disclose the information about adverse health effects may lead to administrative or criminal liability. Anna McDonald Dmitry Dementyev amcdonald@salans.com ddementyev@salans.com Balchug Plaza 7 Tel: Balchug Street Fax: Moscow Russia 6 Getting the Deal Through Life Sciences 2012