Life Sciences in 25 jurisdictions worldwide 2013

Organisation and financing of health care

• How is health care in your jurisdiction organised?

The current Romanian health-care system was set by Law No. 95/2006 regarding the reform of the health-care system (Health Care Law), which creates the legal framework for the organisation and financing of the health-care system.

The Ministry of Health (MoH) and the National Health Insurance House (NHIH) are the main administrative bodies in charge of health care matters. MoH has strategic, regulatory, coordination and monitoring functions in most health-care areas. The NHIH is the body with strategic functions regarding the public national health insurance fund. It is also responsible (starting from 2012) for the management of the national electronic health-care card system. Both authorities have a pyramidal structure, with decentralised services in each county.

In practice, the national health insurance fund system is severely under-financed, with the consequence that public health-care facili- ties do not always have the necessary resources for treatment under the public insurance system.

Another important public authority is the National Authority for Medicines and Medical Devices (NAMMD), subordinated to the MoH and enjoying large prerogatives regarding the authorisation of medicinal products and medical devices.

Other professional agencies and associations also play an impor- tant role in the administration of the health-care system.

Public health services are provided by hospitals and other health- care facilities.

 

 

• How is the health-care system financed in the outpatient and in-patient sectors?

Both outpatient and in-patient health-care services can be provided by public or private health-care facilities. Certain exceptions exist (for example, private investors cannot establish hospitals exclusively dealing with emergency cases).

The national public health insurance is mandatory for all Roma- nian citizens and foreign residents in Romania. A significant contri- bution (as a percentage from the overall revenue) is paid by both the employer and the employee. Every insured person has the theoreti- cal right to receive a quite substantial basic package of services and products (medicines, medical devices), provided that such person has been accepted by a ‘family doctor’.

Persons not insured with the public system can benefit from a minimal package of services, limited mainly to medical emergencies, prevention and cure of epidemic risks, pregnancy monitoring and delivery, and family planning.

Public health-care facilities may carry out services on the basis of direct payment or copayment from patients.

Private health-care facilities can become affiliated with the NHIH and in such case they may receive repayment of the basic package of health-care services and products. Private health insurance is also available from various private insurers.

The treatment or prevention of certain rare or severe diseases (eg, diabetes, multiple sclerosis, cancer, etc) are covered under various national health-care programmes and are theoretically, to a large extent, free of charge.

Compliance – pharmaceutical manufacturers

• Which legislation governs advertising of medicinal products to the general public and health-care professionals?

General rules on the advertisement of medicinal products are laid down in title XVII, chapters VIII and IX of the Health Care Law. Advertising includes the provision of any type of information, prod- ucts (samples) or funds (sponsorships) by a manufacturer (or with the manufacturer’s approval) destined to stimulate the prescription, distribution, sale or consumption of medicinal products.

More particular regulations on the advertisement of medicinal products are provided within the Guide for the evaluation of the advertisement for medicines for human use (Advertising Guide) issued by the NAMMD Scientific Council (No. 21/2011) abolishing the former NAMMD Scientific Council Guide No. 21/2010. The Advertising Guide has been designed to comply with EU Directive No. 92/28/EC regarding the advertising for medicinal products for human use. Under these rules, advertising consists of any activity ini- tiated, organised or sponsored by a pharmaceutical supplier aiming at encouraging the prescription, the release, the sale, the administra- tion or the consumption of a medicinal product. The Advertising Guide and the NAMMD practice seem to mainly regard the adver- tising made by manufacturers of medicines and are not consistent or clear regarding the advertising activities initiated and carried out by entities other than suppliers (ie, distributors, pharmacies).

As a general rule, the advertising for medicinal products exclu- sively sold under medical prescription or which are not covered by a valid marketing authorisation in Romania is prohibited. It is man- datory for all the information from the advertising material for a specific medicinal product to mirror the information on the Sum- mary of the Product Characteristics. The Advertising Guide excludes from its scope the donation of medicines, which cannot be supplied for marketing purposes. The conditions and the limits regarding the donations of medicinal products and medical devices are set out by specific regulations from June 2011.

The NAMMD is the domestic authority in charge with the moni- toring of the advertising activities on the Romanian market. The release of advertising materials for over-the-counter medicinal prod- ucts is subject to prior approval by the NAMMD. Non-compliance with legal requirements on advertising for medicinal products by manufacturers or distributors is subject to fines and other penalties provided by the law.

 

• What are the main rules and principles applying to advertising aimed at health-care professionals?

In accordance with the Health Care Law and the Advertising Guide, promotional materials for medicinal products destined to health-care professionals must include at least the following: essential informa- tion compatible with the respective product’s characteristics; the classification for the release of that product; and information on the advertising documentation’s date and last updates. All information in the advertising documentation must be sufficiently accurate, updated and complex as to allow any health-care professional to understand the medicinal product’s therapeutic use.

The Advertising Guide adopts a broad position on who may enter the category of health-care professionals. Together with the personnel qualified to prescribe or release medical products, profes- sionals that can encourage the purchase, sale and the consumption of medicinal products are also caught by the Advertising Guide.

Advertising for health-care professionals must not be carried through unethical means, such as offering, granting or promising gifts, pecuniary or material advantages. Health-care professionals are however allowed to receive inexpensive advantages that are related to medical or pharmaceutical activity.

Rules on the advertising for health-care professionals are also detailed in the Code for an Ethical Advertising of Medicinal Prod- ucts issued by the Romanian Association of International Produc- ers of Medicinal Products (ARPIM Ethical Advertising Code). The ARPIM Ethical Advertising Code includes detailed guidelines on specific advertising activities for health-care professionals, such as: transparency conditions for advertising campaigns, hospitality and sponsorship for health-care professionals, the distribution of samples of medicinal products, etc. The ARPIM Ethical Advertising Code does not enjoy legal force.

 

• What are the main rules and principles applying to advertising aimed at the general public?

Any advertising material aimed at the general public must state clearly that the product is a medicinal product and shall include information on:

• the medicinal product’s name and the corresponding active ingredient;
• instructions regarding the proper utilisation of the product; and
• a clear and express invitation for the consumer to read all instruc- tions on the product’s

 

Such advertising cannot:

• suggest that medical consultation is not needed;
• suggest a guaranteed treatment or improvement of the health status or suggest that the health status might worsen if that par- ticular medicine is not used;
• compare medicines;
• address to children;
• rely on endorsement made by health-care professionals or notori- ous persons;
• suggest that the medicine is food, cosmetic or other consumer product; or
• suggest the safety or efficiency of the product due to its natural components,

 

No advertising activity aimed at the general public can be carried out regarding:

• medicinal products sold under medical prescription;
• medicinal products containing narcotic ingredients; and
• medicinal products sold under medical prescription released in the public health insurance

 

In addition, pharmaceutical suppliers are prohibited from directly distributing medicinal products (samples) to the general public.

Advertising of medicinal products for the general public containing

commercial offers (eg, ‘buy one, get one free’ offers, discounts, tying sales) or references to prices, discounts or any other type of price reductions, are unlawful.

The NAMMD adopted a quite restrictive approach regarding the materials that can be used for advertising within pharmacies. The NAMMD also sets out extensive description of requirements and restrictions for the display of each type of advertising material.

• What are the most common infringements committed by manufacturers with regard to the advertising rules?

The NAMMD statistics show that most frequent infringements regarding the advertisement rules were price-related or promotional campaigns, advertising of prescription-only medicinal products, dis- tribution of unauthorised advertising materials, comparative adver- tising, the carrying out of TV, radio or outdoor advertising without, or by exceeding the limits of, the NAMMD’s prior approval. No sanction was applied for unlawful advertising by e-mail or by other promotional means via the internet. However, the NAMMD’s increased interest in this type of advertising is visible from the very extensive regulation of internet and e-mail activities within the Advertising Guide.

In NAMMD practice, penalties are applied mostly to the market- ing authorisation (MA) holders, even though, in fact, the infringe- ments may have been carried out by distributors or pharmacies without any contribution from the manufacturers. In January 2011, the NAMMD announced that legal sanctions had been applied to approximately 20 manufacturers for infringements of advertisement rules exclusively committed by pharmacies. The most common infringements consisted in the retail sale of promotional packages containing three different branded products sold at special prices as well as the carrying on of advertising activities for prescription-only medicines. Also, in July 2011 the NAMMD sanctioned a local manu- facturer for broadcasting a TV spot going against the version that had been previously approved, while in January 2012 the NAMMD ordered the withdrawal of advertising materials for several medicines inappropriately distributed to health-care professionals.

Given the relative frequency of infringements of the Advertis- ing Guide, the NAMMD has decided to strictly regulate the size, features and presentation of advertising materials (eg, shelf talkers, wobblers, stoppers, counter displays, floor stickers, posters, dummy boxes, ceiling hangers, flyers, banners, newsletters, etc) in compliance with advertising rules.

• Under what circumstances is the provision of information regarding off- label use to health-care professionals allowed?

As a general rule, manufacturers or health-care professionals are precluded from using off-label information that would result in the advertising of a medicinal product for unauthorised uses or utilisa- tion of a medicinal product under different conditions than the ones provided by the summary of the product characteristics. Advertising for off-label use of medicinal products is solely allowed as a response to a health-care professional request.

• 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?

The provisions of the Health Care Law (articles 802 to 807, title

XVII) refer only to advertising rules for health-care professionals. The legislation does not provide a consistent set of specific rules on the wider collaboration between the pharmaceutical industry and the health-care professionals.

 

The ARPIM Ethical Advertising Code sets forth the conditions and the limits of sponsorships offered to health-care professionals, while prohibiting the offering of any personal gifts to any health-care professional. As these rules do not enjoy legal force, ARPIM is cur- rently lobbying the MoH for the introduction of mandatory rules. The MoH publicly announced in July 2010 that negotiations are being carried out with health-care authorities and the pharmaceutical industry, but to date no such rules have been passed.

The existing rules on the collaboration of the pharmaceutical industry with health-care professionals do not seem to be applied differently for physicians in the in-patient and outpatient sectors.

• What are the main rules and principles applying to the collaboration of the pharmaceutical industry with health-care professionals?

The advertising rules contain the following general principles regard- ing such collaboration:

• health-care specialists enjoy freedom to prescribe medicines in accordance with their individual professional belief;
• pharmaceutical suppliers may conclude consultancy agreements for professional medical recommendations, with no possibility for industry players to interfere with doctors’ prescription prac- tice independence;
• health-care professionals cannot be offered, promised or pro- vided any gift, financial advantage or other benefits as an incen- tive to prescribe, purchase, provide, sell or administer a Only inexpensive gifts can be offered or given to health-care pro- fessionals (a value not exceeding €40);
• the sponsorship of an event or a health-care professional par- ticipation at conferences should always be a publicly available information;
• a supplier may not pretend the promotion or its medical prod- ucts’ acquisition in exchange of advantages granted to health- care professionals. The sponsorship must not exceed those expenditures strictly related to the medical event; and
• the law also limits the number of free samples of medicines that a health-care professional can receive from suppliers in a promo- tional campaign for

• all partnerships between the industry players and the patient organisations must rely on mutual respect and an equally based decisional position;
• pharmaceutical suppliers cannot pretend to become a patient organisation’s sole finance sources;
• the financial or non-pecuniary support granted by the pharma- ceutical industry to patient organisations must always be clearly made public; and
• hospitality offered to patient organisations’ members must be limited to a reasonable level and strictly connect to the scope of each medical

12 Are manufacturers’ infringements of competition law pursued by national authorities?

Manufacturers’ infringements of both domestic and EU competition rules are pursued by the Romanian Competition Council. The Coun- cil is also competent to examine and indicate where the health-care regulation and practice of the health-care public authorities infringes the competition rules.

There is already a substantial antitrust practice regarding the pharmaceutical industry. Record fines were applied in 2008 for unlawful market-sharing agreements concluded between a major supplier of insulin products and three of its distributors in the con- text of public tenders for the acquisition of insulin for the National Diabetes Programme (Competition Council decision No. 15/2008). Significant fines were also applied to dialysis services and product providers. Also, on the basis of recommendations made by the Com- petition Council, in 2007 the national health authorities switched, in connection to acquisitions for national programmes, from a central- ised system to a decentralised (hospital) system. In 2011 and 2012, the Competition Council fined four large suppliers of prescription- only medicinal products and their distributors for parallel import and export bans imposed on their distributors.

In April 2011, the Competition Council also finalised its sector inquiry report announcing its main competition concerns regard- ing the entire pharmaceutical industry (eg, the organisation of pub- lic tenders by public hospitals, the need for regular public tenders and for objective awarding criteria, generics’ weak penetration of  the Romanian market and the poor accessibility to reimbursement

 

• What are the most common infringements committed by manufacturers with regard to collaboration with health-care professionals?

No accurate public statistical information is available on this matter. A report issued by a commission for the analysis and elaboration of health system politics in Romania issued in July 2008 under the authority of the president of Romania suggests that pharmaceutical suppliers allocate significant resources to influence a physician’s choice of prescription. Marketing and sponsorship concluded with health-care professionals are the preferred methods to give a legal appearance to such arrangements. The report does not suggest that such practices are not within legal limits.

lists for newly marketed medicines). Moreover, in October 2011, the Competition Council restated its main antitrust concerns regard- ing the sector’s breakdowns and submitted these matters to public debate, while further market interventions are probably expected.

At the beginning of 2012, the Council issued a long-awaited decision whereby dealer authorisations, (ie, mandatory state- ments to be submitted by manufacturers) traditionally requested by public hospitals as a qualification requirement for wholesalers attending public tenders, were finally deemed to lead to product fore- closure, while potentially restricting competition between distribu- tors attending public tenders for the acquisition of medicines under health-care programmes (eg, Cluj Emergency Hospital and its public tender for the acquisition of insulin pomp consumables in 2010). The Council has also been particularly interested in the collaboration

 

• What are the main rules and principles applying to the collaboration of the pharmaceutical industry with patient organisations?

The law does not regulate the collaboration between pharmaceuti- cal industry and patient organisations. ARPIM has instead issued a Practice Code regarding the relations between pharmaceutical suppli- ers (ie, ARPIM members) and patient organisations (Practice Code) entered into force as of 1 April 2010.

The Practice Code contains the following principles on the matter:

• industry players must not influence the texts or any other mate- rials circulated by the patient organisations in such a way as to favour their own commercial interests;

between manufacturers and health-care professionals, recommend- ing a more detailed regulation by the MoH for the types of gifts, benefits or hospitality that could be legally granted to health-care professionals (Decision No. 43/27.09.2010).

The Council has also been constantly involving in the health care and pharmaceutical legislative process for ensuring an overall harmonisation with a competition legal framework. The Council has advised the NHIH on the annual Framework Agreement, as well as on the calculation methods of the reimbursement price within the national health-care programmes. As a general strategy, the Com- petition Council confessed not encouraging further reductions of the reimbursement price levels of medicines covered by the national health-care programmes, which would otherwise risk leading to dramatic export increases likely causing supply deficits on the local market. The Council has also been actively involved in the setting-up and reshaping of the local clawback mechanism, while considering that the application of a unitary computation basis for all contribu- tors together with a differentiated approach between innovative medicines and generics would likely enhance a better implementa- tion of the claw-back tax.

 

• Is follow-on private antitrust litigation against manufacturers possible?

Private persons (distributors, competitors, retailers, patients) may theoretically request damages before the national courts for infringe- ments of competition rules by manufacturers. This legal availability is provided within the Romanian Competition Law No. 21/1996, where individuals or legal entities are encouraged to recover dam- ages arising from antitrust practices through claims filled before the relevant civil courts. The deadline for bringing a follow-on action is two years starting from the date when the Competition Council’s sanctioning decision had remained final.

Nevertheless, to our knowledge, no such proceedings exist to date.

 

Compliance – medical device manufacturers

 

• 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?

contain information about the product, the prospect, the Summary of the Product Characteristics, labelling, the quality and quantity characteristics of the product and relevant data on the medicine’s manufacture.

On the basis of the EU Directive on the mutual and decentral- ised recognition procedures, a medicine already marketed in at least another EU member state, can be granted a marketing authorisation by means of a mutual recognition or decentralised procedure.

Under particular conditions, a special simplified authorisation procedure is provided for homeopath medicines and medicinal plants with a traditional use.

The marketing authorisation is refused if the risks-benefits analy- sis is unfavourable, the therapeutic efficacy is not sufficiently proved, or the qualitative and quantitative composition does not conform to the documentation.

A marketing authorisation is valid for five years. An additional renewal occurs when the marketing authorisation holder submits an updated and consolidated version of the authorisation file at least nine months prior to the expiry of the five-year initial validity term. Once renewed, the respective marketing authorisation becomes valid for an unlimited duration, except when the NAMMD decides to limit the reauthorisation duration to five years due to the existence of pharmacoviligance irregularities or if the respective medicine has been used by an insufficient number of relevant patients.

 

The legislation provides no specific rules on the advertising of medi- cal devices or the collaboration of medical devices manufacturers with health-care professionals and patient organisations. It is unclear whether this was a voluntary policy choice due, for example, to the fact that medical devices raise a lesser practical risk of misuse com- pared to medicinal products.

General rules on the advertising of products apply; however, these may be insufficient for medical devices that contain a medicine component.

18 Will licences become invalid if medicinal products are not marketed within a certain time? Are there any exceptions?

The marketing authorisation ceases if a medicine is not put on the market within three years of its authorisation. The same rules apply to authorised medicines previously put on the market and no longer merchandised in Romania for three years consecutively. The law also provides an exception to these rules, when the NAMMD may decide that despite the three-year market absence, exceptional reasons moti- vated by the public interest justify the extension of the marketing authorisation. Such exceptions must be rigorously justified.

 

 

  19 Which medicines may be marketed without authorisation?

 

Pharmaceuticals regulation

 

• Which legislation sets out the regulatory framework for granting marketing authorisations and placing medicines on the market?

The Health Care Law (title XVII, chapter III) sets out the framework for the issuance of marketing authorisations and placing medicines on the market. This procedure is further detailed in the Regulations regarding the marketing authorisation and surveillance of medicinal products (Marketing Authorisation Regulation).

 

• Which authorities may grant marketing authorisation in your jurisdiction?

The competent authority to issue marketing authorisations for medicinal products as well as medical devices is the NAMMD.

The marketing authorisation is not necessary for radiopharmaceuti- cal products prepared by a person or an entity which, according to the national legislation, is authorised to use such medicines pursuing the supplier’s instructions, in accredited medical centres or exclu- sivelyusing radionuclide generators, kits or radionuclide authorised precursors.

Also, a marketing authorisation is not necessary for medicines that are prepared by a pharmacy on the basis of a medical prescrip- tion recipe developed for a certain patient or a pharmacy-own recipe sold exclusively within that pharmacy.

Another product category not covered by the authorisation requirement consists of intermediary products destined to be pro- cessed by an authorised supplier for the manufacture of final medici- nal products.

 

Medicines may also be placed on the Romanian market on the  basis of marketing authorisations issued by the European Medicines Agency pursuant to a centralised procedure.

 

• What are the relevant procedures?

The marketing authorisation procedure before the NAMMD is reserved for those medicines that have not been previously authorised for marketing purposes at EU level. The duration of the authorisation procedure cannot exceed 210 days from the registration of a valid request in this respect. The authorisation documentation is submitted to an evaluation process finalised by a recommendation or rejection of the authorisation. If granted, the marketing authorisation shall

• Are any kinds of named patient (or similar expanded access) programmes in place? If so, what are the requirements for pre-launch access?

Article 699(1) of the Health Care Law transposes into the national legislation article 5(1) of Directive 2011/83/EC regarding the pos- sibility to exclude from the authorisation requirement those medici- nal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his or her direct personal care.

 

 

The conditions for the implementation of such expanded access programmes are further developed by the MoH Order (Order No. 962/2006). The MoH would authorise the supply of medicinal prod- ucts responding to patients’ special needs if:

• a good faith unsolicited order has been made at the prescribing doctor’s initiative with the patient’s consent;
• the respective medicinal product is prescribed by a health-care professional;
• the medicinal product is destined to one or several patients under the prescribing doctor’s direct care; and
• it is distributed by duly authorised wholesalers in compliance with specific regulatory

 

No advertising is allowed in relation to such medicinal products. The NAMMD may consider waiving all obligations related to the pack- aging and labelling conditions for medicines supplied in expanded access programmes.

Data on the expanded access programmes currently authorised by the MoH do not seem to be publicly available. The MoH can also temporarily exceptionally authorise the distribution of medicinal products not covered by a marketing authorisation in the case of sus- pected or confirmed epidemics or the release of chemical or nuclear substances capable of endangering the public health.

 

Pricing and reimbursement of medicinal products

 

• To what extent is the market price of a medicinal product governed by law or regulation?

Manufacturers of over-the-counter (OTC) medicinal products are free to set their products’ sale prices. Manufacturers are however bound to obey free market and competition-related principles.

On the contrary, the prices for prescription-only medicinal products are regulated. MoH sets maximum manufacturer prices, maximum wholesale prices and maximum pharmacy prices for all prescription medicines. All such medicines are listed in the National Catalogue regarding reference prices for medicinal products for human use (CANAMED) reviewed periodically by the MoH (www. ms-preturi.ro).

The reference price is not always fully reimbursed by the NHIH. Government Decision No. 720/2008 set out lists of active substances and provides that reimbursement rates apply to the cheapest medi- cine among those covered by the same active substance (ATC 5 level). This policy obviously favours generic medicines.

 

• Must pharmaceutical manufacturers negotiate the prices of their products with the public health-care providers?

The reference prices of medicinal products eligible for the reimburse- ment lists are at least theoretically the result of negotiations between manufacturers and the MoH. No particular procedures regulate dis- cussions between manufacturers and the MoH.

Manufacturers must notify the intended price to the MoH. As a general rule, the reference price must not exceed the lowest price for the same medicine in a list of EU countries where the medicine

• In which circumstances will the national health insurance system reimburse the cost of medicines?

Government Decision No. 720/2006 sets the following reimburse- ment levels:

• Sub-List A: medicines for the outpatient sector enjoying a 90 per cent compensation level from the minimum reference price by active substance (international common denomination); this sub-list generally regards generics that are significantly cheaper than corresponding patented medicines;
• Sub-List B: certain patented products for which the compensa- tion rate is of 50 per Retired persons with low revenues (below 700 Romanian lei) may benefit from a 90 per cent com- pensation level. The rate applies to the minimum reference price corresponding to the prescribed active substance (international common denomination);
• Sub-List C1: medicines for treatment of severe diseases (heart disease, hepatitis, epilepsy, Parkinson’s disease, etc) have a 100 per cent compensation The rate applies to the minimum reference price corresponding to the prescribed active substance (international common denomination);
• Sub-List C2: medicines covered by the national health-care pro- grammes no longer enjoy a 100 per cent deduction rate applied to each medicine’s actual market price; the current reimburse- ment rate for these medicines cannot exceed 120 per cent of the maximum retail price of the cheapest medicine competing with the reimbursed product; in case of medicinal products with a price level smaller than the maximum retail price, a 100 per cent reimbursement from their maximum retail price is envisaged, and
• Sub-List C3: certain medicines destined to patients (under 26 years) and pregnant women are reimbursed at a 100 per cent rate for the outpatient The rate applies to the minimum reference price corresponding to the prescribed active substance (international common denomination).

 

Under the Framework Agreement regarding the conditions for medical assistance in the public health insurance system for 2011 to 2012, all expenditures for medication, medical materials and clinical investigations are in theory fully reimbursed by hospitals. In practice, hospitals do not have sufficient funds and even basic health-care products are sometimes lacking.

There is no regulation regarding the reimbursement of medicines under off-label or compassionate use. The compassionate use will likely not be reimbursed, as a prerequisite for the reimbursement would be that the medicine itself is authorised to be put on the mar- ket. Off-label use is not uncommon and there is no court practice regarding the admissibility of reimbursement in such cases. It cannot be excluded that the reimbursement would not be permitted unless the medicine is used within the limits of the ATC 5 prescription.

In 2011, the MoH has started reimbursing the prices of medicinal products supplied for special needs (ie, named patient programmes). The reference price level of such medicines is also currently regulated by the MoH.

is marketed. On the basis of the documentation and calculations  submitted by the manufacturer, the MoH would issue a notification communicating the approved reference price that must be set by the MoH on objective criteria. The reference price is revised by the MoH on a yearly basis or each time the economic and the market condi- tions call for its revision.

Manufacturers could substantially influence the level of the refer- ence price only when the intention would be to lower the price. The lower price level can be applied only for a minimum of one year. Maximum wholesale and retail price levels are further calculated and set by the MoH in accordance with the level of the manufacturer’s maximum price approved (ie, the MoH sets certain capped margins for the entire sales chain).

• If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?

The pricing and reimbursement procedures for medicinal products are addressed by different specialised departments within the MoH and apply only for prescription-only medicines. The authorisation of the reimbursement price for a medicine must be requested by the holder of the marketing authorization or its legal representative in Romania.

According with the rules set out in Order No. 75/2009 regarding the calculation of prices for medicines for human use, the reference price of medicinal products is decided upon request by the General Direction for Strategies and Medicine Policy, within 90 days from the date a complete request had been made by the manufacturer in this respect. As a general rule, a medicinal product’s reference price is decided pursuant to discussions between the MoH and the manu- facturer and must not exceed the lowest price for the same medicine in a list of EU countries where the respective product is marketed.

The inclusion of a medicine in a reimbursement programme is accessible only to medicines included in CANAMED. MoH Order No. 318/2008 together with Annex No. 1b from Order No. 326/2009 rule the procedure for the inclusion of a medicine on a reimburse- ment list. The relevant department for deciding upon the reimburse- ment conditions is the MoH National Transparency Commission.

Once approved, the reference price is valid for one year (starting from the authorisation date). Each year, the reference price must be reapproved. The annual reauthorisation must be formally operated irrespective of whether it is also accompanied by a change of the level of the reference price (at the end of the year, there may be no grounds or need to actually trigger a change of the reference price). In this case, the reference price from the preceding year will be maintained.

Irrespective of the annual update, the reimbursement price may be changed – anytime during the year – according to varying macroe- conomic conditions, a change of the medicines’ prices in the reference countries (ie, the countries with the lowest reimbursement prices), a decrease in the reference price based on a manufacturers’ voluntary decision or whenever a cheaper generic medicine enters the market.

 

• Are manufacturers or distributors of medicinal products statutorily obliged to give a discount?

As mentioned above, prices for prescription-only medicines must be approved by the MoH, which caps manufacturers’, wholesalers’ and retailers’ margins. MoH Order No. 75/2009 on the calculation of prices for prescription-only medicinal products contains specific references with respect to commercial conditions granted to distribu- tors or pharmacies.

Other than that, there is no obligation for manufacturers and distributors to grant discounts or other price reductions. However, this is common practice in Romania, given the reimbursement system that limits the public spending for expensive medicines. A report prepared by the a specialised commission under the president of Romania for the analysis and elaboration of health system politics in Romania (July 2008) argues that discount policies have become business mechanisms vitiating the efficient resource allocation where distributors and pharmacies are granted significant discounts to sell and promote costly medicines to final consumers.

 

Medicine quality and access to information

• put in place a quality management system allowing distributors to immediately inform the marketing authorisation holder about the identification of potentially counterfeit medicines;
• reserve particular storage locations for detected counterfeit products;
• separate the counterfeit products from other medicines during their transportation;
• contribute to the organisation of an effective traceability mecha- nism facilitating the detection of counterfeit products;
• install a written procedure for dealing with claims and infor- mation regarding medicines, including carrying out rapid and efficient withdrawals of the products; and
• safely deal with the recalls of the products from the

 

The NAMMD has created an active rapid alert system with respect to counterfeit products ensuring the dissemination of information to the general public about fake medicines on the market. The Euro- pean Commission ‘Pharmaceutical Package’ also has an impact on the NAMMD’s activity, which intensified its cooperation with other EU member states’ authorities and the European Medicines Agency. Moreover, the NAMMD has made public a new website particu- larly dedicated to the fight against counterfeit products and illegal distribution of medicines (www.crimemedicine.ro). ANMMD has also monitored, in certain cases, the sale of products via the internet, with certain illegal diet or sexual dysfunction medicines being seized in 2009 and 2010.

Another mean of countering counterfeit and illegally distributed medicines is through rules on the protection of intellectual property rights.

• What recent measures have been taken to facilitate the general public’s access to information about prescription-only medicines?

The NAMMD website (www.anm.ro/anmdm/med.html) contains an exhaustive list and details on medicines sold on the Romanian mar- ket. This list – together with the CANAMED classification – contains extensive information on the name of medicinal products, data on active substances, the name of the marketing authorisation holder, the product categories, as well as the regulated reference price. The relevant national legislation does not contain additional rules on the information of the general public on medicines sold under medical prescription. The NAMMD is currently implementing the EU Guide on the clarity of information used on the labelling and prospect for medicinal products (www.anm.ro/html/lizibilitate) at national level. Also, for ensuring more transparency in the overall pharmacovigi- lance compliance mechanism, the NAMMD has set up a national web portal – connected to the corresponding site at EU level – making a wide range of data available to the general public, such as evaluation reports, prospects and risk management plans, as well as actual procedures for the reporting of any suspected adverse reactions or effects by professionals and patients to the NAMMD, with the crea- tion of a standard electronic form for this purpose.

 

26 What rules are in place to counter the counterfeiting and illegal distribution of medicines?

According to article 834 of the Health Care Law, the manufacture and trade of fake medicines is liable to criminal penalties and all parties involved in the distribution chain (ie, suppliers, distributors, retailers) must collaborate to fight against counterfeit medicines merchandised on the Romanian market. The 2006 Good Practices Guide for the Wholesale of Medicines envisages various mechanisms for the prevention or detection of counterfeit medicines sold on the Romanian market.

As a main rule, the manufacturer of medicinal products, its wholesalers and retailers must institute detailed internal rules for the notification of the NAMMD with respect to any counterfeit or defective medicinal products detection on the market. A distributor is particularly required to:

• train its personnel as to avoid the penetration in their distribution chain of fake medicines;
• Outline major developments to the regime relating to safety monitoring of

Title XVII, chapter X of the Health Care Law provides detailed rules on the pharmacovigilance compliance mechanism. The national authority responsible for enforcing a pharmacovigilance system in Romania is the NAMMD.

As a general rule, marketing authorisation holders are responsi- ble for reporting to the NAMMD and recording any cases of adverse effects for medicines. A major instrument in this respect is the Peri- odic Safety Update Reports (PSUR) Worksharing as a means of peri- odic communication with marketing authorisation holders. In line with the European Commission’s regulations, the NAMMD applies guidelines regarding the collection, verification and presentation of reports on adverse effects, technical requirements on the electronic information exchange while communicating the international medi- cal vocabulary used in this respect.

 

 

 

Update and trends

 

 

While extremely controversial negotiations have been carried out between public authorities, industry representatives and stakeholders in 2012, the Romanian health-care system still expects the enactment of a new Health Care Law dealing with problems faced by both public and private healthcare systems. Discussions on new draft legislation are still preliminary and have not yet reached a final step. Its major outcome would be to allow private insurers to enter the public health insurance system that is currently under the monopoly of the MoH and the NHIH. A basic health-care package would still be granted to citizens, while complementary or additional health-care services would need adherence to packages offered by private health insurance houses. The new draft Health Care Law is expected to enter into a legislative debate in December 2012.

Although the long-expected launch of the national health insurance card, the electronic prescription, as well as the digital patient medical system finally took place in 2012, its actual implementation failed to occur, mostly due to technical inconsistencies accompanied by physicians’ reluctance in making use of an even more bureaucratic prescription mechanism.

The Romanian clawback tax saga has reached its third version since 2009. As a first response to the industry protests, the Romanian government enacted an Ordinance annulling several tax debts and penalties for late payments due by manufacturers that have been refusing to pay the clawback tax in September 2012. However, this fiscal facility was not considered to lead to the implementation of an efficient clawback system or to compensate actual expenses  from public resources. The current clawback system forcing manufacturers to bear almost all budgetary expenditures with the reimbursement of medicines covered by the public health-care system is generally considered to not be an effective solution to patients’ problems of access to affordable medicines in Romania, while also visibly discouraging domestic market developments and foreign manufacturers’ market presence. The effect of the clawback system can be seen in the reduction of the market’s overall volumes, while the outpatient reimbursed medicines segment was the weakest in terms of growth in 2012. The latest discussions for the adoption of a new clawback tax system have reached no result.

While the reimbursement lists have not been effectively updated for almost four years, the MoH is planning on finding solutions to supplement the list with approximately 150 medicines to be introduced in 2013, mostly responding to oncology, heart and diabetes patients’ treatment needs. One of the practical means to ensure the feasibility of this measure would be the provision of co-payment obligations for most medical services.

The MoH has also committed to the implementation of several measures for the optimisation of the national health-care system (eg, reorganisation of the public hospital network, the reconsideration of medical services covered by the basic health-care package) in     its strategic paper for August 2011 – May 2012. The MoH has also aimed at encouraging private investor involvement in the local health- care market by supporting independent private projects, as well as public-private partnerships.

Also, starting from next year, the MoH is expected to switch from a heavily decentralised hospital procurement system to a medicines and sanitary materials procurement mechanism exclusively operated by the MoH (a system previously in existence prior to 2007). The main reason for this dramatic reorganisation is related to cost coordination and local corruption risk mitigation. While this system has already obtained government aproval, objections from the antitrust regulator are expected given past experience with this procurement system (see question 12).

 

Specific technical requirements issued by the NAMMD force distributors to include in distribution agreements concluded with manufacturers special provisions on the pharmacovigilance compli- ance procedure. The NAMMD conducts inspections at suppliers’ and distributors’ premises in order to observe compliance with the above technical requirements and to detect any eventual or reported adverse effects. For properly responding to inspection requirements, marketing authorisation holders must ensure continuous assistance from a qualified person responsible with the pharmacovigilance com- pliance system, as well as to operate an effective and up-to-date risk management system. Particular risk management requirements can be imposed by the NAMMD for a specific medicine whenever actual risks potentially influencing the risk-benefit ratio are suspected.

Furthermore, in 2011 the NAMMD enhanced its market surveil- lance mechanism. Wholesale distributors of medicinal products for human use now must report statistical information related to the trading of the medicines from their own portfolios monthly to the NAMMD. The reporting shall specify certain characteristics of the medicinal products such as the quantities, the fabrication series and the names of the suppliers or of the beneficiaries of the medicinal products as well as the identification of the fiscal documents. Whole- salers are also required to facilitate the depicting of the counterfeit pharmaceuticals and to ensure a proper prevention of such drugs entering the distribution channels, as well as the prevention of unlaw- ful parallel distribution channels by means of periodical reporting to the NAMMD (NAMMD Scientific Board Decision No. 5/2011).