Life Sciences
in 24 jurisdictions worldwide
Contributing editor: Alexander Ehlers
2014
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Introduction Alexander Ehlers Ehlers, Ehlers & Partner Argentina Andrea Robles Moeller IP Advisors Austria Rainer Herzig Preslmayr Rechtsanwälte OG Belgium An Vijverman Dewallens & partners Brazil Beatriz M A Camargo Kestener, Marco Aurélio A Torronteguy and Rubens Granja Mattos Muriel Kestener Advogados Canada Timothy Squire and Mathieu Gagné Fasken Martineau DuMoulin LLP Colombia Carlos R Olarte, Andres Rincon and Liliana Galindo OlarteMoure Denmark Poul Heidmann and Nicolaj Kleist Bruun & Hjejle France Christophe Henin and Anne Servoir Intuity Germany Alexander Ehlers Ehlers, Ehlers & Partner Hungary Sándor Németh and Rita Plajos Szecskay Attorneys at Law Japan Junichi Kondo, Yoshikazu Iwase, Kenshi Ando, Saori Ikeda and Yuu Ishikawa Anderson Mo¯ri & Tomotsune Mexico Alejandro Luna F and Juan Luis Serrano Leets Olivares Portugal César Sá Esteves and Ana Menéres SRS Advogados Romania Carmen Peli and Mihaela Ciolan PeliFilip SCA Russia Andrey Zelenin and Sergey Patrakeev Lidings Singapore Benjamin Gaw and Tony Yeo Drew & Napier LLC South Africa Dario Tanziani, Alexis Apostolidis and Pieter Visagie Adams & Adams |
onTEnTS
3 4 10 16
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Sweden Odd Swarting and Camilla Appelgren Setterwalls Advokatbyrå AB
Switzerland Frank Scherrer Wenger & Vieli AG |
116
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Turkey Özge Atılgan Karakulak, Dicle Dog˘an and Tug˘çe Avcısert Geçgil
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129 |
| Life Sciences 2014
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143 151 ue 164 |
Romania
Carmen Peli and Mihaela Ciolan
PeliFilip SCA
Organisation and financing of health care
various national health-care programmes and are theoretically, to a large extent, free of charge.
1.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
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. 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, coor- dination and monitoring functions in most health-care areas. The NHIH is the body with strategic functions regarding the public national health insurance fund. From June 2012, the NHIH is also responsible for the management of the national electronic health- care card system. Both authorities have a pyramidal structure, with decentralised services in each county.
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.
2.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 Romanian citizens and foreign residents in Romania. A significant contribution (as a percentage from the overall revenue) is paid by both the employer and the employee. Every insured person has the theoretical right to receive a quite substantial basic package of medi- cal 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 health- care services and products for the outpatient sector. From April 2013, only a very limited sector of private health-care facilities can theoretically receive repayments for the in-patient sector. 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
and financing of the health-care system.
Compliance – pharmaceutical manufacturers
3.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. 18/2013) abolishing the former NAMMD Scientific Council Guide No. 21/2011. 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 manda- tory for all the information from the advertising material for a spe- cific medicinal product to mirror the information on the Summary 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 mon- itoring 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.
4. 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 infor- mation 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 informa- tion 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 of prescription-only medicinal products aimed at health-care professionals are detailed in the Code for an Ethical Advertising of Medicinal Products issued by the Romanian Association of International Producers of Medicinal Products (ARPIM Ethical Advertising Code – 2012) and in the Ethical Code of Conduct issued by the Romanian Association of Producers of Generic Medicines (APMGR Ethical Advertising Code – 2013). Both codes provide that promotional materials have to be sent or directed only to health-care professionals and disallow the distribu- tion of such materials in places that are accessible to the general pub- lic such as pharmacies, waiting rooms, halls of hospitals and medical clinics. Other rules refer to transparency conditions for advertising campaigns, hospitality and sponsorship for health-care profession- als, the distribution of samples of medicinal products, etc. These codes do not enjoy legal force but provide sanctions for the members of the associations in case of non-compliance with the rules.
5 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 instructions 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 noto- rious 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, etc.
No advertising activity aimed at the general public can be carried
out regarding:
- medicinal products sold only 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.
6.
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.What are the most common infringements committed by manufacturers with regard to the advertising rules?
In NAMMD practice, penalties are applied mostly to the mar- keting 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 manufacturer for broadcasting a TV spot going against the version that had been previously approved; in January 2012 the NAMMD ordered the withdrawal of advertising materials for several medi- cines inappropriately distributed to health-care professionals; while in February 2013 the NAMMD sanctioned a local manufacturer for the distribution of unauthorised advertising materials and the use of unauthorised distribution channels.
Given the relative frequency of infringements of the Advertising Guide, the NAMMD has decided to strictly regulate the size, fea- tures and presentation of advertising materials (eg, shelf talkers, wobblers, stoppers, counter displays, floor stickers, posters, dummy boxes, ceiling hangers, flyers, banners, newsletters, etc) in compli- ance with advertising rules.
7. 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.
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?
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 and the APMGR Ethical Advertising Code set forth the conditions and the limits of spon- sorships offered to health-care professionals, while prohibiting the offering of any personal gifts to any health-care professional. However, the sponsorships offered by the members of the APMGR target the organiser of a medical event rather than individual health-care professionals. As these rules do not enjoy legal force, ARPIM and AMPGR are currently lobbying for the introduction of mandatory rules. Also, in June 2013 the European Federation of Pharmaceutical Industry and Associations (EFPIA) has adopted a Code on disclosure of transfers of value from pharmaceutical com- panies to health-care professionals and health-care organisations. This Code must be implemented by its members (including ARPIM which is an affiliate member) by 31 December 2013.
In the context of a European project on this matter, the MoH intends to regulate in 2014 the collaboration of the pharmaceutical industry with health-care professionals in order to increase transpar- ency and to provide for the latter an obligation to publish the spon- sorships they have beneficiated from the pharmaceutical industry.
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.
9. 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 incentive to prescribe, purchase, provide, sell or administer a Only inexpensive gifts can be offered or given to health-care professionals;
- the sponsorship of an event or a health-care professional par- ticipation at conferences should always be 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 promotional campaign for medicines.
10 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. Also, in order to avoid the influence of a physician’s choice, the Romanian Competition Council has recommended to the MoH, in its report on the distri- bution of medicines in Romania from 2011, the regulation of the meaning of ‘symbolic’ and ‘inexpensive’ gifts which could be offered by the manufacturers to physicians. No such measure has been taken by the authority at this time.
11. 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 suppliers (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;
- 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 event.
12. Are manufacturers’ infringements of competition law pursued by national authorities?
Manufacturers’ infringements of both domestic and EU competi- tion rules are pursued by the Romanian Competition Council. The Council 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 context of public tenders for the acquisition of insulin for the National Diabetes Programme (Competition Council decision No. 15/2008). These fines were finally upheld (for the supplier) and par- tially quashed (for the distributors) by the High Court of Justice in 2013. Significant fines were also applied to dialysis services and product providers. Also, on the basis of recommendations made by the Competition Council, in 2007 the national health authorities switched, in connection to acquisitions for national programmes, from a centralised system to a decentralised (hospital) system.
However, in 2013 the government switched back to a centralised procurement system operated by the MoH for certain medicines and sanitary products (as provided in MoH Order No. 658/2013).
In 2011 and 2012, the Competition Council fined four large sup- pliers 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 regarding the entire pharmaceutical industry (eg, the organisation of public 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 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 statements 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 foreclosure, while potentially restricting competition between distributors attend- ing 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 between manufacturers and health-care professionals, recommending 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).
As a sequel to the sector inquiry finalised in April 2011, in March 2013 the Competition Council opened another sector inquiry focused on the degree of penetration of generics on the Romanian market. The inquiry also aims to identify the possible consequences on the market of changes suppliers make to their dis- tribution systems (for example by reducing the number of distribu- tors or by applying vertical integration models in the distribution of pharmaceuticals).
Another priority for the Competition Council is the sector of medical services, as concerns have been raised that doctors, through their associations, are setting prices for medical services which are not covered by the national public health-care insurance system. Also, a complaint has been submitted to the Competition Council against the MoH, which limited the access of private health-care facilities to payments for the in-patient sector, as mentioned in question 2.
The Council has also been involved in the health-care and phar- maceutical 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 cal- culation methods of the reimbursement price within the national health-care programmes. As a general strategy, the Competition Council confessed not encouraging further reductions of the reim- bursement 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 contributors together with a differentiated approach between innovative medi- cines and generics would likely enhance a better implementation of the clawback tax.
13 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
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 legislation provides no specific rules on the advertising of medical devices or the collaboration of medical devices manufac- turers 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 compared to medicinal products.
General rules on the advertising of products apply; however, these may be insufficient for medical devices that contain a medicine component.
Pharmaceuticals regulation
15. 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).
16. 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.
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.
17. What are the relevant procedures?
- The marketing authorisation procedure before the NAMMD is reserved for those medicines that have not been previously author- ised for marketing purposes at EU level. The duration of the authori- sation 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 authori- sation shall 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 mutual and decentralised 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 analysis 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 pharmacovigilance irregularities or if the respective medicine has been used by an insufficient number of relevant patients.
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 rea- sons motivated by the public interest justify the extension of the mar- keting authorisation. Such exceptions must be rigorously justified.
19. Which medicines may be marketed without authorisation?
The marketing authorisation is not necessary for radiopharmaceutical 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- sively using 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 prescription 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 processed by an authorised supplier for the manufacture of final medicinal products.
20.Are any kinds of named patient 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 MoH Order No. 85/2013. The NAMMD would authorise the supply of medicinal products 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 procedures.
No advertising is allowed in relation to such medicinal products. The NAMMD may consider waiving certain obligations related to the packaging and labelling conditions for medicines supplied in expanded access programmes.
Data on the expanded access programmes currently authorised do not seem to be publicly available. The NAMMD can also tempo- rarily exceptionally authorise the distribution of medicinal products not covered by a marketing authorisation in the case of suspected or confirmed epidemics or the release of chemical or nuclear substances capable of endangering the public health, or in other cases of need not covered by authorised medicines.
Pricing and reimbursement of medicinal products
21 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 prod- ucts are regulated. MoH sets maximum manufacturer prices, maxi- mum wholesale prices and maximum retail (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).
As a general rule, the reference price must not exceed the lowest price for the same medicine in the EU countries where the medicine 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 using objective criteria. The reference price is revised by the MoH on a yearly basis or each time the economic and market condi- tions call for its revision.
The maximum manufacturer prices approved by the MoH may not be increased. They may, however, be revised downwards.
The reference price is not always fully reimbursed by the NHIH. Government Decision No. 720/2008 set out lists of active sub- stances and provides that reimbursement rates apply to the cheapest medicine among those covered by the same active substance (ATC 5 level). This policy obviously favours generic medicines.
22 Must pharmaceutical manufacturers negotiate the prices of their products with the public health-care providers?
The law does not set an obligation for the manufacturers to negoti- ate the prices of their products. In theory, the manufacturers could sell their products at the CANAMED reference price. However, most pharmaceutical products are sold to public health-care provid- ers on the basis of tenders. These tenders are organised either by the MoH, who in November 2012 was designated as the centralised public body for the procurement of certain medicines and sanitary materials, or directly by public health-care providers. In such ten- ders, competing medicines, materials or devices may therefore see their price discounted as a result of the tender. During the tender procedures, the contracting authorities usually invite distributors to supply pharmaceutical products on an active substance basis (inter- national common denomination), although, in the past, tenders based on the commercial denomination of the products were quite frequent.
23 In which circumstances will the national health insurance system reimburse the cost of medicines?
Government Decision No. 720/2008 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 2013 to 2014, all expenditures for medication, medical materials and clinical investigations are in theory fully reimbursed by hospitals. In prac- tice, 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.
24 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.
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 Directorate 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. 724/2013 together with Annex No. 1 and Annex No. 2 from Order No. 398/2013 rule the procedure for the inclusion of a medicine on a reimbursement list. The fulfilment of the reim- bursement conditions is verified by the Evaluation Unit for Medical Technologies, the MoH National Commission and the specialised commissions and directorates within the MoH. Starting from the third trimester of 2013, the reimbursement lists should be updated twice a year and approved by government decision.
Once approved, the reference price is valid for one year (start- ing 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 reference price may be changed – anytime during the year – according to varying macro- economic conditions, a change of the medicines’ prices in the refer- ence countries (ie, the countries with the lowest reference prices), a decrease in the reference price based on a manufacturers’ voluntary decision or whenever a cheaper generic medicine enters the market.
25. 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 ref- erences 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 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.
At the same time, since 2009 the government has been issuing various forms of clawback rules. Although there are a lot of debates and disputes still pending on this matter, the current clawback rules regulated by Government Emergency Ordinance No. 77/2011 have started to be consistently applied. The pharmaceuticals compa- nies are thus bound to contribute to the state budget an additional amount calculated on a sales basis.
Medicine quality and access to information
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 2008 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 distribu- tion chain of fake medicines;
- put in place a quality management system allowing distribu- tors 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 mechanism 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 market.
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 European 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 particularly 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.
In December 2012, the government transposed the provisions of Directive 2011/62/UE of the European Parliament and the Council amending Directive 2001/83/CE, creating a community code to off- set counterfeit medicines in the distribution chain by Government Emergency Ordinance No. 91/2012, and thus several additional measures were regulated. The NAMMD has an obligation to verify that the manufacturing of medicines, the import, manufacturing and distribution of active substances as well as the wholesale distribu- tion of medicines are realised based on a valid authorisation, and to insert the information related to the authorisations in a EU database. Also, in three years the NAMMD has to issue measures implement- ing the labelling of medicines: every medicinal product (except cer- tain radiopharmaceutical products) has to contain safety features that allow the identification of the authenticity of the product and the individual packs, and a device that shows if the packaging has been illegally modified. This request mainly regards prescription- only medicines but can also be applied to OTCs if the NAMMD identifies risks of OTC counterfeiting.
Another method of countering counterfeit and illegally distrib- uted medicines is through rules on the protection of intellectual property rights.
27. 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 market. 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 approved (in 2009) and currently implements the Guide on the clarity of information used on the labelling and prospect for medicinal products (transposing the relevant EU Guide) at national level. Also, for ensuring more transparency in the overall pharmacovigilance compliance mecha- nism, 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 profession- als and patients to the NAMMD, with the creation of a standard electronic form for this purpose.
28. Outline major developments to the regime relating to safety monitoring of medicines.
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 respon- sible for reporting to the NAMMD and recording any cases of adverse effects for medicines. A major instrument in this respect is the Periodic Safety Update Reports (PSUR) Worksharing as a means of periodic communication with marketing authorisation holders. In line with the European Commission’s regulations, the NAMMD applies guidelines regarding the collection, verification and presenta- tion of reports on adverse effects, technical requirements on the elec- tronic information exchange while communicating the international medical vocabulary used in this respect.
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 compliance 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 when- ever actual risks potentially influencing the risk-benefit ratio are suspected.
Furthermore, in 2011 the NAMMD enhanced its market sur- veillance 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 medici- nal products as well as the identification of the fiscal documents. Wholesalers are also required to facilitate the depicting of the coun- terfeit pharmaceuticals and to ensure a proper prevention of such drugs entering the distribution channels, as well as the prevention of unlawful parallel distribution channels by means of periodical reporting to the NAMMD (NAMMD Scientific Board Decision No. 9/2012).
Vaccination
29. Outline your jurisdiction’s vaccination regime for humans.
The vaccination regime for humans was set by Government Decision No. 53/2000 regarding the obligation to report diseases and to per- form vaccinations, which recommends the vaccination of children between 0 and 14 years on the basis of a vaccination scheme. Such scheme is part of the National Immunisation Programme approved by the MoH. The vaccinations included in the scheme are free of charge and, based on their type, can be performed by doctors in birth centres, family doctors or doctors working in schools. There is a Unique Vaccination Register which has to be completed by the doctors administering vaccinations, and also a Vaccination Book created once a child is born and filled with the administrated vaccinations.
However, there are several legal provisions which seem to create a mandatory regime for vaccinations. In this respect, the schools can- not sign up students without their Vaccination Book. Although this condition was initially introduced in 1995, it raised concerns regard- ing the obligation to vaccinate in 2011 when Government Decision No. 857/2011 was issued. This Decision established pecuniary sanctions for schools signing up children without the proof of man- datory immunisation provided by the Vaccination Book. Currently there is a controversial debate on the mandatory regime of vacci- nations, with two different opinions being expressed. One opinion says that, although the law does not expressly provide the obligation to vaccinate, every person on Romanian territory should submit to every measure of prevention and fight against contagious diseases, vaccination being such a measure. In another opinion, the patients have the right to give their consent for, or refuse, every medical inter- vention, except for exceptional situations, and should be able to refuse vaccination. Up to this moment there is no clear position on this matter and we are not aware of contestations before the court on the obligation to vaccinate. Also, more and more parents started to refuse to vaccinate their children.
The national authorities have the obligation to transmit an annual report to the WHO on vaccinations and contagious diseases. According to the monitoring system of the WHO, in general, in Romania more than 90 per cent of the target population is vacci- nated every year.
Besides vaccinations for the youngest age group, the National Immunisation Programme also contains selective vaccinations, which are free of charge, for those who are exposed to additional risk factors. Also, patients have at their disposal other vaccinations for which they must pay.
Furthermore, the MoH can decide on the implementation of additional, free of charge vaccination campaigns as a measure of public health-care or in case of epidemiological situations with increased risk of disease.
Update and trends
Although controversial negotiations have continued between public authorities, industry representatives and stakeholders in 2013, the Romanian health-care system still expects the enactment of a new Health Care Law dealing with problems faced by both public and private health-care systems (including the severe underfinancing of the public system). A public consultation on the new draft legislation has been opened in October 2013, and there is no clear timeline for its entering into force. A major interest represents the basic health- care package which, according to new proposals, should be granted to both insured and non-insured patients within the public system. At the same time, the proposals also provide that the non-insured will be
granted only prevention medical services, emergency medical services and national health-care programmes. At this stage it is unclear which policy will prevail. The new package seeks to limit the services to be provided in the in-patient sector. Once the health-care basic package is adopted, the MoH intends to discuss an additional package for private medical services.
The MoH has also committed to update the reimbursement lists for medicines which have not been modified for almost five years.
In April 2013, the MoH decided to suspend the parallel exports for 28 oncologic monitored medicines which are considered to present important risks of shortage. Although this was a temporary solution,the MoH committed to implement a strategy aiming to avoid shortages of medicines in Romania and to discourage parallel exports. The MoH also intends to modify the rules on the reporting activity of the wholesale distributors, importers and manufacturers in order for the latter to indicate the country of destination for the medicinal products exiting the country.
The Romanian clawback tax saga continued in 2013, when the Constitutional Court found that Emergency Government Ordinance No. 77/2011 was partially unconstitutional as the VAT was included in the base used for the calculation of the tax, and thus the medicines were given a double taxation. Following this decision, there were several successful court actions demanding the recovery of important amounts calculated with the VAT included. The industry representatives continue to criticise the claw-back tax, as it is calculated by reference to the shelf price and thus the manufacturers have to also pay for distributors and pharmacies. Also, the MoH has issued the view that a different formula for the claw-back tax should be used for original and generic medicines.
In 2014, the MoH is expected to implement several measures for the organisation of the national health-care system, such as the reorganisation of the public hospital network, the re-allocation of responsibilities between the MoH, the NHIH and the NAMMD, the medical services covered by the basic health-care package and the clarification of the role of private components in the health system. As the electronic prescription became mandatory from January 2013, and all eligible patients are supposed to receive their electronic patient card by the end of 2014, a successful implementation of the electronic health-care system is expected.
Finally, in September 2013, the MoH released for public consultation a draft law transposing Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights in cross-border health care. This aims to regulate the payment of health-care services provided to patients included in the national public health insurance system, by health-care facilities located in the European Union. The directive was to be transposed by the member states by 25 October 2013, but Romania has not yet adopted the transposing law.
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LIFE SCIENCES 2014 ISSN 2042-4329
