Cross-border Life Sciences Handbook 2011 – Romania: Q&A
Published in “Practical Law Company (PLC) Cross-border Life Sciences Handbook”, 2011
Regulatory overview
1. Please give a brief overview of the regulatory framework for medicinal products/pharmaceutical products/drugs (as they are called in your jurisdiction), including the key legislation and regulatory authorities. If biotechnology products are treated differently, please specify the differences.
Romanian Ministry of Health (“Ministry”) and the National Agency for Medicinal Products and Medical Devices (“ANMDM”) are responsible for protecting the public health in Romania, by assuring the safety and efficacy of (among others) medicinal products for human use.
No medicinal product may be placed on the market in Romania unless a marketing authorisation has been issued by ANMDM or by the European Medicines Agency (“EMEA”).
Pricing and state funding
2. Please give a brief overview of the structure and funding of the national healthcare system.
In Romania, social health insurance is mandatory, and has as objectives (a) protecting ensured persons towards the costs of medical services in case of decease or accident and (b) ensuring universal, equitable and non-discriminatory protection of ensured persons.
While voluntary heath insurance is also allowed, it does not exclude the obligation to pay for the social health insurance.
3. In what circumstances are the prices of medicinal products regulated?
According to Order 75/2009 for the approval of Norms regarding the mode of calculation of prices for medicinal products for human use, as further amended, the price for OTC products is set freely by the marketing authorisation holder and notified to the ministry, while for Rx products, the price is proposed by the marketing authorisation holder or its representative, and approved by the Ministry, by comparison with the prices for the similar products in 12 European countries, or, should the product not be commercialised in any of the said 12 countries, with the price in the country of origin. The new legislation also introduced the policy of price comparison between original, first generic and generic products upon approval.
Prices in the reimbursement system are also strictly regulated.
4. When is the cost of a medicinal product funded or reimbursed by the state? Please briefly outline the procedure and pricing for state funding or reimbursement (for example, is the reimbursement paid to the producer, pharmacist or end-user)?
Health insurance houses conclude agreements with providers of medicinal products, having in view the interest of ensured persons and the quality and efficiency of the services provided, based on criteria established by the Ministry.
While the law expressly provides the possibility that the health insurance houses conclude the agreements with pharmacies, distributors or producers, in most cases, in practice, the reimbursement is paid to pharmacies.
Lack of funds and huge delays in payment of the amounts due to pharmacies permanently place the health insurance system in Romania on the edge.
Manufacturing
5. Please give an overview of the authorisation process to manufacture medicinal products. In particular:
• To which authority must the application be made?
• What conditions must be met to obtain authorisation?
• Are there specific restrictions on foreign applicants?
• What are the key stages and timing?
• What fee must be paid?
• How long does authorisation last and what is the renewal procedure?
Application
According to Law 95/2006 regarding reform in the healthcare field, as further modified and completed (“Law 95/2006”), the application for manufacturing authorisation is filed with ANMDM, which issues the authorisation only after having made sure of the accuracy of the particulars supplied pursuant to applicable legal provisions, by means of an inquiry carried out by its agents.
Conditions
In order to obtain the manufacturing authorisation, the applicant must meet at least the following requirements:
• specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;
• have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements as regards to both manufacture and control and the storage of medicinal products;
• have at his disposal the services of at least one qualified person.
The applicant must also provide particulars in support of the above in his application.
Restrictions on foreign applicants
While the legislation currently in force provides no express restriction for foreign companies to apply for and be granted manufacturing authorisations in Romania, in practice, we are not aware of ANMDM having granted such authorisation to foreign applicants so far.
Key stages and timing
Within 10 days from the registration of the application for manufacturing authorisation, ANMDM responds to the applicant. In case the application fulfils the legal requirements, the applicant is informed about the approval of its request for inspection, as well as about the fee for inspection. In case the application is incomplete, the applicant is informed about the additional information that needs to be submitted.
The inspection takes place within 10 days from the payment by the applicant of the relevant fee.
Within 20 days from the inspection, ANMDM transmits to the applicant the preliminary / final inspection report. In case of a preliminary report, the applicant must transmit to the authority, within 15 days, the corrective measures plan.
In case of a favourable final inspection report, the authorisation is issued within 90 days from the registration by the applicant of the full documentation.
Fee
The quantum of the fee for the inspection carried out by ANMDM with the view to issue the manufacturing authorisation varies depending on the type of product for which the authorisation is requested. For sterile products, the fee is of EUR 1,496 (fixed fee) + EUR 246 (for each manufacturing flux), while for non-sterile products the fee is of EUR 1,358 (fixed fee) + EUR 203 (for each manufacturing flux).
Period of authorisation and renewals
Manufacturing authorisation is issued for a 3 year term and may be renewed indefinitely for subsequent 3 year periods.
6. What powers does the regulator have to:
• Monitor compliance with manufacturing authorisations?
• Impose penalties for a breach of a manufacturing authorisation?
Law 95/2006 provides the right (and the obligation) of ANMDM to ensure, by means of repeated inspections, and if necessary unannounced inspections, and, where appropriate, by asking own laboratories or laboratory authorized by ANMDM to carry out tests on samples, that the legal requirements governing medicinal products are complied with.
The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials, or at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice.
ANMDM suspends or revokes the marketing authorisation for a category of preparations or all preparations where any one of the requirements for the issuance of the manufacturing authorisation is no longer met. Also, ANMDM may impose fines for breach of legal provisions regarding manufacturing authorisations.
Clinical trials
7. Please give an overview of the regulation of clinical trials. In particular:
• Which legislation and regulatory authorities regulate clinical trials?
• What authorisations are required and how is authorisation obtained?
• What consent is required from trial subjects and how must it be obtained?
• What other conditions must be met before the trial can start (for example, the requirement for a sponsor and insurance cover)?
• What are the procedural requirements for the conduct of the trial (for example, using certain medical practices and reporting requirements)?
Clinical trials are mainly regulated by:
• Law 95/2006;
• Order 903/2006 issued by the Ministry for the approval of the Principles and detailed guides regarding the good clinical trial practice for medicinal products for human use for clinical investigation, as well as the requirements for the manufacturing and the import of such medicines;
• Order 904/2006 issued by the Ministry for the approval of the Norms regarding the implementation of the good practice regulations concerning the conduct of clinical trials performed with medicinal products for human use;
• Order 906/2006 issued by the Ministry for the approval of the norms and analytical, pharmaceutical toxicological and clinical protocols for the testing of medicinal products;
• Order 912/2006 regarding the approval of the Regulations for the authorisation of the units that may perform clinical studies within the medicinal products for human use field.
The competent authorities in the clinical studies field are ANMDM and the Ministry. A significant role is played by the Ethics Committee.
The main authorisations required for carrying out a clinical study are: (i) authorisation for the approval of the units that may perform clinical studies in the field of medicinal products for human use (issued by the Ministry), (ii) the authorisation for carrying out a clinical study (issued by ANMDM); the non-intervention / post-authorisation studies have to be only notified with ANMDM, (iii) authorisation for the fabrication, import/export of the medicinal products used for clinical investigation (issued by ANMDM).
A clinical trial may be undertaken only if, among others, the trial subject or, when the person is not capable of giving his consent [e.g.. minors], his legal representative has given his written consent [in case of incapable persons, e.g. patients submitted to a psychiatric treatment, patients that suffer of dementia, etc., the written consent of the patient’s physician is necessary in addition of their legal representative] after being informed of the nature, significance, implications and risks of the clinical trial and measures have been taken for insurance or indemnity to cover the liability of the investigator and sponsor.
Moreover, in accordance with the Guide for Good Clinical Practice, any review of the form of the written informed consent and of the written information has to obtain the approval/favourable opinion of the Ethics Committee before being used. The trial subject or his legal accepted representative must be prior notified with respect to information which might influence the will of the trail subject to continue its participation in the study. The communication of this information has to be recorded within a document.
The investigator has to conduct the clinical study in accordance with the protocol approved by the sponsor and the competent authorities and for which a favourable opinion / approval from the Ethics Committee has been obtained.
Marketing
8. Please give an overview of the authorisation process to market medicinal products. In particular:
• To which authority must the application be made?
• What conditions must be met to obtain authorisation?
• What are the key stages and timing?
• What fee must be paid?
• How long does authorisation last and what is the renewal procedure?
Application
National marketing authorisations are issued by ANMDM based on the request filed by the applicant.
Conditions
The applicant for a marketing authorisation must be located in Romania or in another state member to the European Union.
ANMDM issues the marketing authorisation after it is satisfied that the medicinal product meets the legal requirements, mainly with respect to:
• Safety;
• Effectiveness;
• Manufacturing;
• Control;
• Labelling;
• Bioequivalence (if the case).
Key stages and timing
The application filed by the applicant is reviewed by the Assessment-Authorisation Department within ANMDM in order to assess that the documentation is compliant with applicable legal provision, and if all requirements for issuance of the marketing authorisation are fulfilled. Following such review, a final report is issued. The report may recommend granting or refusal of the authorisation.
The report is presented in front of the Authorisation Commission, which decides with respect to the issuance of the authorisation.
In case the Authorisation Commission issues a favourable opinion, and subject to the Economic Department confirming payment of all relevant fees, the marketing authorisation is drafted.
In case the Authorisation Commission issues an unfavourable opinion, the applicant is informed, in writing, about the refusal of the application. The refusal may be challenged by the applicant in accordance with the law.
The procedure for granting a marketing authorisation for medicinal products must be completed within a maximum of 210 days after the submission of a valid application. However, in practice the legal deadline is never observed by the authority.
Fee
Fees collected by ANMDM in relation to issuance of marketing authorisation are regulated by Order 716/2009 issued by the Ministry for the approval of fees and value of contribution for maintenance of the marketing authorisation practiced by ANMDM, and vary from EUR 1,920 (for traditional herbal plants and homeopathic medicinal products) to EUR 9,500 (for a full dossier authorisation). For full list of fees, please see http://www.anm.ro/html/ordine_ministru.html.
Period of authorisation and renewals
A marketing authorisation is valid for five years and may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
9. Please briefly outline the abridged procedure for obtaining marketing authorisations for medicinal products. In particular:
• Which medicinal products can benefit from the abridged procedure (for example, generics)?
• What conditions must be met?
• What procedure applies and what information can the applicant rely on?
Applications for which no toxicological, pharmacological or clinical trials are required
The applicant shall not be required to provide results of own toxicological, pharmacological or clinical trials, if he can prove that:
• The product is a generic medicinal products, in case the data exclusivity period for the reference medicinal product has expired;
• The active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions provided by the legislation. In that event, the test and trial results must be replaced by appropriate scientific literature;
• The authorisation holder has allowed the producer to use the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications.
Applications for which the results of pre-clinical tests and clinical trials corresponding to the statute of classification of the medicinal product are required
• The medicinal product does not fall within the definition of a generic medicinal product;
• Biological medicinal product which is similar to a reference biological product, but does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product;
• Medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes;
• Traditional herbal medicinal products;
• Homeopathic medicinal products.
10. Are foreign marketing authorisations recognised in your jurisdiction? If so, please briefly outline the recognition procedure.
Mutual recognition procedure and decentralised procedure
With a view to the granting of a marketing authorisation for a medicinal product in Romania and one or more other states member to the European Union, an applicant shall submit an application based on an identical dossier all relevant member states. The dossier shall contain the information and documents referred to by the applicable legislation, as well as a list of member states concerned by the application.
The applicant shall request one member state to act as “reference member state” and to prepare an assessment report on the medicinal product.
Where the medicinal product has already received a marketing authorisation at the time of application, Romania shall recognise the marketing authorisation granted by the reference member state. To this end, the marketing authorisation holder shall request the reference member state either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be sent to the concerned member states and to the applicant.
In cases where the medicinal product has not received a marketing authorisation at the time of application, the applicant shall request the reference member state to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. The reference member state shall prepare these draft documents and shall send them to the concerned member states and to the applicant.
Member states concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the reference member state accordingly.
Each member state in which an application has been submitted shall adopt a decision.
NOTE: products authorised under centralised procedure by EMEA in accordance with the provisions of laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency may also be placed on the Romanian market.
11. What powers does the regulator have to:
• Monitor compliance with marketing authorisations?
• Impose penalties for a breach of a marketing authorisation?
For the powers of ANMDM to monitor compliance with marketing authorisation, please refer to Section 6 above.
ANMDM suspends or revokes the marketing authorisation if the data provided in supporting the application for marketing authorisation are incorrect or have not been modified in accordance with the law, or the required controls have not been carried out. Also, ANMDM may impose fines for breach of legal provisions regarding marketing authorisations.
12. Are parallel imports of medicinal products into your jurisdiction allowed? If so, please briefly outline what conditions must be met by the parallel importer. Can intellectual property rights be used to oppose parallel imports?
Romanian legislation allows parallel imports of medicinal products, provided that:
• The imported medicinal product has been authorized for marketing in Romania by ANMDM;
• The imported medicinal product to have been exported from a European Union / European Economic Area state;
• The imported medicinal product has been authorized for marketing in the exportation state;
• The imported medicinal product to be sufficiently similar to the original medicinal product, even if differences exist with respect to excipients;
• The applicant presents data and arguments that make plausible the fact that efficacy and safety of the original medicinal product are applicable to the importat medicinal product.
Intellectual property rights may be used to oppose parallel imports into Romania, unless the respective rights have been exhausted (i.e, the product was put on the market in the European Union for the first time by the right holder or with his consent.)
13. Please briefly outline the restrictions on marketing practices such as gifts or “incentive schemes” for healthcare establishments or individual medical practitioners.
No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply medicinal products, unless they are inexpensive and relevant to the practice of medicine or pharmacy
14. Please briefly outline the restrictions on marketing medicinal products on the internet, by e-mail and by mail order.
While Romanian legislation does not expressly forbid marketing of medicinal products through internet, by e-mail or by mail order, de facto, in Romania, medicinal products may only be lawfully sold through physical pharmacies, as only them may be authorized for performing this type of activity.
Advertising
15. Please briefly outline the restrictions on advertising medicinal products. In particular:
• Which legislation applies and which regulatory authority enforces it?
• What types of medicinal product cannot be advertised?
• What restrictions apply to advertising that is allowed?
• If advertising over the internet is treated differently, please identify the differences.
Main applicable legislation
• Law 95/2006;
• Decision 20/2010 issued by the Scientific Council of ANMDM for the approval of the Guide for evaluating advertising for medicinal products for human use;
• Decision 31/2010 issued by the Scientific Council of ANMDM for the approval of certain Regulations regarding advertising for medicinal products for human use.
Also, codes of practice issued by private associations (e.g., Romanian Association of the International Manufacturers of Medicinal Products) regulate the activity of their members:
Medicinal products that cannot be advertised:
• Medicinal products in respect of which a marketing authorisation has not been granted in accordance with the law.
Medicinal products that cannot be advertised to general public:
• medicinal products which (a) are available on medical prescription only, or (b) contain substances defined as psychotropic or narcotic;
• medicinal products which, by virtue of their composition and purpose, are not intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary;
• medicinal products included in the health insurance system.
Survey of advertising:
Advertising for medicinal products is monitored by ANMDM. For OTC products the advertising materials for general public have to be previously approved by ANMDM. Advertising materials for persons qualified to prescribe or supply medicinal products are analyzed by the ANMDM after dissemination, by random survey or as a result of a notification.
Advertising over the Internet:
In case of advertising for persons qualified to prescribe of supply medicinal products, marketing authorisation holder must prove that the access to such information is allowed only to healthcare professionals, within a valid and verifiable password system.
Advertising to general public must observe specific rules imposed by ANMDM with respect to content of the respective web pages.
While advertising of medicinal products through e-mail or SMS is not forbidden, ANMDM recommends that such is not used.
Packaging and labelling
16. Please briefly outline the regulation of packaging and labelling of medicinal products. In particular:
• Which legislation applies and which regulatory authority enforces it?
• What information must the packaging and/or labelling contain?
• What other conditions must be met (for example, information being stated in the language of your jurisdiction)?
Applicable legislation
Packaging and labelling of medicinal products of human use is regulated by Law 95/2006.
Information to be included on the label
As a general rule, the following particulars must appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
• the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults;
• a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
• the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
• a list of those excipients known to have a recognized action or effect;
• the method of administration and, if necessary, the route of administration;
• a special warning that the medicinal product must be stored out of the reach and sight of children;
• a special warning, if this is necessary for the medicinal product;
• the expiry date in clear terms;
• special storage precautions, if any;
• specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate;
• the name and address of the marketing authorisation holder and, where applicable, the name of the representative;
• the number of the authorisation for placing the medicinal product on the market;
• the manufacturer’s batch number;
• in the case of non-prescription medicinal products, instructions for use.
Legislation also provides specific requirements for the package leaflet (which, as a general rule, must be drawn up in accordance with the summary of the product characteristics).
General labelling requirements
The particulars on the label of medicinal products must be easily legible, clearly comprehensible and indelible.
The name of the medicinal product must also be expressed in Braille format.
The particulars for labelling must appear in the Romanian language. This does not prevent these particulars from being indicated in several languages.
Exceptions from the above rules regarding labelling may be granted on a case by case basis by the competent authority for orphan medicinal products or when the product is not intended to be delivered directly to the patient.
Traditional herbal medicines
17. Please briefly outline the regulation of the manufacture and marketing of traditional herbal medicinal products in your jurisdiction.
Romanian legislation provides a simplified registration procedure for traditional herbal medicinal products. In case of such products, no results of pre-clinical tests and clinical trials must be provided.
Also, the summary of the product characteristics is not required to contain clinical particulars.
However, the applicant must provide bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community, as well as a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon additional request, data necessary for assessing the safety of the medicinal product.
Traditional-use registration shall be refused if the application does not comply with the legal provisions or if at least one of the following conditions is fulfilled:
• the qualitative and/or quantitative composition is not as declared;
• the indications do not comply with the conditions provided by the law;
• the product could be harmful under normal conditions of use;
• the data on traditional use are insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of longstanding use and experience;
• the pharmaceutical quality is not satisfactorily demonstrated.
In addition to general labelling requirements, any labelling and user package leaflet for traditional herbal medicinal products shall contain a statement to the effect that (a) the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and (b) the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.
Patents
18. What types of medicinal products and related substances and processes can be protected by patents and what types cannot be patent protected? If process patents only are available for these products and substances, please give details including whether the situation is likely to change. What are the legal criteria to obtain a patent? Which legislation applies?
According to Romanian legislation, (Patent Law 64/1991, as republished, and Implementing Regulation approved by Government Decision 547/2008) a patent may be granted for any inventions having as a subject matter a product or process in all fields of technology, provided that the requirements of patentability are met: the invention is new, involves an inventive step and is susceptible of industrial application. The novelty and the inventive step are assessed based on the state of the art at the date of filing the patent application, which is to be interpreted as meaning the date of priority in appropriate cases.
Both pharmaceutical products and processes for obtaining such products are patentable subject matters according to Patent Law.
19. How is a patent obtained? In particular:
• To which authority must the application be made?
• What fee must be paid?
• What are the key stages and timing?
• Does the patent office operate a deposit system or are applications subject to some form of scrutiny before acceptance?
The authority
A patent application must be filed with the Romanian State Office for the Inventions and Trademarks (“SOIT”).
Fee
For the full schedule of fees for patents, see the following website address: http://www.osim.ro/index3_files/laws/ord41eng.pdf, Annex 1.
Process and timing
The main stages that a patent application follows before a patent is granted are: filing the application, publication of the application, substantive examination and publication of the mention to grant of a patent.
A Romanian patent may be granted within a time-limit of 18 months from the filing date but this happens in very few cases. For the large majority of patent applications the substantive examination may last between three and five years.
If the Examining Division of SOIT refuses the patent application, the applicant may challenge the decision before the Reexamining Division, and further before the courts.
20. How long does patent protection last? How is a patent renewed or patent protection extended? If the patent itself cannot be extended, can the organisation’s monopoly rights be extended by other means, such as supplementary protection certificates or (regulatory) data exclusivity periods?
The patent protection lasts for 20 years from the date of filing of the application. Annuity fees are due for each year of protection.
Supplementary protection certificates may also be granted. Such takes effect at the end of the lawful term for the basic patent, not exceeding five years. Furthermore, the duration of a certificate may be extended by six months for pediatric use of the respective product.
Also, data exclusivity is regulated by Law 95/2006, similar to the European legislation.
21. In what circumstances can a patent be revoked?
A patent may be revoked in an opposition proceeding before the Re-examining Division of SOIT. Any person may request revocation of the patent within six moths from the publication of the mention to grant of the patent in case the subject matter of the patent (i) is not patentable, (ii) does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, or (iii) extends beyond the content of the application as filed.
A patent may also be revoked following an annulment action on merits filed with the Romanian Courts. The grounds for annulment are similar with those specified before, but two additional grounds are provided: (i) protection conferred by the patent was extended or (ii) the patent owner is not the person entitled to the grant of the patent.
22. When is a patent infringed? How is a claim for patent infringement made and what remedies are available?
A patent is infringed when the following acts are performed without the consent of the patent owner:
• manufacturing, using, offering for sale, selling or importing for the purpose of using, offering for sale or selling, where the subject matter of the patent is a product;
• using the process and using, offering for sale, selling or importing for those purposes the product directly obtained by the patented process, where the subject matter of the patent is a process.
The patent owner may file action in infringement before the Romanian courts. In the case of patent infringement litigation the burden of proof rests with the plaintiff.
The owner may also apply for a preliminary injunction.
In addition to the obligation of the defendant to cease the infringement, the plaintiff may be awarded damages for the prejudiced suffered.
Trademarks
23. Can a medicinal product brand be registered as a trade mark? What are the legal criteria to obtain a trade mark? Which legislation applies?
Romanian legislation governing trademarks, i.e., Law 84/1998 on trademarks and geographical indications, as republished and its Implementing Regulation approved by Government Decision 1134/2010 does not provide for a special legal regime for medicinal product brands. Therefore, such may be registered as trademarks by filing trademark applications with SOIT, with the observance of the general legal requirements, mainly the absence of absolute or relative grounds for refusal.
24. How is a trade mark registered? In particular:
• To which authority must the application be made?
• What fee is payable?
• What are the key stages and timing?
The authority
The trademark application must be filed with SOIT.
Fee
The amount of the official fees implied by the registration of a national trademark varies, depending on the number of classes of goods and/or services for which protection is sought, as well as whether it is a verbal or combined trademark and whether it is filed in color or in black and white. For the full schedule of fees for trademarks, please see http://www.osim.ro/index3_files/laws/ord41eng.pdf.
Process and timing
The trademark application is electronically published within maximum seven days as of its filing with SOIT. Within two months as of this publication, any interested person may file opposition/observations against the registration of the trademark, based on relative/absolute grounds for refusal.
As a result of the examination and within maximum six months (three months in the expedited procedure, on condition of payment of a supplementary emergency fee) as of the electronic publication of the trademark application, SOIT issues a decision of acceptance or refusal at registration of the trademark application.
In case of acceptance, the trademark is registered in the Trademarks Register and is electronically published within maximum two months as of the issuance of the registration decision, and SOIT issues the trademark registration certificate.
SOIT’s decision of acceptance or refusal at registration of a trademark may be challenged by any interested party within 30 days of its communication or publication, and further appealed before the Bucharest Tribunal.
Therefore, as a rule, the registration process takes up to nine months and seven days (six months and seven days in the expedited procedure), if no oppositions or contestations are filed.
25. How long does trade mark protection last? How is a trade mark renewed?
The initial duration of protection of a trade mark is of ten years as of the filing date, and may be indefinitely renewed for subsequent ten years terms. A trademark is renewed by filing a renewal application with SOIT prior to the expiry of the protection period (but no sooner than three months prior to such expiry), with the payment of the renewal fees.
26. In what circumstances can a trade mark be revoked?
Any interested person may request Bucharest Tribunal, during the entire protection period of a trademark, to deprive the trademark owner of his rights if:
• without legitimate reason, the trademark was not effectively used in Romania within an uninterrupted period of five years as of the registration of or if its use has been suspended for an uninterrupted period of five years;
• the trademark became the usual name for the goods/services for which it is registered, as a result of the trademark owner’s actions or inactivity; or
• the trademark was registered in the name of a person other than the trademark applicant or owner.
Also, any interested party may file a legal action with Bucharest Tribunal seeking cancellation of a trademark registration on any of the following grounds:
• there were absolute or relative grounds for refusal at the time of registration;
• the registration was applied for in bad faith;
• the registration infringes the image rights or name of a person, or earlier intellectual property rights.
Such action may be filed within a five years term as of the trademark registration, except where the registration was applied for in bad faith, in which case an action may be brought during the entire protection period of the trademark.
27. When is a registered trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?
A trademark is infringed when an unauthorized third party uses in its commercial activity a sign:
• identical with the trademark for identical goods/services;
• identical/similar to the trademark for identical/similar goods or services, provided that such use is likely to create a risk of confusion on the part of the public, including the risk of association with the trademark;
• identical/similar to the trademark having a reputation in Romania, for different goods/services, provided that an undeserved advantage deriving from the distinctive character or from the reputation of the trademark could be obtained or if such use could prejudice the trademark owner.
The trademark owner may file criminal complaints against infringers or civil actions in infringement, with the possibility to claim the cease of the unlawful acts and also damages for the prejudice suffered.
The trademark owner may also request preliminary injunction.
28. Is there a requirement for a patent or trade mark licence agreement to be approved by any government or regulatory body? If so, please provide details including anticipated timelines and cost.
In order for the patent or trademark license agreements to be opposable against third parties, such must be registered with SOIT and published in the Official Bulletin of Industrial Property (OBIP).
Bucharest Tribunal may grant compulsory licenses for patents in certain specific cases.
29. Is there a requirement for remittance of royalties payable under a patent or trade mark licence agreement to a foreign licensor to be approved by any government or regulatory body? If so, please provide details including anticipated timelines and cost.
No.
30. Is your jurisdiction party to international conventions on patent and trade mark protection?
Yes, such as:
• Paris Convention for the Protection of Industrial Property;
• Patent Cooperation Treaty;
• Agreement on Trade-Related Aspects of Intellectual Property Rights;
• European Patent Convention;
• World Intellectual Property Organization Convention;
• Madrid Agreement on the International Registration of Marks;
• Madrid Protocol;
• Nice Agreement on the International Classification of Goods and Services;
• Vienna Agreement Establishing an International Classification of the Figurative Elements of Marks.
Product liability
31. Please give an overview of medicinal product liability law, in particular:
• Under what laws can liability arise (for example, contract, tort or statute)?
• What is the substantive test for liability?
• Who is potentially liable for a defective product?
Legal provisions
• Law 95/2006;
• Law no. 245/2004 on general product safety, as republished;
• Law no. 240/2004 on the liability of manufacturers for the damages caused by defective products;
• Government Ordinance no. 21/1992 regarding consumers’ protection, as republished;
• Romanian Civil Code.
Substantive test
The injured person has to prove the damage, the defect and the causal relationship between defect and damage in order to entail the civil liability of the producer.
Liability
The producer is liable for the actual and future damage caused by a defect in his product. Producer is defined as: (i) the manufacturer of a finished product, the producer of any raw material or the manufacturer of a component part, (ii) any person who, by putting his name, trade mark or other distinguishing feature on the product presents himself as its producer, (iii) any other person who imports in Romania a product for sale, leasing, purchasing or any form of transfer in the course of his business shall be deemed to be a producer and shall be responsible as a producer in the same measure as the producer, (iv) any other persons, who imports into the European Union a product for sale, leasing, purchasing or any form of transfer in the course of his business shall be deemed to be a producer and shall be responsible as a producer in the same measure as the producer. Where the producer of the product cannot be identified, each supplier of the product shall be treated as its producer unless he informs the injured consumer, within a reasonable time, of the identity of the producer or of the person who supplied him with the product. The same shall apply, in the case of an imported product, if this product does not indicate the identity of the importer as mentioned herein above even if the name of the producer is indicated.
In addition, the claimant may also sue his physician for malpractice.
32. What are the limitation periods for bringing product liability claims?
The right to file a legal action for the recovery of the damage has a statute of limitation of three years as of the date the plaintiff knew or should have known the prejudice, the defect and the producer’s identity, while the action for the recovery of the prejudice caused by a defective product can not be introduced more than 10 years as of the date the producer put the product on the market.
33. What defences are available to product liability claims?
The producer is not liable if he proves that:
• he did not put the product into circulation; or
• having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation by him or that this defect came into being afterwards from causes that can not be imputed to him; or
• the product was neither manufactured for sale or any form of distribution for economic purpose of the producer and has not been manufactured or distributed by him in the course of his business; or
• the defect is due to compliance of the product with mandatory regulations issued by the public authorities; or
• the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered; or
• the defect is due to non-observance by the consumer of the use instructions that accompany the product.
The manufacturer of a component is not held liable if he proves that the defect is attributable to the instructions given by the manufacturer of the product.
34. What remedies are available to the claimant?
Civil claims for the recovery of the damage, contractual or extra contractual civil actions. Also, criminal complaints may be filed with the competent authorities.
Please note that, according to Law 95/2006, placing on the market of counterfeited medicinal products or any medicinal product breaching the legal provisions, that migh be harmful for human health, represents criminal offence, sanctioned with imprisonment for natural persons and criminal fine for legal persons. Complementary sanctions may also be applied.
35. Are class actions allowed for product liability claims? If so, are they common?
The consumers’ associations are allowed to file legal action before the competent courts in order to defend the rights and interests of the consumers. Based on publicly available information, such actions are not common in Romania.
36. Are punitive damages allowed for product liability claims? If so, are they common? What comment can you make about likely quantum?
Yes, punitive damages are allowed for product liability claims. The award of punitive damages as well as their value depends on a case by case basis.
Reform
37. Please summarise any proposals for reform and state whether they are likely to come into force and, if so, when.
2010 brought significant changes for the pharmaceutical sector, especially regarding conditions of reimbursement and implementation of the claw back system. Significant changes are expected to occur in 2011 also, considering the current economic environment and the condition of the public health insurance system in Romania, especially with respect to the mode of calculation of prices for medicinal products for human use, co-payment, sales of medicinal products on Internet and also with respect to the implementation of the claw back system.
