Belgium. Country Q&A Belgium. Peter Bogaert, Covington & Burling. Country Q&A REGULATORY OVERVIEW. Life Sciences

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1 Life Sciences 2003 Belgium Belgium Peter Bogaert, Covington & Burling REGULATORY OVERVIEW 1. Please give a broad overview of the structure and funding of the national healthcare system. Belgium has a well-established and very efficient healthcare system. It combines private and official healthcare providers and is funded as part of the general social security system. Funding comes from withholdings on salaries (and similar official funding for civil servants) and social security contributions by selfemployed persons, and is supplemented by other official funds. and alcohol). The Ministry of Health has become more vigilant in enforcing the medicines rules against borderline products it considers to be covered by the medicines definition. 3. For each of the key regulators (pharmaceutical, medicinal, medical device, GMO) please give: Their name. Contact details (including website address). A summary of their areas of responsibility. Healthcare services allow patients a wide choice in selecting healthcare providers and defines the benefits they can claim. Patients often have to make a co-payment, which, at least in part, is intended to help prevent over-consumption. Coverage provided by the official system is often supplemented by optional additional private insurance. The system is facing challenges of increasing costs, which are not offset by increases in funding. This has resulted in increased pressure on healthcare providers, particularly on the pharmaceutical industry. The system is regularly revised to meet these challenges, a typical example being the increasing price lowering mechanisms for medicines for which generic copies become available. 2. What is the definition of a pharmaceutical product? Name. The Pharmaceutical Inspectorate (PI). Contact details (1). Amazone building (A), Avenue Bischoffsheimlaan 33, 1000 Brussels Director General: André Pauwels Tel: Fax: Website: Contact details (2). RAC Vesalius Boulevard Pachecolaan 19, b Brussels Director General: André Pauwels Tel: Fax: Website: Since 1998 when the national law (the Medicines Law (Wet op de geneesmiddelen- Loi sur les médicaments) of 25th March, 1964) was amended to comply with EC legislation (Directive 2001/83/EC), a medicinal product has been defined as any substance or combination of substances: Presented as having therapeutic or prophylactic properties. This definition includes a product promoted as having therapeutic properties, even if it does not actually have such properties. That may be administered with a view to restoring, correcting or modifing physiological functions or making a medical diagnosis. Whether the product is defined as a medicine depends on its intended use. There are many products, such as household products, that may be administered to influence physiological functions, but are not intended for that purpose. The administration criteria could also apply to certain foods (for example coffee Areas of responsibility. The PI is responsible for: authorising medicinal products, ensuring they are safe and effective; controlling the production of, and trade in, medicinal products; and controlling pharmacies and specialised products. Name. Commission for Reimbursement of Medicines (Commissie Tegemoetkoming Geneesmiddelen - Commission de Remboursement des Médicaments). Contact details. Riziv - Inami Avenue Tervurenlaan Brussels Tel: Fax: Website: GLOBAL COUNSEL HANDBOOKS 107

2 Belgium Life Sciences 2003 Areas of responsibility. Preparing the decision on reimbursement of medicines. Name. General Inspectorate for Prices and Competition (Algemene Inspectie van de Prijzen en de Mededinging Inspection Générale des Prix et de la Concurrence). Contact details. North Gate III Koning Albert II-laan 16 Boulevard du Roi Albert II 1000 Brussels Tel: Fax: Website: the secretariat of the Medicines Commission, which will arrange for the scientific review. The Medicines Commission submits a report to the Minister of Public Health within 180 days of receipt of a complete application if the application is not under the MRP. If the report is favourable, the Ministry of Social Affairs, Public Health and Environment will generally grant a marketing authorisation. If the opinion is unfavourable, the applicant is informed and the 180-day period is suspended, allowing the applicant to submit an additional dossier within two months. If the applicant does not reply within the latter period, the negative opinion becomes final. Areas of responsibility. Approval of prices and price increases for medicinal products. MARKETING APPROVAL AND STATE FUNDING 4. Is authorisation required for marketing approval of pharmaceutical products? If so, please give a broad overview of the authorisation process, in particular: To whom should the application be made? What are the key stages and timing of the process? Is there an abridged procedure? What fee is payable? Is authorisation given for a fixed period? If so, for how long and what is the renewal procedure? In what circumstances can authorisation be revoked? Application. A company wishing to place a medicinal product on the market must obtain a marketing authorisation from the Ministry of Public Health or an EU marketing authorisation under Regulation (EEC)2309/93. Key stages and timing. Under Regulation 2309/93, the applicant must submit an application to the European Agency for the Evaluation of Medicinal Products (EMEA) in London, which validates the application and arranges for a scientific review by the European Union Committee for Proprietary Medicinal Products (CPMP), on the basis of which the European Commission grants a marketing authorisation. To market an EMEA-authorised product in Belgium, an applicant notifies the EU authorisation to the Ministry of Public Health and submits the scientific assessment report prepared by the CPMP. If the EU authorisation procedure is not applicable, a medicinal product needs a marketing authorisation from by the Ministry of Public Health. That authorisation may be granted either by the Belgian authorities on their own, or on the basis of a marketing authorisation granted by another member state under the mutual recognition procedure (MRP) (see Question 6). The completed application is filed with the Pharmaceutical division of Ministry of Public Health, and is then passed to Within two months of receipt of the additional dossier, the Medicines Commission must submit its final report to the Minister. The latter must issue a decision within 210 days of the initial filing of the application. For an MRP application, the decision should follow within 90 days, subject to a referral by the authorities or by the authorities of another member state involved in the procedure to the CPMP for a binding community decision on specific points. In practice, the Minister has delegated signature powers to the director general of the PI. Once the application is submitted, applicants often informally approach the official who deals with the dossier. Direct contact, however, with the experts appointed by the Medicines Commission is forbidden. Abridged procedure. The Decree on Registration of Medicinal products requires a marketing authorisation application to include chemical and pharmaceutical data and results of pharmacological and toxicological tests and clinical trials. However, it does allow the following exceptions, which are based on EC provisions: if the medicinal product is essentially similar to a registered product, the person responsible for putting the original product on the market can allow reference to be made to pharmacological, toxicological and clinical documentation in the dossier covering the latter; if the active substance of the medicinal product has been used for an adequate time in medical practice (at least ten years), and has a recognised efficacy and an acceptable level of safety, the pharm-tox and clinical data can be based on scientific literature; or if the medicinal product is essentially similar to a reference product which has been authorised in the EU, in accordance with EC provisions in force, for at least ten years and is marketed in Belgium, no separate pharm-tox and clinical data are required. According to a Circular of the PI of 18th December, 2000, a medicinal product is considered to be essentially similar to a reference product where it: has the same qualitative and quantitative composition in terms of active substances; has the same pharmaceutical form; and 108 GLOBAL COUNSEL HANDBOOKS

3 Life Sciences 2003 Belgium is bio-equivalent (based on the ruling by the European Court of Justice in the Generics case (Case C-368/96, decision of 3rd December, 1998)). Fee. Please refer to the website of the PI ( Period of authorisation and renewals. Authorisation is valid for five years. An authorisation can be renewed for further five-year periods. The authorisation holder must file the renewal request at least three months before the expiry of the current authorisation period. There is a range of fees for renewing an authorisation (see Fees are not required for some modifications. Revocation. The Minister can revoke or suspend an authorisation on the following grounds: the product is harmful in normal conditions of use; the therapeutic effect is lacking; the product does not have the quantitative or qualitative composition indicated in the application; application for authorisation in Belgium, the applicant must guarantee that the application dossier is equal to the one accepted by the first member state or should indicate the supplements or changes. In the latter case the applicant has to guarantee that the summary of the product characteristics is identical to that accepted by the first member state. The applicant also requests the member state that granted the original authorisation to transfer its assessment report to the Secretariat of the Medicines Commission. The Ministry of Health normally grants the authorisation within 90 days after receiving the assessment report and will inform the member state that granted the original authorisation. If the Ministry believes that the medicinal product may present a risk to human health, it immediately informs the applicant and other member states. The Ministry explains its opinion and the possible measures to meet the shortcomings of the application. It will also attempt to reach an agreement with concerned member states. If no agreement is reached, referral is made to the CPMP in accordance with the arbitration procedure established by article 32 of Directive 2001/83. The Ministry will grant or deny the authorisation in line with the outcome of the procedure. the data in the application dossier are not accurate or have not been adequately updated; or the manufacturer does not perform the quality controls specified in the file. 7. Is there a separate procedure for determining whether the cost of a pharmaceutical product will be funded/reimbursed by the state? If so, please give details (including how pricing is determined in these circumstances). 5. Is a distinction made between over the counter drugs and drugs that can only be obtained on prescription? If so, how is the distinction made and what impact does this have on the process for authorisation? Once a product has been authorised, the Minister of Health must decide (after consultation with the Medicines Commission) whether or not it can be sold over the counter without a prescription. The Medicines Commission advises the Minister to classify a product as a prescription drug in the following cases: The product can be dangerous for a patient s health if used without a doctor s supervision. Yes, the Minister of Social Affairs decides, on the basis of a proposal by the Commission for Reimbursement of Medicines, whether to add a medicine to the list of reimbursed medicines. A company that places registered medicines on the market can ask the Commission for Reimbursement of Medicines to formulate a proposal for reimbursement. The application must be concurrent with the application for a price (see Question 8). The procedure sets specific deadlines for review of applications. The procedure should take no more than 180 days, but there is a deadline when new data is required. In the absence of a negative decision, the application is deemed to be approved. MANUFACTURE AND CLINICAL TRIALS The effects or side effects of some of its components need to be studied in more detail. The product is often used for purposes for which it is not normally intended and which could endanger human health (misuses). Products for parenteral administration are, as a rule, also only available on prescription, but there may be exceptions. 6. Is there a mutual recognition procedure? (For EU countries only.) The EC MRP applies (see Question 5). When another member state has authorised a medicinal product that is the subject of an 8. Is authorisation required to manufacture pharmaceutical products? If so, please give a broad overview of the authorisation process, in particular: To whom should the application be made? Are there any specific restrictions on foreign ownership? What are the key stages and timing of the process? What fee is payable? Is authorisation given for a fixed period? If so, for how long and what is the renewal procedure? In what circumstances can authorisation be revoked? GLOBAL COUNSEL HANDBOOKS 109

4 Belgium Life Sciences 2003 Application. Companies or individuals wishing to manufacture medicinal products or import them for manufacturing must file a dossier with the PI (see Question 3 for contact details). The following information must be included: a list of the products and preparations used in the manufacturing process; details of the manufacturing process and the address where it will be undertaken; and There is no clear legal framework for clinical trials. The rules on applications for marketing authorisation indirectly require clinical trials to be carried out in accordance with the principles of good clinical practice and the ethical rules established by the Declaration of Helsinki. The applicant must also submit a description of the proposed techniques to the ethical committee (an independent body responsible for ensuring the protection of the rights, safety and well-being of humans taking part in trials) and obtain its opinion (effectively approval) before starting the trial. evidence of adequate personnel, premises, scientific and industrial equipment necessary to comply with the principles of good manufacturing practice (GMP). The Royal Decree of 6th June, 1960 refers to detailed guidelines published by the European Commission on the interpretation of these principles. Restrictions on foreign ownership. There are no restrictions on foreign ownership. Key stages and timing. A PI officer investigates the application to ascertain whether all the requirements of the Royal Decree of 6th June, 1960 are met and whether the application dossier is complete. The officer must report its findings in writing to the Minister within 30 days of the filing. A copy of the report is also sent to the applicant. If the officer recommends rejection of the authorisation the applicant can request the Minister to submit the dossier to the Advisory Committee for reconsideration within 15 days of receipt of the rejection. If the officer recommends granting the authorisation, the Minister can still decide to reject the application after seeking advice from the Advisory Committee. The Advisory Committee must make a decision within 30 days of receipt of the dossier. The Minister must issue his final decision within 90 days of the filing of the application. Once the minister obtains authorisation, a manufacturer is obliged to comply with the principles and guidelines of GMP. A similar procedure applies for obtaining wholesaler licences. Fee. Please see the PI s website ( Period of authorisation and renewals. Authorisation is valid for five years and can be renewed at the request of the authorisation holder. The authorisation holder must file the renewal request three months before the expiry of the current authorisation. The PI should be informed of any changes to the submitted information. Revocation. If a licence holder does not respect the requirements imposed by the Decree, the Minister can suspend its licence for one to two months. If a further infringement is committed within five years of a suspension, the Minister can revoke the licence on the basis of a reasoned opinion from the Advisory Committee. PI Circular of 10th August, 2000 describes certain aspects of clinical trials. The product that is the subject of the trial is added to the list of products covered by the company s manufacturing or wholesale licence. In practice, the deadline of one month is often not met, in which case commencement of the trial is in principle blocked. A circular cannot impose new requirements on companies beyond that provided for by law (particularly Decree of 6th June, 1960). The rules will probably remain unclear until the new EC Directive 2001/20/EC on clinical trials is formally implemented. The EC Clinical Trials Directive should become fully operational by May, 2004 at the latest. PACKAGING AND LABELLING 10. Please give a broad overview of provisions relating to the packaging and labelling of pharmaceutical, biotechnology and GMO products. Directive 92/27/EEC, which harmonises the rules on labelling and package inserts within the EU and is now incorporated in Directive 2001/83, has been implemented in Belgium (various Royal Decrees, including the Royal Decree of 31st December, 1992, modifying the Royal Decree of 3rd July, 1969 on the registration of medicinal products). Article 2bis of the amended Royal Decree mirrors the content of article 2 and 3 of the Directive, listing the information that must appear on the outer packaging or, where there is none, on the immediate packaging. The information must be easily legible, comprehensible and indelibly printed in at least the three official languages used in Belgium (Dutch, French and German). If additional languages are used, the information provided must be exactly the same as that provided in the official languages. PRICING, MARKETING AND ADVERTISING 11. Are the prices of pharmaceutical products regulated? Belgium operates strict controls on pricing and reimbursement of medicines for human use. The procedures for determining prices are set out in two Ministerial Decrees dated 29th December, 1989, as amended: 9. Are clinical trials regulated? If so, please give an overview of necessary consents, authorisations and procedural requirements. The first deals with medicinal products that are reimbursed under the national health insurance system. The second deals with other medicinal products of which at least one pharmaceutical form is subject to prescription. 110 GLOBAL COUNSEL HANDBOOKS

5 Life Sciences 2003 Belgium OTC products are covered by the Ministerial Decree of 20th April, 1993, as amended. Generally, the prices of new medicinal products that will be reimbursed and price increases for existing reimbursed medicinal products require prior authorisation from the Minister of Economic Affairs (article 314 section 1 of the Act of 22nd December, 1989). The parallel imported product has the same: qualitative and quantitative composition with regard to the active ingredient; pharmaceutical form; and Applications for a price, or price increase, for reimbursed products must be submitted by the marketing authorisation holder by registered post to the General Inspectorate for Prices and Competition (GIPC) with the Ministry of Economic Affairs. The Price Commission makes a decision on the basis of a review within 90 days (subject to extensions in certain cases). If no decision is made within the deadline, the requested price is deemed approved. For non-reimbursed medicines subject to prescription, the company must notify the price to the GIPC by registered mail 30 days before use. Later price increases require approval under a procedure that is similar to that for reimbursed products. This procedure will also apply when the inspectorate does not consider this product to be new. Similar provisions apply to OTC products. 12. Are there any restrictions on marketing practices such as gifts or incentive schemes for healthcare establishments or individual medical practitioners? Are any such practices commonly used? Article 10 of the Medicines Law contains a broad prohibition on granting gifts or benefits to health professionals. In 1997, the highest civil court (Court of Cassation) took a very restrictive view of this provision and held that it also prohibits payment of services given by a physician to a pharmaceutical company, such as in phase IV clinical trial. The article was amended in August, 2002 to specifically allow that persons who may prescribe medicines may be compensated for services provided in the conduct of clinical trials or other scientific studies. therapeutic effect; as the Belgian reference product. The products are manufactured by the same producer or linked producers. The Decree further provides that the authorisation can also be granted even if: The marketing authorisation for the reference product in Belgium has lapsed. The parallel imported product is not approved in the country of exportation. There are differences between the products that are not therapeutically relevant. An application is validated by the secretariat of the Medicines Commission within ten days, and is reviewed within 30 days. If the review shows there may be therapeutically relevant differences between the parallel import product and the reference product, the Medicines Commission conducts another review within an additional 30-day period. The Minister of Health makes a final decision within a further ten days. The authorisation is valid for five years and can be renewed. The period is, however, reduced to the remaining period of validity of the reference product. Promotion of parallel imports must be limited to economic aspects (price benefit) and to reminder advertising. The importer must also notify the holder of the marketing authorisation for the reference product. The scope of the exemption is not clear and there may be several bona fide collaborations between pharmaceutical companies and physicians that are not necessarily covering scientific studies. Specific rules also apply to bribery and co-liability for breach of internal rules of healthcare establishments or of other contracts between institutions. 13. How are parallel imports regulated? Since early June, 2001, specific rules contained in theparallel Import Royal Decree of 19th April, 2001 apply. The Decree provides for the notification of parallel distribution of centrally approved medicines (Regulation 2309/93) and for a simplified authorisation procedure for parallel imports of nationally approved products. The Decree provides that a parallel import authorisation will be granted if: There is a reference product in Belgium (that is, that there is a valid marketing authorisation). 14. Is it possible to market pharmaceutical products online, by and/or mail order? EC Directive 2000/31 on e-commerce has not yet been implemented, although Belgium was obliged to do so before 17th January, However, there are general principles on dispensing medicines that severely restrict the possibilities for internet sales. Retail pharmacists must generally dispense all medicines (with specific exemptions only being granted, for example for the dispensing of samples by physicians). They must also either be ordered or dispensed in the pharmacy. In principle, these restrictions remain valid under the E-commerce Directive, which specifically excludes the delivery of products from the harmonised scope. This is also confirmed, at least preliminarily, by court decisions in Germany involving the internet distribution organised by Doc Morris from The Netherlands, but a ruling of the European Court of Justice in that case may in the near future provide extra guidance. The legal conditions for promotion of medicines on the web remain unclear. GLOBAL COUNSEL HANDBOOKS 111

6 Belgium Life Sciences Are there any restrictions on advertising pharmaceutical products (available over the counter or on prescription)? The Product Liability Directive (Directive 85/374/EEC) and the General Product Safety Directive (Directive 92/59/EEC) have been implemented. Promotion of unapproved medicines is prohibited, as well as promotion to the public of prescription-only medicines or medicines indicated for the treatment of specific diseases listed by Royal Decree (article 9, Medicines Law of 25th March, 1964). The Advertising Decree of 7th April, 1995 implements the provisions of the Advertising Directive (92/28/EEC) and only applies to medicines for human use. The Decree defines advertising in similarly broad terms as the Advertising Directive and excludes, among other things, benefits to health professionals with minimal intrinsic value. Advertising to the public must not suggest that the effects of a medicine are better than, or equivalent to, those of another treatment or medicine, which excludes most comparative advertising. Reminder advertising is allowed under the 1995 Decree. Advertising to the public on television or radio must be approved in advance in a visa. Other advertising to the public must be notified to the Ministry at least 30 days in advance. The provisions on promotion to health professionals also follow the Advertising Directive. Additional restrictions apply to products that are reimbursed under the social security system. Competitors can challenge infringements of the rules on promotion, typically by bringing an action for an injunction under the trade practices law. The legal provisions on promotion are supplemented by a code of conduct of the pharmaceutical industry association (AVGI-AGIM) (see which has its own internal enforcement procedure. PRODUCT LIABILITY AND CONSUMER PROTECTION 16. Please give a broad overview of product liability law. In particular: Under what legal provisions can liability arise (eg contract, tort, statutory)? Who is liable? Claims can generally be brought against producers, manufacturers, importers, retailers and pharmacists. Theoretically, claims for defective medicines could also be brought against the government. Product liability claims are in practice often combined with professional liability claims against the treating physician. Substantive test. Product liability for a medicinal product can arise when the product is inherently unsafe or, more frequently, when there is a production defect with a specific batch. The damage may also be caused, or increased, by the therapeutic decision of the physician or by misadministration. Most cases of product liability are settled outside the courts. Defences. The product liability law provides for the same defences as the EC Directive and includes the state of the art defence. These defences include, among other things, that: it is probable that the defect did not exist at the time of placing the product on the market; the defect is due to compliance with mandatory provisions; and the state of the art defence (that is, the state of scientific and technical knowledge at the time of marketing did not allow the defect to be discovered). However, the defences are not necessarily available when liability actions are brought on the basis of a contract or in tort. Scope of liability. The scope of strict product liability is limited to damages to the person and to personal goods. The scope of the contractual or tort liability is broader but specific limitations may also apply. Who is potentially liable for a defective product? What is the substantive test for liability? What defences are available? What is the scope of potential liability and sanctions? 17. Are class actions permitted for product liability claims? If so, how common are they? There are no specific rules on class actions. Legal provisions. There are no specific provisions on product liability for pharmaceutical products. In line with EC provisions, the marketing authorisation leaves the general civil, and possible criminal, liability of the pharmaceutical company unaffected. Liability may arise either: contractually, where the plaintiff is the purchaser of the product; or under tort liability and strict (no-fault) product liability, where the plaintiff is a third party to the transaction and suffered damages as a result of a characteristic of the product. 18. Does any regulatory body monitor compliance with authorisation and/or consumer protection regulations? If so, what are its powers? Inspectors of the PI can check compliance with the principles of good clinical practices, as well as the rules on manufacturing, distribution and promotion of medicines. The inspection procedures are still under development and will have to be formalised on implementation of the Clinical Trials Directive. 112 GLOBAL COUNSEL HANDBOOKS

7 Life Sciences 2003 Belgium INTELLECTUAL PROPERTY 19. What is the test for a pharmaceutical product to be capable of patent protection? Are there separate tests for biotechnology, medical device or GMO products? The most important intellectual property (IP) rights are patents and trade marks. Different procedures apply depending on whether the applicant is seeking patent protection only in Belgium (the national procedure) or in additional countries (the EU and international procedures). This chapter deals with the national procedure for patents valid for 20 years (simplified rules apply to six-year patents). Both medicinal products and the processes used for their preparation are patentable. To qualify for patent protection, an invention must be (article 2, the Act of 28th March, 1984): New. The result of an inventive step. Capable of industrial application. There is an administrative review of the novelty and industrial application requirements, but it is up to the courts when assessing the validity of the patent in the event of proceedings initiated by a third party, to verify whether or not the invention satisfied the prescribed requisites and was therefore eligible for protection. automatically grants patent protection. The Service for Industrial Property (SIP) reviews the application and produces an official report. The SIP then issues a research report, after which the conclusions, description and drawings may be amended, provided they remain within the scope of the original application. 18 months after the application is filed, the patent is officially granted by Ministerial Decree and published in the Register of Patents. At this stage, the file becomes public. Although the patent is protected from the filing date, the patent owner will not be able to enforce its rights until publication, subject to a right to reasonable compensation in certain circumstances. Fee. Please see the SIP website (see above). Duration of protection. Registration lasts for 20 years from the filing of the application, provided that the necessary fees are paid. Renewal process. In accordance with EC law, it is possible to obtain a supplementary protection certificate to extend the patent protection period for up to five years, under certain conditions. A technical problem can result from the extension of the EC supplementary protection certificate regime to the EEA countries. For example, a marketing authorisation in Switzerland is in principle also valid in Liechtenstein and may start eroding the five-year protection period in the EU, even when the product is not yet approved there. 20. What is the procedure for obtaining patent protection? In particular: To whom should the application be made? What are the key stages of the process and timing? What fee is payable? Revocation. A registration can be revoked if the fees are not paid. International conventions. Belgium is a party to the following international conventions and treaties governing patent law: Paris Convention for the Protection of Industrial Property of 20th March, 1883; more specifically, articles 4 and 5 of this Convention govern patent rights; For how long is protection given? What is the renewal process? In what circumstances can a patent be revoked? Is your country a party to any international conventions on patent protection? Application. Service for Industrial Property, a division of the Ministry of Economic Affairs, North Gate III, Koning Albert II-laan 16 Boulevard du Roi Albert II, 1000 Brussels Tel: Fax: Website: intellectual_property/patents/home_nl.htm Process and timing. Once the application is completed and filed, and the relevant fees paid, the competent authority Treaty of Strasbourg regarding the International Classification of Patents of 24th March, 1971; Treaty of Strasbourg regarding unification of patent law principles of 27th November, 1963; Treaty of Washington regarding patent co-operation of 19th June, 1970 (PCT Treaty); Treaty of Munich of 5th October, 1973 regarding the grant of European patents; Treaty of Luxembourg regarding the Community Patent of 15th December, 1975 (which has not yet entered into force); Treaty of Budapest regarding the international recognition of filing micro-organisms for patent protection of 28th April, 1977; Agreement on Trade-related aspects of Intellectual Property Rights of 15th April, 1994 (TRIPs). GLOBAL COUNSEL HANDBOOKS 113

8 Belgium Life Sciences Are drug patents commonly infringed? What is the process for enforcement? What is the renewal process? In what circumstances can a trade mark be revoked? Patent enforcement cases, although not frequent, are not exceptional, especially in case of generics competition. There are three ways to enforce patents. A patent owner can file: A petition for descriptive seizure of the alleged counterfeited goods with the seizure judge. Descriptive seizure will be granted, provided the alleged IP right of the petitioner seems valid at first sight, and there are reasonable indications of infringement. This procedure is particularly important for patent owners because it facilitates the action on the merits, which needs to be lodged within one month after the expert s report has been filed, failing which the descriptive seizure is automatically annulled. A petition for interim measures (summary proceedings), in urgent cases, to protect its interests. The applicant normally files a petition for descriptive seizure (see above) before initiating an action on the merits. An action on the merits and request for various measures, such as a cease order ending the infringement, confiscation of the counterfeited goods and production assets, as well as damages. 22. Can the brand of a pharmaceutical/medical device/gmo product be protected by registration as a trade mark? If so, what is the test for obtaining trade mark protection? It is possible to obtain trade mark protection either via a Benelux registration, an EC registration or an international registration. The Benelux procedure is set out in the Law of 19th March, 1962 (Eenvormige Beneluxwet op de merken - Loi uniforme Benelux sur les marques). Obtaining trade mark protection for a product name does not guarantee that the name can be used for a specific medicine. There may be public health reasons preventing this, in particular the risk of a misleading implied meaning in the name, or the risk of confusion with other medicines when prescribing or dispensing it (although here the authorities may use the three-letter rule of thumb, meaning there is normally no confusion when the name differs by at least three letters from names of other products). Is your country a party to any international conventions on trade mark protection? Application. Applications for a Benelux Trade Mark can be filed with the Benelux Trade Mark Office (BTO): Contact details. Benelux Trade Mark Office, PO Box 90404, NL-2509 LK, The Hague Bordewijklaan 15, NL-2591 XR The Hague Tel: Fax: info@bmb-bbm.org Website: An application for a Community Trade Mark (CTM) can be filed with the Office for the Internal Market (OHIM): Contact details. OHIM Avenida de Europa, 4 E Alicante Spain Tel: +31/70/ Fax : +31/70/ Switchboard: General inquiries tel: General inquiries fax: Fax for correspondence relating to EU trade marks: Website: Process and timing. This depends on the method used for obtaining protection: Benelux trade mark. The written application is submitted to a national office or the BTO, which investigates whether the application meets the requirements of trade mark protection. For an application to be acceptable, an availability search must also be performed. This search can be conducted simultaneously with the trade mark application or beforehand. From the date of the search report the applicant has a maximum of: - three months to submit its application, if a search was conducted without an application being filed at the same time; or 23. What is the procedure for obtaining registration of a trade mark? In particular: To whom should the application be made? What are the key stages of the process and timing? What fee is payable? For how long is protection given? - six months to confirm its application in writing from the date on which the search report is sent, when a search is conducted with an application being filed at the same time. If the trade mark application is approved, the BTO will register the trade mark, and a publication will be made in the monthly issued magazine Benelux Merkenblad. CTM. A CTM can be filed either with: 114 GLOBAL COUNSEL HANDBOOKS

9 Life Sciences 2003 Belgium - OHIM; - any of the central industrial property offices of the member states; or - BTO. If the application does not contain all the required documents and information, the OHIM will issue an invitation to comply with all requirements within a twomonth period. The OHIM will then investigate whether the application meets the requirements of trade mark protection. For an application to be acceptable, an availability search will be performed. If approved, the CTM will be published and third parties can oppose registration. If no (successful) opposition is made, the CTM will be registered. International trade mark registration. The Madrid system of international registration marks is governed by two treaties: - the Madrid Agreement Concerning the International Registration of Marks from 1891; and - the Protocol relating to the Madrid Agreement, which entered into force on 1st April, The system is administered by the International Bureau of the World Intellectual Property Organisation (WIPO) in Geneva. An application for international registration must be presented to the International Bureau through the Industrial Property Office (Patent Office) of the country of origin. The Madrid Agreement and the Madrid Protocol are parallel but independent treaties, with different but overlapping memberships. The provisions of the Agreement and the Protocol significantly differ and so it is important to decide before an international filing on the most convenient application procedure. More information can be found at protection of a foreign trade mark in the country of origin was cancelled; the trade mark was not effectively used for a certain period; the trade mark became generic; or the trade mark is invalid because it does not meet the conditions of protection. Similar reasons for revocation apply to CTMs and for international filings. International conventions. Uniform Benelux Law on Marks of 19th March, 1962; Council Regulation (EC) 40/94 of 20th December, 1993 on the CTM; Commission Regulation (EC) 2868/95 of 13th December, 1995 implementing Council Regulation 40/94 on the CTM; Commission Regulation (EC) 216/96 of 5th February, 1996 laying down the rules of procedure of the Boards of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs); First Council Directive 89/104 of 21st December, 1988 to approximate the laws of the member states relating to trade marks; Madrid Agreement concerning the International Registration of Marks, 1891; Madrid Agreement concerning the International Registration of Marks, Protocol, 1989; and Madrid Agreement concerning the International Registration of Marks, and the Protocol, Common Regulations. Fee. Please refer to the following websites: Benelux trade mark: index.htm. CTM: International trade mark registration: Duration of protection. A Benelux or CTM registration is effective for ten years. Renewal process. A Benelux and CTM registration can be renewed for further ten-year period on payment of the prescribed fees. Revocation. A Benelux trade mark can be revoked if: 24. What is the process for enforcing brand or trade mark infringement? Benelux trade marks can be enforced through various proceedings: Summary proceedings (interim measures). Action on the merits. Injunction proceedings on the merits. Similar procedures can be used to enforce CTM and international trade marks. EU Regulation 40/94 on CTMs provides for opposition procedures regarding CTMs. Proprietors of an earlier trade mark can oppose registration of a CTM, within a three-month period following the publication of a CTM application, if: the fees are not paid; It is identical with the earlier trade mark, and the goods or services for which registration is applied for are identical GLOBAL COUNSEL HANDBOOKS 115

10 Belgium Life Sciences 2003 with the goods and services for which the earlier trade mark is protected; and There is likelihood of confusion in the territory in which the earlier trade mark is protected regarding its identity with, or similarity to, the earlier trade mark, and the identity or similarity of the goods or services covered by the trade marks. HOMEOPATHIC PRODUCTS 25. Are homeopathic products specifically regulated? If so, please give details. All medicinal products, including homeopathic products, are subject to the provisions of Royal Decree of 3rd July, 1969 on the registration of medicinal products. However, homeopathic preparations that meet specific conditions (such as high dilution) can benefit from a simplified registration procedure (article 28bis, the Decree on registration of medicinal products). Under the simplified procedure, a short-form application can be filed and specific rules may also apply to other homeopathic products. Homeopathic products that do not qualify for the simplified procedure must be approved under the normal rules for marketing authorisations. However, member states may provide for other standards for pharmacological, toxicological and clinical data (article 16.2, the Human Use Directive 2001/83). Royal Decree of 3rd July, 1969 was amended in light of the above directive in A specialised Homeopathics Commission has been appointed, but there is currently insufficient experience with the simplified procedure to judge its success. For other homeopathic products, specific provisions remain to be adopted on what data is required. A Ministerial circular No 420 of 28th June, 2002 describes in details the rules regarding the notification of existing homeopathic products to the PI. DEVELOPMENTS 26. Please summarise any impending developments in the field of life sciences (regulatory/legal/popular). There remains pressure to lower the cost of medicines to the social security system. As from mid 2003, the reimbursement level of products for which generics are available is dropping by 26% of the basic ex-factory price. On the other hand, in June, 2002 a law was adopted providing for a maximum co-payment of patients and their families for more serious healthcare during each year. The developments at EU-level will effect the regulatory environment, and include the: Ongoing revision of the pharmaceutical legislation. Discussions on comparable biotechnology products. Product reviews before the CPMP. Increasing possibilities for judicial review before the European courts. Practicenotes@practicallaw.com over 500 transaction guidance notes written by leading practitioners and updated regularly by PLC editors For further information, call subscriptions on +44 (0) or by to subscriptions@practicallaw.com 116 GLOBAL COUNSEL HANDBOOKS