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URÍA & MENÉNDEZ
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The information contained in this Newsletter is of a general nature and does not constitute legal advice © 2002-2003 Uría&Menéndez y Abogados, S.C. All Rights Reserved. |
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TMTTELECOMMUNICATIONSNew Reference Interconnection OfferThe Telecommunications Market Commission (“CMT”), by Order of 10 July 2003, modified relevant aspects of the Reference Interconnection Offer (“OIR”) such as, inter alia, interconnection capacity, interconnection agreements between operators and prices applicable to intelligent network services and short number services. (More information) List of “main operators” in the Spanish fixed and mobile telephony marketsAs it does every year, the CMT has published the list of operators considered as “main operators” within the national markets of fixed and mobile telephony, in accordance with Article 34 of Royal Decree-law 6/2000, of 23 June. (More information) AUDIO-VISUALTV broadcasting services on conditional accessA decision of the Supreme Court, of 12 June 2003, states that any individual who has undergone damages deriving from a legislative act contrary to EC Law is entitled to compensation. In the case at hand, the harmful legislative act refers to certain provisions of Royal Decree 1/1997, of 31 January and Law 17/1997, of 3 May. These rules included several restrictions concerning the conditional access systems (or “decoder systems”) that were used by digital TV operators under Spanish Law. Measures to foment and promote cinematographyRoyal Decree 526/2002, of 14 June, sets out incentives for independent cinematographic productions as well as certain measures to ensure diversity in the films exhibited. Due to the variety of public subsidies existing in this area, the Ministry for Education, Culture and Sports issued the Order of 22 July, setting out the procedures for accessing these public subsidies. This rule will assist applicants in speeding up the procedures and formalities involved in obtaining each of the said subsidies. (More information) INTELLECTUAL PROPERTYThe Spanish Parliament has passed the Act for the Legal Protection of Industrial DesignsIn July 2003, new Spanish regulations on Industrial Designs were approved, that supersede the scarce rules contained in the former Industrial Property Act of 1929 (“Estatuto de la Propiedad Industrial”) which were still in force. (More information) COPYRIGHT“Taylor-made” computer softwareThe Supreme Court appears to establish the obligation of the developers of “Taylor-made” software to provide the Source Code to purchasers. (More information) New EU Regulation on Prevention of Importation of Infringing GoodsThe EU has approved a new Regulation on the necessary conditions to prevent the import of goods infringing Intellectual Property rights, which supersedes the former provisions on this subject. (More information) PHARMACEUTICAL LAWNew structure of the Ministry of Health and ConsumptionRoyal Decree 1087/2003 of 29 August sets out the structure of the Ministry of Health and Consumption further to the entry into force of Law 16/2003, of 28 May, of Unity and Quality of the National Health System. This regulation creates the Agency for the Quality of the National Health System, and the Health Information Institute. Moreover, the duties of the General Pharmacy Directorate and the Spanish Agency of Medicines and Pharmaceutical Products are reorganized. Medicine home delivery service for chronic patients, upon a previous sale at the chemist’s with a medical prescriptionThe Spanish Constitutional Court has adopted a decision on the constitutional compliance of certain Articles of Law 5/1999 of the Galician Autonomous Parliament, of 21 May 1999, on Pharmaceutical Regulation, whose constitutional compliance had been questioned by the Government. The Court declared the constitutional compliance of the provision that entitles chemists to home deliver medicines to chronic patients using courier delivery services, provided that a previous dispensation at that chemist’s has been made, where medical prescription has been presented. (More information) Parallel importation of medicinesAdvocate General Tizzano considers that, in the cases of parallel importation of medicines between EU Members, the marketing authorization granted by the State of importation may be extended to an imported pharmaceutical product if it was authorized on the State of origin and may be considered essentially equal to the one marketed on the State of importation. A requirement whereby the active element of both pharmaceutical specialities must be made by companies of the same group or under an agreement executed with the same licensor is additional and different from the requirement referred to the essential equality. Therefore, imposing such additional requirement is considered to be a potential obstacle to the free movement of medicines within the EU, which could only be justified by reasons of public health. (More information) Commission Communication on medical devicesThis Communication contains a report about the implementation of Directive 93/42/EEC, on medical devices, regarding surveillance, clinic investigation and consultation to the competent bodies on medical devices, and also contains the conclusions of an analysis on this legislative framework reached by the Commission Expert Group. (More information) European Commission Communication on orphan drugsThis Communication analyzes certain issues referred to the European Parliament and Commission Regulation CE 141/2000, on orphan drugs, regarding designation and Registry removal procedures and marketing authorisations. (More information) Other legislative news on pharmaceutical matters– Resolution of the General Health Secretary, of 15 July 2003, publishing the Pharmaceutical Vigilance Agreement executed between the Spanish Medicines Agency (Ministry of Health and Consumption) and the Health Council of the Autonomous Region of Andalusia (published in the BOE of 6 August 2003). – Resolution of the General Health Secretary, of 15 July 2003, publishing the Pharmaceutical Vigilance Agreement into by and between the Spanish Medicines Agency (Ministry of Health and Consumption) and the Health Council of the Autonomous Region of Castilla-La Mancha (published in the BOE of 6 August, 2003). – Resolution of the General Health Secretary, of 15 July 2003, publishing the Pharmaceutical Vigilance Agreement into by and between the Spanish Medicines Agency (Ministry of Health and Consumption) and the Health Council of the Autonomous Region of Madrid (published in the BOE of 6 August, 2003). – Resolution of the Spanish Medicines Agency, of 18 July 2003, publishing the authorized and registered medicinal products on the second quarter of 2003 (published in the BOE of August 4, 2003). – Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2003 to 15 July 2003 (EU Official Journal C176 of 25 July 2003). – Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2003 to 15 August 2003 (EU Official Journal C204 of 29 August 2003). FOOD LAWThe mere presence of genetically modified organisms in novel foods does not rule out their substantial equivalence to existing foodsThe European Court of Justice states that the mere presence of genetically modified organisms in novel foods does not rule out their substantial equivalence to existing foods, nor the possibility to use the simplified procedure for the authorisation of their placing on the market. (More information) Use of photographs and illustrations as health warnings on tobacco packages.The European Commission has set out certain rules to be followed by the Member States that decide to use photographs and illustrations as health warnings on tobacco packages. (More information)
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CMT Decision of 10 July 2003, on the modification of the Reference Interconnection Offer applicable to Telefónica de España, S.A.U. (published in the BOE of 21 July 2003)
The mentioned Decision introduces several changes to the Reference Interconnection Offer (“OIR”) applicable to Telefónica de España, S.A.U. (“Telefónica”), of which the following are of particular interest:
Interconnection agreements: the Decision introduces a model interconnection agreement between Telefónica and the operator requesting interconnection, so that this may take effect by the simple acceptance of the text of the agreement;
Short numbers: the Decision details the scheme applicable to the conditions and prices of interconnection for the provision of short number services (particularly the access to telephone information services on subscribers´ telephone numbers -rank 118AB-);
Capacity interconnection: the Decision regulates for the first time the possibilities available to interconnected operators in situations of capacity overflow at each Interconnection Point. In this way, each interconnected operator will be able to decide whether to contract alternatives in order to direct the calls that do not find resources in the capacity links or whether, on the contrary, these calls should be refused; and
Intelligent network: the Decision establishes for the first time that the operator who must pay for the transit service for telephone calls to the 800 and 900 numbers is the intelligent network operator, whereas, in the case of other calls, the person who must pay for the service varies depending on the interconnection model selected by each operator: the intelligent operator pays for the transit service in the access interconnection model and the access operator pays for the service in the termination interconnection model.
The Decision also establishes for the first time that the added value part of the telephone calls to premium rate intelligent network numbers is not paid for interconnection until the access operator has received the amount corresponding to the subscriber.
CMT Decision of 26 June 2003
By virtue of the mentioned Decision, the CMT has established, as it does every year, the list of operators considered as “main operators” within the national markets of fixed and mobile telephony. This list imposes certain restrictions on these operators as set out in Article 34 of the Royal Decree-law. This Article establishes that individuals or companies that are shareholders with voting rights equivalent to three per cent (3%) or more of the total capital, or voting rights of more than one company considered as a main operator within the same market or sector, shall not be able to exercise more than three per cent (3%) of the relevant voting rights in more than one of those companies. In the same way, individuals or companies considered as “main operators” shall not be able to appoint, directly or indirectly, members of the management body of companies considered as “main operators” in the same market or sector. All operators affected by these restrictions are also subject to the obligation to communicate to the CMT, within a month following the appearance of the situation causing the restrictions, the company with respect to which they are trying to exercise voting rights or appoint members of the management body without restriction.
Section two of Article 34 defines “main operator” as “anyone who is an operator in those markets or sectors, and has one of the five biggest market shares”. This Article refers to fixed and mobile telephony markets, among others.
The CMT ratifies the criterion used in order to determine the “main operators” of 2001, interpreting the term “main operator” as a group of companies as a whole and not as the company that renders its services in the relevant market.
Consequently, after analysing the market shares of the different operators having regard to the total annual turnover in commercial dealings, the CMT declared as “main operators” in the fixed telephony market the following groups of companies: Telefónica Group (Telefónica de España, S.A.U., Telefónica Cable, S.A.U., Telefónica Data España, S.A.U. y Telefónica Móviles España, S.A.U.), Auna Group (Auna Telecomunicaciones, S.A.), UNI2-France Telecom Group (UNI2 Telecomunicaciones, S.A.U. y Catalana de Telecomunicaciones, Societat Operadora de Cableuropa, S.A., Mediterránea Norte Sistemas de Cable, S.A., Mediterránea Sur Sistemas de Cable, S.A., Ononet Comunicaciones, S.A.U., Región de Murcia del Cable, S.A. y Valencia del Cable, S.A.). Likewise, the CMT has declared as “main operators” in the mobile telephony market the following groups of companies: Telefónica Group (Telefónica Móviles de España, S.A.U.), Vodafone Group (Vodafone España, S.A.), Auna Group (Retevisión Móvil, S.A.) and Xfera Group (Xfera Móviles, S.A.).
Order of the Ministry for Education, Culture and Sports, of 22 July, providing rules for the application of Royal Decree 526/2002, of 14 June (published in the BOE of 7 August 2003)
Royal Decree 526/2002, of 14 June, sets out incentives for independent cinematographic productions as well as certain measures to ensure diversity in the films shown. Due to the variety of public subsidies existing in this area, the Ministry for Education, Culture and Sports issued this Order of 22 July 2003 setting out the procedures for accessing these public subsidies. This rule will assist applicants in speeding up the procedures and formalities involved in obtaining each of the said subsidies.
In particular, the Order covers aspects such as Nationality Certificates for Spanish films and audiovisual productions, assistance in the production, broadcasting, conservation and promotion of said films and productions in film festivals, including the writing of scripts for these works, together with assistance in the organization of festivals and cinematographic contests in Spain.
The rules of the Order must be construed within the framework with the rules governing other aids, incentives and subsidies that may be provided by the different Autonomous Communities within the scope of their powers.
Law 20/2003, of 7 July, for the Legal Protection of Industrial Designs (published in the BOE of 8 July 2003)
In July 2003, a new Spanish Act on Industrial Designs was approved, that supersede the scarce rules contained in the former Industrial Property Act of 1929 (“Estatuto de la Propiedad Industrial”) which were still in force.
This new Act incorporates into Spanish law the Directive 98/71/EC of the European Parliament and the Council, on the Legal Protection of Designs and Models, referred to jointly as “Designs” by the new Act and which consist of the bi-dimensional (designs) or tri-dimensional (models) appearance of a product, derived from the characteristics of the outline, shape, colours, form, texture and materials of the product itself or its ornamentation.
According to the new Act, the objective requirements for the protection of these Designs and Models are, namely, their novelty and their singular nature: the protection, obtained by means of their registration, is given to those Designs that give to the well-informed user a global impression that is considerably different to that of other designs, and is not known to the specialized professional in the relevant sector. It should be noted that the designs will continue to be considered as new for a period of twelve months after being divulged by their author.
Another new development is the modification of the administrative procedure for public concessions, which, according to the relevant rule seeks to find a combination between speed of concession and the necessary legal security required in the design industry, along with the protection of the general interests and the rights of third parties.
These objectives are to be met by a system called “oposición post-concesión”, which consists of the granting of the registration after a simple ex officio examination of the request, in order to make sure it is a Design and it is not contrary to public order or good practice. After publication of this registration, the postponement of which may be requested for a maximum period of thirty months, the design shall be fully effective. A period of opposition is then opened for interested third parties including interested Professional Associations, on the basis of previous rights or causes for denial that may not have been examined ex officio by the competent Authority.
The registration of the Design provides its owner with the exclusive right to use it and also the possibility to prohibit its use by others. The registration has a duration of five years from the day of request, and may be renewed for one or more successive periods up to a total of twenty five years.
The legal regulation of the Design as an item of property is limited to the contractual aspects, in the sense that the parties have not made use of their capacity to negotiate. The regulation of Actions in defence of rights follows the model of analogous regulations such as the Trademarks Act and the Patents Act.
It is worth noting that the effects of this Act will exist alongside the uniform effects of community designs throughout the European Union, regulated under Regulation 6/2002 of the Council, on Community Designs and Models, which includes both registered and non-registered designs (for non-registered designs, the protection is limited to three years from the day of the first divulgence and it may not be renewed).
Decision of the Supreme Court, Civil Chamber (Tribunal Supremo, Sala de lo Civil), of 17 May, 2003
The Supreme Court ruled on an appeal originating from a compensation claim arising from the breach of a “Taylor Made” Software Development Contract.
The breach concerned, among other matters, the purveyor’s refusal to provide the purchaser with the “source code” of the software program.
According to the Court, given that the responsibility for the expenses of the development of the program had been assumed by the purchaser, its “future feasibility cannot be left to the simple interest, whim or fickleness of the supplier”, and the supplier is therefore obliged to provide the source code of the program to the purchaser, since that code is necessary to update and improve the program. These acts of improvement or updating, according to the Court, are necessary for the use of a “Taylor-made” program by its legitimate owner according to a previously agreed purpose, and that is the reason why there is no need for authorization from the author of the program, as provided in the current Article 100.1 of the Intellectual Property Act, cited by the Court.
Without prejudice to the foregoing, it is not clear whether this line of reasoning may be applicable to cases where, differently from that analysed in this judgement, the delivery of the source code has been expressly excluded in the contract (the aforesaid Article excludes, in particular, the cases where a contractual provision provides otherwise). The contents of this judgment could lead to confusion on their concrete reach in this respect.
Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (EU Official Journal L196 of 2 August 2003)
This new Regulation concerns issues relating to the prevention of importation of goods infringing Intellectual Property rights, repealing and replacing EC Regulation 3295/1994.
The main new developments introduced by this Regulation with regard to the above are the following: (i) the scope of application of the Regulation is widened to include more rights (i.e. vegetable varieties, geographic indications, and designations of origin); (ii) the Regulation seeks, as the preparatory work reveals, to achieve a fuller and more flexible exchange of information between the customs authorities and the rights owners; (iii) the Regulation restricts the rules and guarantees for filing a request for intervention; and (iv) it enlarges the scope of application of the ex officio procedure.
Decision of the Constitutional Court 152/2003 of 17 July 2003 (published in the BOE of 13 August 2003)
In an appeal to the Constitutional Court filed by the President of the Spanish Government, the Court analyzed certain Articles of the Law 5/1999, of the Galician Autonomous Parliament, of 21 May 1999, on Pharmaceutical Regulations, dealing with: (a) medicine home delivery service for chronic patients; (b) authorisations necessary for the opening and running of chemist’s; and (c) regulation of the activity of type II radiopharma units and their authorization.
Point (a) is worth a special reference, particularly concerning the constitutional analysis of Article 4.3 of Law 5/1999. This Article states that chemist’s, under certain legal conditions, are entitled to deliver medicines periodically to chronic patients if there has been a previous sale at the chemist’s with a medical prescription, either using their own delivery services or others.
The government argued that the mentioned Article should be declared unconstitutional, and therefore null and void, since (a) the central government has exclusive jurisdiction over matters related to “pharmaceutical products”, and (b) Article 3.4 of the Medicines Law forbids any kind of home delivery of medicines.
The Constitutional Court rejected both arguments on the basis that Article 4.3 of Law 5/1999 is not related to “pharmaceutical products” but to “pharmaceutical planning” or “pharmaceutical establishments”, with respect to which Autonomous Regions are empowered to legislate. The Court finds that those matters concern the delivery of ordinary medicines by chemist’s and do not affect the health protection guarantees, which fall within the exclusive jurisdiction of the central government. One of these guarantees consists of the obligation to present a medical prescription before the medicine is sold, and that guarantee still exists according to Article 4.3 of Law 5/1999.
The Court ruled that in the end the fact that medicines are delivered by courier services cannot be considered a door-to-door sale, forbidden by the Medicines Law, since delivery is made by a chemist’s after a medical prescription has been presented.
Conclusions of Advocate General Tizzano, of 11 September 2003, in the case of Kolpharma GmbH vs. Federal Republic of Germany
The medicinal products Jumex and Movergan, which share the same active element, are marketed by two different laboratories in Italy and Germany respectively. The active element of both medicines is produced by the same laboratory, but whilst the laboratory that markets Jumex obtains the active element further to a license agreement, the laboratory that markets Movergan does so according to a supply agreement.
In view of the identity of the active element, Kolpharma GmbH asked the German authority to extend the authorisation to market Movergan in the German territory so as to include Jumex, therefore enabling the importation of Jumex into Germany. However, the German authority, citing the Smith & Nephew vs Primecrown judgement, rejected this request stating that it is necessary for such extension that both products have the “same origin”, which means that both manufacturers must belong to the same group of companies or, at least, market the medicines according to a licence agreement with the same licensor (which was not the case).
Kolpharma appealed against this refusal arguing that the “same origin” requirement was not necessary in this particular case, since the two pharmaceutical products are essentially the same. As a consequence of such appeal, the German authority suspended the proceedings and referred to the European Court of Justice for a preliminary ruling on whether Article 30 EC Treaty entitled the German authority to prevent parallel importation by denying the commercialization authorization through the simplified procedure in this case, or whether this was prohibited by Article 28 EC Treaty.
The Advocate General stated that in the case of parallel importation of medicines between member States, the imported pharmaceutical product may benefit from the commercialization authorization granted by the importing State to another pharmaceutical product, provided that the former (a) has a commercialization authorization granted by the State of origin and (b) may be considered identical or essentially identical to the one commercialized in the importing State. Although the “same origin” of the two pharmaceutical products constitutes evidence of the products’ equality, this amounts to an additional requirement; and imposing this additional requirement must be regarded as a potential obstacle to the free circulation of medicines between member States contrary to Article 28 EC Treaty, which could only be justified on grounds of public health.
Commission Communication COM (2003) 386, of 2 July to the European Council and the European Parliament regarding medical devices
This Communication contains a report on the implementation of Directive 93/42/EEC on health products, relating to vigilance, clinical investigation and consultation of the appropriate authorities on pharmaceutical product matters, and also contains the conclusions on the regulatory framework developed by the expert group on medical devices at the Commission.
The Communication acknowledges the importance of medical devices in the healthcare sector, both in market terms and in terms of their impact on public health, as well as their influence on public expenditure. However, given that there is no complete and detailed information, the Commission plans to carry out a study of the sector, with the cooperation of national authorities and interested parties, its impact on public health expenditure, and the conditions to increase competitiveness.
The Commission considers that the legal framework on medical devices (comprising the Directive on active implantable medical devices, the Directive on in vitro diagnostic medical devices, and the Directive on medical devices in general) is stable and appropriate as regards security and technological evolution, although it is necessary to improve its application and standardize certain specific aspects.
In particular, improvements in implementation application of this regulatory framework should be achieved through a complete action programme involving all actors, based on different means, particularly: (a) national implementation measures (including market surveillance and the designation of notified bodies); (b) the use of instruments established in the Directives (re-classification, precautionary principle, safeguard clause, formal objection to standards); (c) preparation of guidance documents for the implementation of the Directives; and (d) the participation in coordination activities in different areas, including a new high-level group on medical devices
Finally, the annexes to the Communication provide information about the sector regarding coverage of medical devices, the benefits of medical technology and health products for EU citizens, the main aspects of the regulatory framework and certain details about the working groups relating to the application of the Directives on medical devices.
Communication from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products
The Communication analyzes certain issues relating to criteria for designation (Article 3), the procedure for designation and removal from the Register, (Article 5) and the Community marketing authorisation (Article 7) of EC Regulation 141/2000 of the European Parliament and the Commission, on orphan medicinal products (i.e. those drugs which are (a) intended for diagnosis, prevention or treatment of life-threatening conditions or those which involve chronic incapacity, not affecting more than five out of ten thousand people in the Community, or whose commercialization without any incentive would be unprofitable; provided that (b) there are no satisfactory methods for its diagnosis, prevention or treatment, or, if those methods exist, the medicine would be of considerable benefit to its consumers).
As regards the criteria for designation contained in the definition of orphan medicinal products provided in Article 3.1 of the Regulation, the Commission clarifies certain matters regarding the prevalence of the condition, the estimation of the affected population in relation to diagnostic or preventative medicines, the meaning of “satisfactory methods”, and the necessary “considerable benefit” that the orphan drug must have.
On the other hand, the Regulation establishes the possibility of cancelling the registration of a medicine declared as an orphan drug by the European orphan drug Registry when it is verified, before the commercialization authorization is granted, that this medicine does not comply with the mentioned criteria for designation. The Commission states that the developer must justify the compliance with these requirements at the time of the request for the commercialization authorization, which will be evaluated by the orphan drug Committee before the commercialization authorization is granted, revalidating or cancelling the information at the Registry as the case may be.
On the other hand, per the Regulation, there is a possibility to remove a medicinal product designated as orphan from the Registry, if it is established before the market authorisation is granted that the criteria for designation are no longer met in respect of such medicinal product. In this regard, the Commissions states that, when a sponsor submits an application for marketing authorisation for a designated orphan medicinal product, that shall be assessed by the Committee on Orphan Medicinal Products, he/she shall evidence the current fulfilment of these criteria prior to the granting of such authorisation, in order to proceed to the renewal or cancellation of the registration, as applicable.
Finally, the Commission analyzes the operation of the benefit of commercial exclusivity granted to orphan medicinal products by the Regulation, in the cases where two applications for marketing authorisation for the same orphan condition with respect to similar designated orphan medicinal products exist, both in the cases where such two applications follow the centralised procedure, as if either one, or both of them, follows a domestic procedure. The Commission also deals with new orphan indications granted to an authorised orphan medicinal product, and with the existence of different orphan indications granted to similar orphan medicines with different sponsors, as well as the review and removal of such benefit of market exclusivity.
Judgement of the European Court of Justice of 9 September 2003, Monsanto Agricoltura Italia SpA and others vs. Presidenza del Consiglio dei Ministri and others, Case C- 236/01
Within the framework of a question referred for preliminary ruling raised by an Italian Court, the European Court of Justice analysed, among other aspects, whether foods containing genetically modified organisms may be considered as substantially equivalent to existing foods. This assessment is relevant with regard to their placing on the market pursuant to Regulation no. 258/97, on novel foods and novel food ingredients: whereas, in general, placing new foods on the market is subject to a preliminary evaluation of their safety by the competent authority, and may be subject to a prior authorisation, foods which are essentially equivalent to existing foods follow a simplified notification procedure.
Certain Member States alleged that the presence of strange proteins in new food precludes those foods from being considered substantially equivalent to existing foods. In this respect, the Court of Justice stated that the mere presence of genetically modified proteins in new foods at certain levels does not preclude them being considered as equivalent to existing foods and, therefore, the simplified procedure may be followed in order to place them on the market. Although the simplified procedure does not entail a complete evaluation of the risks of the new food, the Court considered that the procedure includes sufficient elements to guarantee a high level of protection of human health and the environment, provided that the essential equivalence with pre-existing food has been determined on the basis of generally recognized and available scientific data, or by the competent authority of the relevant Member States specialized in the evaluation of risks created by new food.
On the other hand, the Court declared that the legitimate use of the simplified procedure by a Member State does not involve the authorisation of the Commission for the marketing of the food in question, not even tacit, provided that its intervention in that procedure is limited to the reception, transmission and publication of the notifications regarding the commercialization of such food. Therefore, the rest of the Member States may suspend the commercialization and use of such food without being obliged to question beforehand the regularity of the use of the simplified procedure for its marketing, provided that the adoption of these measures is a consequence of new information resulting from the available scientific knowledge, which provides justified grounds to consider that the use of such food carries a danger to human health or the environment.
Commission Decision of 5 September 2003 on the use of colour photographs or other illustrations as health warnings on tobacco packages (EU Official Journal L 226, of 10 September 2003)
The European Commission, having regard to Article 5.3 of Directive 2001/37/EC, sets out in this Decision the rules for the use of photographs on tobacco packages to describe and explain the health risks related to smoking, applicable to all kinds of tobacco products except for tobacco for oral use and other smokeless tobacco products.
Member States who decide to require the use of these health warnings will have to adopt and publish the necessary provisions to comply with this Decision, setting out an adequate transitional period to allow the relevant changes to be made in the production and packaging process of tobacco products, which under no circumstances shall be applied before 1 October 2004.
In particular, the photographs or illustrations used will have to be chosen from a library which will be provided by the Commission before 30 September 2004, and they may be accompanied by a reference to the issuing authority, including logos and contact telephone numbers of quit-smoking programmes.
The Commission is concerned about the visual integrity of the warnings and states that they must be irremovably printed and indelible, in a way that they are not hidden or separated by other indications or images, including the tax stamp, and that they are not deteriorated by the opening of the packet. In addition, the Commission, who is aware of a developing practice, stated that member States must adopt the necessary rules to prevent the use of any type of wrapper, pouch, jacket, box or other device from partially or entirely hiding or separating the warnings or any of their elements.