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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 |
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TMTTELECOMMUNICATIONSNew General Telecommunications ActAct 32/2003, of November 3, the General Telecommunications Act (“GTA”), incorporates into Spanish internal law the so-called “Telecom Directives package” approved at Community level in 2002, in order to move forward the process of liberalisation of the telecommunications market. The GTA establishes a more flexible system for the provision of electronic communications services and the establishment of electronic communications networks, but a harsher system of infringements and penalties. (More information) Legislative aspects applicable to broadband telecommunications services using PLC technology (“power line communications”)The National Energy Commission (“CNE”), answering an enquiry of the Telecommunications Market Commission (“CMT”) and after analysing the possible repercussions of PLC technology, has declared itself to be in favour of the provision of broadband telecommunications services via PLC technology, provided that the operators entitled to render it comply with the regulations of the power and telecommunications sector. (More information) Proceeding for the supply of clients’ data in order to provide directory services under a competition regimeBy Administrative Rule 2/2003, of September 26, the CMT sets out the proceeding for the reception and supply of clients’ data in order to provide directory services under a competition regime. (More information) Price liberalisation of the retail ADSL services of Telefónica de EspañaThe Delegate Commission for Economic Affairs (DCEA) approved the price liberalisation of the retail ADSL services of Telefónica de España in order to give access to the retail broadband. (More information) ELECTRONIC COMMERCEModification of the Law on Information Society Services and Electronic CommerceThe First Final Provision (Disposición Final Primera) of the new General Telecommunications Act modifies certain precepts of Law 34/2002 on Information Society Services and Electronic Commerce, especially with regard to unrequested commercial communications sent by e-mail, SMS or any other equivalent forms of electronic communication (“spamming”). This modification incorporates into our legal system the provisions of European Directive 2002/58/CE concerning the processing of personal data and the protection of privacy in the electronic communications sector. (More information) COPYRIGHTVideogames characters protection and moral damagesThe publication of a sex oriented report in which the model appears disguised as a well known videogame character, altogether with altered images of the latter, amounts to a breach of the moral and economical author rights on the character, according to the Barcelona Provincial Court. (More information) PHARMACEUTICAL LAWOrder implementing the new reference price systemThe Order implementing the new reference price system, introduced after the modification of Article 94.6 of the Medicines Act, establishes the composition of the new groups of medicinal products and their respective reference prices. Furthermore, it sets forth substitution rules of the prescribed medicinal product whenever its price is higher than the reference price of the relevant group, and dispensation rules in the cases where no branded product is prescribed. (More information) Pharmacies’ monthly invoicing criteriaRoyal Decree 1328/2003, of 24 October 2003, modifies Royal Decree 165/1997, of 7 February 1997, which establishes the relevant margins for public dispensation of medicines for human use. Such amendment, applicable to medicinal products with ex factory prices above 78.34 Euros, consists of excluding from a discount scale applicable to the monthly invoicing from which the pharmacies’ margin is calculated, the amount by which it exceeds 78.34 Euros, calculated in terms of the public sale price VAT inclusive. This new monthly invoicing criteria will be applicable to invoices issued after January 31, 2004. Royal Decree 1328/2003 shall come into force on 1 January 2004. Anatomical classification of medicines: ATC classification systemRoyal Decree 1348/2003, of October 31, has approved the adaptation of the anatomical classification of medicines to the Anatomical Therapeutic Chemical classification system (ATC). The adaptation to the ATC classification system entails the modification of the corresponding Annexes of Royal Decree 83/1993, of January 22 and its implementing Order and Royal Decree 1663/1998, of July 24, and of the public financing of the medicinal products specified by the Royal Decree. Likewise, it involves the updating of the therapeutic groups and subgroups of medicines excluded from the public financing, as well as the therapeutic groups and subgroups of reduced contribution, both listed in the Royal Decree. Finally, it updates (i) the therapeutic groups or medicinal products which can be prescribed from one to four containers in the official prescriptions used for the pharmaceutical allowance of the National Health Service; as well as (ii) the therapeutic groups and subgroups that cannot be substituted by the pharmacist without the express authorisation of the prescribing doctor. Use of the health card to access the pharmaceutical allowance in GaliciaAccording to Galician Decree 30/2003, of October 2, in order to obtain the pharmaceutical allowance controlled by the Health Service of Galicia, it is necessary to show the health card in the establishments authorised for the prescription and dispensation of medicines. As an exception, in cases of emergency (which will appear in the official prescription), showing said health card will not be necessary. Meanwhile National Health System users from other autonomous regions will identify themselves with the document that proves their right to sanitary care. This Galician Decree shall enter into force on 15 January 2004. Principles and guidelines for good manufacturing practice in respect of medicinal products for human useDirective 2003/94/EC lays down the principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products. These principles and guidelines refer to good manufacturing practice in relation to quality management, personnel, premises and equipment, documentation, production, quality control, sub-contracting, complaints, the system in place for recalling products, and self-inspection obligations. (More information) Council Conclusions on reinforcing the competitiveness of the European-based pharmaceutical industryThe European Council has published its Conclusions on reinforcing the competitiveness of the European-based pharmaceutical industry, issued according to the report of the G-10 High Level Group on innovation and the provision of medicines in its Communication on “A stronger European-based pharmaceutical industry for the benefit of the patient”. (More information) Marketing authorisation of the reference medicinal product under the abridged procedureThe European Court of Justice addresses two preliminary rulings concerning the interpretation of one of the requirements for the granting of a marketing authorisation for a generic medicinal product under the abridged procedure, in particular, the requirement that the medicinal product is essentially similar to a product which has been authorised within the Community and marketed in the Community for a determined period of time prior to the said application. (More information) Other legislative news regarding pharmaceutical mattersRoyal Decree 1277/2003, of October 10, that establishes the general rules for the authorisation of centres, services and health establishments. Order of the Ministry for Health of the Balearic Islands, of 26 September 2003, that creates the Commission for the controlled use of medicines. FOOD LAWFood SupplementsThe Spanish Government has issued rules regarding the so-called “food supplements”. (More information) Authorisation, traceability and labelling of genetically modified food and feedThe European Union has adopted new legislation on the authorisation, labelling and traceability of food and feed containing GMO’s. (More information) Unjustified obstacles to trade of enriched foodstuffsThe Court of Justice analyses the consistency with Community law of a Danish administrative practice of not allowing foodstuffs enriched with vitamins to be marketed in Denmark unless a nutritional need for the enrichment has been documented in Denmark. (More information) Date of reference in nutrition labelling for foodstuffsThe Court of Justice addresses a preliminary ruling referred by an Austrian court, regarding whether the indications of nutritional values declared in the nutrition labelling of foodstuffs may refer to the end of the product’s minimum conservation period. 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Act 32/2003, of November 3, the General Telecommunications Act (BOE, 4 November 2003)
The GTA incorporates into Spanish internal law the so-called “Telecom Directives package” approved at Community level in 2002 in order to move forward the process of liberalisation of the telecommunications market.
We would highlight the following elements of the GTA in particular
(i) Scope: the GTA regulates telecommunications, a term that includes the operating of networks and the provision of electronic communications services and associated resources. Outside its scope are audiovisual contents, the basic mass media system of an audiovisual nature, and the services of the Information Society (IS).
(ii) Authorisation Methods: the traditional authorisation methods (individual licences and general authorisations) are abolished. Therefore, the operators interested in running networks or rendering electronic communications services will only have to present prior, irrefutable notification to the CMT (within the terms of the statute) and comply with the conditions laid down for the exercise of their activity.
(iii) Relevant markets: the relevant product markets and geographical markets (wholesale and retail) will be determined by the CMT, in accordance with the Guidelines of the European Commission for Market Analysis and the Recommendation on Relevant Markets. Consequently, the four traditional relevant markets established by the Interconnection Regulation disappear and will be replaced by those determined by the CMT from amongst those established by the said Recommendation. The CMT will have to prepare, every two years and following a report of the Service for the Protection of Competition, an analysis of the relevant markets.
(iv) Operators with significant market power: the GTA adopts the typical concept of Competition Law and, therefore, market share disappears as the main criterion for determining the existence of a dominant position in the relevant market. In this sense, an operator with significant market power is one that, individually or jointly with others, enjoys a position that allows it to act within the market independently of its competitors, customers or even the consumers themselves. The CMT will be in charge of declaring which operators have significant power within each of the relevant markets and in connected markets, if the CMT verifies that the power of an operator in a particular market is such that it has repercussions in a connected market.
(v) Imposition of ex-ante statutory obligations: the GTA introduces a more flexible system in the imposition of these types of obligations, so that they will only be imposed by the CMT in those relevant markets in which, due to the existence of operators with significant market power, no effective competition exists. These obligations will preferably be imposed in matters which do not restrict free competition greatly, such as access, interconnection, selection and pre-selection. In those markets in which the CMT verifies that effective competition exists, the obligations imposed on those operators previously declared as having significant market power, will have to be abolished.
(vi) Access and Interconnection: the GTA adopts the concepts of the Community rules themselves, and stipulates expressly that interconnection is a particular type of access. Access is defined as the act of making resources or services available to another operator for the purposes of providing electronic communications services, and is not, therefore limited to access to networks. Interconnection is defined as the physical and logical linking of networks of public communications used by one or several operators in such a way that it guarantees the “inter-operability” of services.
The GTA maintains the obligation and the right of authorised operators of public networks of electronic communications to permit and obtain the interconnection of those networks and the voluntary nature of the agreements of interconnection and access. It also maintains the power of the CMT to intervene in any conflicts that arise between operators as a result of these matters and to impose upon them, whenever necessary, obligations ensuring the proper operation of networks.
(vii) National Regulation Authorities: the Law establishes that not only the CMT and the Ministry of Science and Technology (“MST”) will be considered NRAs, but also the Government, the superior and managing bodies of the Ministry of Economy (in matters of price-regulation) and the as yet non-existent State Radio-communications Agency (“SRA”).
The GTA maintains the responsibilities hitherto assigned to the CMT and the MST via the Secretary of State for Telecommunications and the Information Society (“SSTIS”), with the exception of control over compliance with public service obligations. This control is now legally conferred on the MST, and without prejudice to the powers conferred on the CMT in matters of Universal Service.
As regards the SRA, it is created as an autonomous body with its own legal personality, with full capacity to act, and assigned to the MST via the SSTIS. Its object is the management of the radio-electric spectrum and its most important functions are: (a) the planning proposals and management of the said spectrum; (b) the procedure and granting of the telecommunications authorisations needed for its use, except when their number is limited, in which case this power will correspond to the MST; (c) the authorization and inspection of radio-electric facilities with regard to authorised levels of transmission; (d) the checking of the technology of radio-electric transmissions for the identification, localization, and elimination of harmful interference; and (e) the management over a voluntary period of the spectrum user fee.
(viii) Radio-electric spectrum: the spectrum is recognised for first time as belonging to the public domain, whose ownership, management, planning, administration and control is governed by the State. The GTA maintains as the governing principle of its management, its efficient use by those authorised to use it. It also maintains the existing system of authorisation (i.e. assignment or administrative authorization, depending on the use).
The GTA also introduces the possibility for operators that obtain specific rights of exclusive use of the spectrum, to broadcast it, following administrative authorisation and according to the terms and conditions established by statute. In no case is the assigning owner exempted from the obligations assumed vis-à-vis the Administration or from those established in the National Chart of Attribution of Frequencies (“Cuadro nacional de Atribución de Frecuencias”).
(ix) Obligations of Public Service and Universal Service: the general nature of the system currently in force is maintained, confirming the extension of Universal Service to include Internet access, such extension already being established in the Information Society Services Act. Additionally, Telefónica de España, S.A.U. remains obliged to provide Universal Service until, at least, the approval of the regulations that replace the Regulations of Universal Service currently in force.
(x) Rights of the operators to occupy the public domain: the GTA maintains the recognition of the right ex lege of operators to occupy the public domain as far as is necessary for the establishment of networks of electronic communications. However, in order to avoid that the public authorities hinder the exercise of this right, they must adhere to a procedure and certain special requirements when seeking to influence the said exercise, based on reasons of public health, public security, national defence, protection of the environment and urban or territorial planning. Likewise, the Act provides for the creation of a body of cooperation between the different public Administrations concerned in the development of networks, with the objective of promoting their construction.
(xi) Penalty system. Coercive fines: in order to counteract the relaxation of the mechanisms controlling the provision of services and the development of networks, the penalty system is made considerably harsher. In this sense, particularly relevant is the introduction of a system of coercive fines which confers upon the CMT the power to impose fines of between 100 and 10,000 euros daily for as long as the infringement persists, without prejudice to the relevant penalties that may be imposed for the said infringements.
(xii) Liberalization of broadcasting by radio and by cable television: the need to obtain administrative concessions for the provision of these services is abolished, so they will be able to be provided in a system of free competition subject to the obtaining of administrative authorisation, according to statutory conditions.
(xiii) Transitional system: the transitional system will last until the approval of the Regulations developed by the GTA. Until then, the provisions contained in the Regulations and the other provisions for development of the Act currently in force, will continue to apply, to the extent that they do not run contrary to it. Of particular relevance are the following transitional provisions:
§ the ownership rights granted under the previous legislation (i.e. individual licences, general authorisations and assignments that are still pending transformation) will be extinguished automatically, and their owners will be able to continue carrying out their activities in the way in which they were doing so previously. The extinguishment of these ownership rights will not lead to the extinguishment of linked rights, such as those that confer rights of use of the spectrum, of numbering, or of occupation of the public domain or private property;
§ the concessions granted for private use of the spectrum will remain in force in their current terms until the new Regulations of the spectrum are approved; and
§ until December 31, 2009, new administrative authorisations for the provision of services of broadcasting by radio and cable television will not be granted, unless the Government, from December 31, 2005, and following a report of the CMT, considers it appropriate. Despite this, once the Regulations governing services of broadcasting by radio and cable television have come into force, new administrative authorisations will be capable of being granted in the territorial areas in which the relevant authorisations were not granted under the Telecommunications by Cable Act.
(xiv) Repealed regulations: the GTA repeals, amongst others, the GTA hitherto in force (except for certain additional and transitional provisions), the precepts that remained in force of the Telecommunications by Cable Act, the Liberalisation of Telecommunications Act, Act 17/1997, and all those provisions of equal or lower rank which run contrary to the GTA.
Report of the Delegate Commission for Economic Affairs (“CNE”) of 18 September 2003
The CNE, answering an enquiry of the Telecommunications Market Commission (“CMT”) and after analysing the possible effects of the implementation of the PLC technology in the power network, has declared itself to be in favour of the provision of broadband telecommunications services via PLC technology. We would highlight the following elements in particular:
(i) PLC technology is a piece of telecommunication technology that permits broadband Internet access using the power network as hardware. This technology allows installation costs to be saved, since it uses an infrastructure already deployed in the whole territory. Likewise, it allows for high-speed access.
(ii) Given that its installation may mean that the suitable levels of electromagnetic compatibility for the correct provision of power are exceeded, the CNE recommended to the CMT the extension of the conditions demanded of the operators authorised to provide broadband telecommunications services via PLC technology. The said operators were thus obliged to adopt measures to limit electromagnetic radiation and to avoid problems of quality in the power service.
(iii) Given that the services provided via the electrical network are telecommunications services, the operators authorised to provide these services will be subject to the regulations of both the telecommunications and electricity sectors.
(iv) As regards the electricity sector, the law requires the obtaining of authorisation from the CNE for the use of electrical networks for the provision of telecommunications services and, in any case, the electrical company will have to continue complying with all the obligations established in the legislation pertaining to the electricity sector.
(v) The company carrying out the PLC activity, which will be the operator authorised to provide telecommunications services, must be legally separated from the company authorised to carry out the distribution and transportation of electricity activities, for the purposes of which both companies must establish between themselves an assignment contract for use of the electricity networks.
Administrative Rule 2/2003, of September 26, of the CMT, on the proceeding for the supply of clients’ data in order to provide directory services under a competition regime (BOE, 15 October 2003)
This Rule governs certain basic aspects of the providing of directory services under a competition regime, such as, among others
(i) the obligation to provide information about their clients to the operators that provide the telephony service at the disposal of the public by means of allocating numbers to them;
(ii) the entities that have the right to receive such information (e.g. among others, those able to provide a consulting service, those that elaborate telephone directories included in the scope of the universal service and those providing the urgent call service);
(iii) the way in which the requests and the supply of information shall be made;
(iv) the conditions that must be complied with in order to beneficiate of the requested information; and
(v) the creation of a data management system for the clients in the CMT for an efficient management of the information.
Ministerial Order PRE/3028/2003, of October 30, of the Ministry of the Presidency, which provides the publishing of the Agreement of the Delegate Commission for Economic Affairs approving the price liberalisation of the retail ADSL services of Telefónica de España, S.A.U (BOE, November 1, 2003).
The Delegate Commission for Economic Affairs approved on last September 25, 2003 the price liberalisation of the retail ADSL services of Telefónica de España in order to give access to the retail broadband. Consequently, the prices of the retail ADSL services will no more be subject to the prior administrative authorization and shall only be communicated to the Ministries of Economy and of Science and Technology, so as to the CMT and the Council of Consumers and Users.
First Final Disposition of the Act 32/2003 of November 3, General Telecommunications Act
The First Final Disposition of the new GTA modifies certain precepts of the Law on Information Society Services and Electronic Commerce, especially with regard to commercial communications sent by e-mail, SMS or any other equivalent forms of electronic communication (“spamming”). This modification incorporates into our legal system the provisions of the Directive 2002/58/CE concerning the processing of personal data and the protection of privacy in the electronic communications sector.
We would highlight the following from the changes introduced:
(i) The Law introduces a new exception to the general rule requiring the express consent of the addressee for the sending of non-solicited commercial communications by e-mail, SMS or any other equivalent forms of electronic communication. Thus, sending is allowed provided that: (a) a previous contractual relationship exists between the data subject and the company sending the communication; (b) the data have been obtained in a legal way; (c) the communications concern products or services of the company itself and are similar to those that were initially contracted; and (d) the data subject is guaranteed of his right of opposing data-processing for promotional purposes, by means of a simple and free process, both at the moment of the collection of the data and in the commercial communications sent to him by the provider.
(ii) The information society service providers who use systems of data storage and retrieval in individual terminals (e.g., “cookies”) are obliged to inform the addressees, clearly and completely, of the use of such devices and their purpose, and must also offer them the possibility of rejecting such usage by means of a simple and free process. Exceptionally, data access and storage is allowed in the following cases: (i) in order to carry out or facilitate the electronic transmission of the message; or (ii) when it is strictly necessary for the provision of information society service expressly requested by the addressee.
(iii) The classification of some infringements is modified in order to adapt such classification to the new regulation of electronic communications.
(iv) Sanctioning power is conferred on the Data Protection Agency in relation to certain infringements regarding electronic communications.
(v) The amendment facilitates the development of the Information Society and the convergence with Europe by means of the presentation by the Ministry of Science and Technology to the Government - for its approval - and to Parliament, of a four-year plan with measurable targets based on specific actions.
Decision of the Provincial Court of Barcelona (Section 15), of 28 May 2003
The origin of the conflict was the publication by a magazine of a sex oriented report in which the model was identified with a well known videogame character (Lara Croft). The model appeared in said issue naked or half naked, disguised as the latter character, next to images of Lara Croft that had been previously modified so that she also appeared naked or half naked.
The company that created the videogame that, on the other hand, is targeted to a teenager public, sued the magazine on the grounds of a breach of its moral and economic author’s rights on the character.
Firstly, the Court points out that the main character of the videogame is copyright subject matter, being an original creation. In this context, the use of the work in the described form giving a “sexual image” of the character without any respect of its integrity and in breach of the legitimate interests of the rights holder means an infraction of its moral rights, so as a breach of its economic rights as the work is reproduced, communicated to the public and transformed.
In order to justify its conduct, the magazine claimed basically the confluence of two limits to copyright: (i) those related to parodies and (ii) the use of works in information grounds. With regard to the first limit, the Court sets forth that it is not the case as the issue lacked any critical aim in the use of the work, pointing out that said limit shall be used in a restrictive manner. With regard to the second limit, the Court holds that is it not the case either, as the use of the work did not have any aim to inform.
With respect to the compensation for the arising moral and economic damages, the Court clearly distinguishes them, and condemns the magazine to pay for both. The economic damages are quantified on the basis of the fees that would have been earned by the holder of the copyright in the case it had authorized the exploitation of the work. With respect to moral damages the Court holds that they are automatically produced once the facts that originate them are proved. Thus, the Court endorses the applicant’s demand for a ten million pesetas compensation (around 60,000 €).
Order 2958/2003, of the Ministry of Health and Consumption, of 23 October 2003, which establishes the new groups of medicinal products and approves the corresponding reference prices (BOE, 25 October 2003)
This Order of the Ministry of Health and Consumption (the “Order”) implements the new reference price system, introduced after the modification of Article 94.6 of the Medicines Act, and stipulates, inter alia:
(a) It establishes the new groups of medicinal products, formed by all those financed products that contain the same active substance, which must include, at least, one generic product (Annex I). Expressly excluded from these groups are: (i) innovative medicinal formats (i.e., those described as such by the Director of the Spanish Agency of Medicines and Health Products); and (ii) those products specified for paediatric treatments or those for which there exists a significantly different dosage for a specific indication (which will form independent groups).
(b) It approves the reference prices of the groups. As regards the parameters used for the calculation of such prices, the Order states that the three products for medicinal products used in the said calculation must belong, whenever possible, to three different company groups. Also, the Order intends to give a response to the legislative mandate directed at ensuring the market supply of the products used in the aforementioned calculation, stating that those products shall not have an ex-factory price lower than 2 Euros, and that neither, in any circumstances, shall the resulting reference price be lower than this amount.
(c) The substitution regime of the prescribed product stipulates, in the terms of Article 94.6 of the Medicines Act, that the product be substituted whenever its price is higher than the reference-price of its group, by the lowest-priced generic product. If this generic medicine does not exist, the prescribed product shall be dispensed at the reference-price.
(d) The dispensation procedure, in the cases where no branded product is prescribed works similarly. In such cases, the pharmacist must dispense the lowest-priced generic product and, if the said generic product does not exist, a branded product that adjusts to the prescription, at the reference price.
Annex III of the Order lists the lowest-priced generic medicinal products that shall be used for substitution and dispensation in the above referred cases (c) and (d).
Per the Order, generic medicinal products which have a higher price than the reference price shall reduce their ex factory price to the said reference price. Non-generic medicinal products whose price is higher than the reference price may voluntarily reduce their ex factory price to the reference price.
Finally, the Order regulates the procedure for the payment by the manufacturers to the wholesales or to the pharmacies of the difference between the ex factory price or, as the case may be, the wholesale price, and the reference-price, which shall apply if the interested parties do not reach an agreement.
Commission Directive 2003/94/EC of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and medicinal products used in research pertaining to human use (Official Journal L 262, of 14 October 2003)
This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products for human use whose manufacture requires the relevant authorisation. Likewise, medicinal products imported from third countries are required to have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down by this Directive.
According to the Directive, it is the manufacturer’s responsibility to ensure that manufacturing operations are carried out in accordance with good manufacturing practice, the manufacturing authorisation and the information provided in the application for marketing authorisation, either by the applicant or the sponsor, as accepted by the competent authorities, and to establish and implement an effective pharmaceutical quality assurance system. To this end, the manufacturer has several obligations relating to the personnel at his disposal to achieve the pharmaceutical quality assurance objective, to the manufacturing premises and equipment, as well as to the manufacturing operations.
Manufacturers shall also maintain a specific documentation system which shall enable the history of the manufacture of each batch and the changes introduced during the development of an investigational medicinal product to be traced. This documentation shall be retained for a period of between one and five years, depending on the case, the sponsor or the marketing authorisation holder, if different, being responsible.
Also established is the obligation to establish and maintain a quality control system, placed under the authority of a person who is independent of production. Samples of each batch of finished medicinal product shall be retained for at least one year after the expiry date, or two years after completion or formal discontinuation of the last clinical trial in which the batch was used, respectively. These obligations are complemented by the necessary implementation of a system for recording and reviewing complaints, together with an effective system for recalling of (investigational) medicinal products in the distribution network.
Directive 2003/94/EC repeals the previous Commission Directive 91/356/EEC, of June 13. It shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union, and Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 2004 at the latest.
Council Conclusions of 22 September 2003 on reinforcing the competitiveness of the European-based pharmaceutical industry (Official Journal C 250, 18/10/2003)
The Council recognizes that the European-based pharmaceutical industry plays a vital role in both the industrial and health sectors, as well as in the science base.
The Council welcomes the response given by the Commission to the report of the G10 High Level Group on innovation and the provision of medicines, inviting Member States to consider the Commission's suggested implementing actions for (i) competition concerning authorised medicines that are neither purchased nor reimbursed by the State; and (ii) the rapid launch of medicines on the market after granting a marketing authorisation.
In addition, the Council invites the Commission to report periodically on the state of competitiveness of the pharmaceutical sector, and to organise an EU-wide reflection together with all interested Member States and stakeholders on different approaches to pricing and reimbursement of medicinal products, exploring the scope of more competitive and dynamic market mechanisms, aimed at ensuring the equitable and rapid access of patients throughout the EU to medicines.
Judgement of the Court of Justice of the European Communities of 16 October 2003, Case C-223/01, AstraZeneca A/S vs Laegemiddelstyrelsen, participating Generics (UK) Ltd.
The Court of Justice of the European Communities addresses two preliminary rulings concerning the requirements for the granting of a marketing authorisation for a generic medicinal product under the abridged procedure, in particular, the requirement that the medicinal product is essentially similar to a product which has been authorised within the Community and marketed in the Community for a determined period of time prior to the said application.
In this context, the Court rules that the requirement for the reference product to have been marketed in a Member State shall be fulfilled if the reference medicinal product has been granted a marketing authorisation, regardless of whether it has been effectively marketed.
Additionally, the Court considers that in order for an application for marketing authorisation of a generic medicinal product to be dealt with by way of the abridged procedure, it is necessary and sufficient that the marketing authorisation of the reference medicinal product be in force in the Member State concerned on the date of that application.
Royal Decree 1275/2003, of 10 October 2002, on food supplements (BOE, 14 October 2003)
This Royal Decree incorporates Directive 2002/46/CE, of 10 July 2002, on food supplements, into the national legal system. The new regulation applies to all foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, setting out the requirements of their composition and labelling. These products may only be referred to as “food supplements” (complementos alimenticios) and may only be commercialized pre-packaged and in dose form.
This Royal Decree sets out the requirements applicable to the labelling, presentation and advertising of food supplements, that must not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients or attribute to such products properties of preventing, treating or curing human diseases.
Operators responsible for the production, transformation, packaging, storage, distribution, import or marketing of food supplements shall be registered with the General Health Food Registry, and notify the competent authority of the product’s placing on the market by forwarding it a model of the label used for the product.
Additionally, the Royal Decree sets out a comprehensive numerus clausus inventory of the vitamins and minerals which may be used in the manufacture of food supplements, and the recommended daily doses of such nutrients, that shall also be indicated on the labelling. No rules are established, however, for substances other than vitamins and minerals. Royal Decree 1275/2003 provides that the national restrictions or prohibitions shall remain in force with respect to food supplements which include such other substances.
Regulation (EC) No 1829/2003 of the European Parliament and of the Council, of 22 September 2003, on genetically modified food and feed (Official Journal L 268, of 18 October 2003)
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003, concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (Official Journal L 268, of 18 October 2003)
The joint approval of Regulation (EC) and Regulation (EC) involves a thorough review of the Community regulations applicable to genetically modified organisms (GMO) and the foods and feed which contain GMO.
Regulation 1829/2003 revises and unifies the authorisation procedures applicable to GMOs. In particular, it amends the procedure established in Regulation 258/97, of the European Parliament and of the Council, concerning novel foods and novel food ingredients, and makes it more transparent. Regarding novel foods substantially equivalent to existing foods, the obligation to notify their placing on the market is replaced, with respect to genetically modified foods, by a prior authorisation requirement. Feeds produced from GMO, for which no authorisation procedure existed, shall also be to the authorisation procedure set out in the Directives on the deliberate release into the environment of genetically modified organisms. Thus, all Community procedures on feeds that contain or are produced from GMO are hereby unified.
Measures regarding labelling are stricter in the new regulation. The obligation to inform in an objective way that a food or feed contains or is produced from GMO has a global scope, irrespective of the detectability of DNA resulting from the genetic modification in the final product. This measure aims at granting consumers the possibility of making an informed choice and precluding potential misleading. Hence, in the case of pre-packaged products, the labelling must contain the words “genetically modified” (modificado genéticamente) and, among others, mention any characteristic or property that causes the food to differ from its conventional counterpart in composition; nutritional value, intended use, implications for the health; or may give rise to ethical or religious concerns.
However, a threshold is established for the adventitious or technically unavoidable presence of genetically modified material in foods or feed (0,9%), in order for operators that avoid using GMO not to be subject to the labelling requirements set out in this regulation. In any event, operators must be in a position to demonstrate to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.
Finally, Regulation 1829/2003 contains a command for the European Commission to establish and maintain a Community register of genetically modified food and feed, which shall be made available to the public.
Regulation 1830/2003 refers, in essence, to the operators’ obligations with respect to GMO traceability, in order to facilitate the accurate labelling of such products in accordance with the requirements of Regulation 1829/2003, and the withdrawal of products with unforeseen adverse effects on human health, animal health, or the environment.
At each stage of their placing on the market of products that contain or are produced from GMO, including bulk quantities, operators must ensure that the information that the product contains or is produced from GMO is transmitted in writing to the operator receiving the product. The Regulation also foresees the establishment by the Commission of systems for the development and assignment of unique identifiers for GMO.
The new regulations allow products comprised within their scope of application that were being legally commercialised within the Community prior to their entry into force to continue to be commercialized, for certain periods of time and subject to certain conditions.
Judgement of the European Court of Justice, of 23 September 2003, Case C-192/01, Commission of the European Communities vs. Kingdom of Denmark
The Court of Justice addresses an action brought by the Commission against an administrative practice applied in Denmark, previously denounced by an economic operator before the Commission, because of obstacles to the marketing of a foodstuff lawfully marketed in other Member States.
Under Danish national legislation, the use of substances intended to be added to foods in order to modify, inter alia, their nutritional value, shall be authorised by the Minister for Food. This system is characterised by the existence of an administrative practice as a consequence of which additives such as vitamins and minerals may be marketed in Denmark only if it is evidenced that there is a nutritional need for those elements in the Danish population. Thus, outside certain defined cases of what is considered to be a nutritional need, the marketing of all foodstuffs to which vitamins and minerals have been added is systematically prohibited, without distinguishing according to the different vitamins and minerals added or according to the level of risk which their addition may possibly pose to public health.
The Court of Justice understands that such administrative practice a measure having equivalent effect to quantitative restrictions within the meaning of Article 28 EC. As regards whether such practice may be justified under Article 30 EC (that is, for reasons of public health) the Court finds that the absence of a nutritional need of the population of a Member State cannot, by itself, justify a total prohibition of the marketing of foodstuffs lawfully manufactured and/or marketed in other Member States. A decision to prohibit marketing can only be adopted if the real risk alleged for public health appears sufficiently established. Thus, the systematic nature of the marketing prohibition resulting from the Danish administrative practice is contrary to Community law, which requires a detailed assessment, case-by-case, of the effects which the addition of the minerals and vitamins in question could entail.
Judgment of the European Court of Justice (Sixth Chamber) of 23 October 2003, Case C-40/02, Margareta Scherndl v Bezirkshauptmannschaft Korneuburg
The Court of Justice refers to a preliminary ruling on the interpretation of Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs.
The questions were raised in an administrative penal proceeding, finding an Austrian operator guilty of breaching the Austrian regulations on nutrition labelling of foodstuffs, due to a difference between the declared values of vitamin C and those established in the course of official checks.
The operator found that labelling stating values for the date of purchase or consumption was not possible where the foodstuff in question had a long conservation period and, therefore, indications of nutritional values could refer to any point in time between the sale to the final consumer and the expiry of the conservation period. In view of the fact that the vitamin content could diminish substantially over time, and that there were no objections to an overdose, the values stated referred to the end of the minimum conservation period.
One of the questions referred to the Court for a preliminary ruling refers to the definition of “average value” contained in the above mentioned Directive, that is, the value which best represents the amount of the nutrient which a given food contains. In accordance with Article 6.8 of the Directive, values declared in nutrition labelling shall be average values. No provision of this Directive specifies the reference date to be taken into consideration for determining such average value, and no regulations have been issued for implementing the Directive.
The Court addresses the question having regard to other provisions of Community law, in particular, Directive 2000/13/EC of the European Parliament and of the Council relating to the labelling, presentation and advertising of foodstuffs, that defines the date of minimum durability of a foodstuff' as the date `until which the foodstuff retains its specific properties when properly stored'. On this basis, the Court finds that the value of a nutrient which is indicated on a foodstuff may correspond to the value of that nutrient in the foodstuff in question at the end of its minimum conservation period.