Spain. Medicinal Products
1. Is the problem of counterfeit medicinal products identified in your jurisdiction? What is the amount of falsified medicinal products on the market?
The problem of counterfeit medicinal products is clearly identified in Spain as an important, and increasing, public health problem. In 2008, the Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios – “AEMPS”) issued a Strategy Paper on Counterfeit Medicinal Products for the period 2008-2011 (Estrategia frente a Medicamentos Falsificados 2008-2011). The strategy was based on five pillars: (i) cooperation among all stakeholders, both public institutions and private entities, in the healthcare sector and in other areas (tax, border control, security forces, etc.); (ii) implementing quick, efficient information mechanisms among these stakeholders, as well as with the health authorities of other countries and other international organisms; (iii) reinforcing education and raising awareness of the authorities, civil servants, private entities, and citizens. In 2012, a new Strategy Paper on Counterfeit Medicinal Products was issued for the period 2012-2015 (Estrategia frente a Medicamentos Falsificados 2012-2015). It maintains the general principles of the prior strategy, and adapts them in following the experience gained and the approval of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. There are no reliable figures on the amount of counterfeit products on the market, but it is estimated that roughly 1% to 3% of the medicines purchased in Spain could be counterfeit, and Spain ranks as the fourth country in Europe in terms of volume of falsified medicines on the market. So far, however, no cases have been detected in the legal supply chain, where surveillance and control measures are reportedly proving effective. Falsified medicinal products reach patients through illegal means, mainly, via the Internet and, less frequently, through illegal establishments such as gyms or herbalists.
2. Have there recently been any cases related to counterfeit medicinal products?
No cases of counterfeit medicinal products have been reported in the legal supply chain, in spite of the fact that during the period 2008-2011 over a hundred inspections of wholesale distributors of medicines were performed, which included a review of the areas of risk concerning counterfeit products. However, in view of cases that took place in neighboring countries, this issue remains a priority with the health authorities. On the other hand, the presence of counterfeit medicines has increased in illegal supply chains. The Spanish security forces have carried out several operations against manufacturers and importers of falsified medicines, both individually and in cooperation with Interpol, Europol and national agencies in other countries. Also, in the past few years, over 300 websites have been investigated, and measures taken to close or ban access to those which illegally sell medicines (including counterfeit medicines) over the internet.
3. Is activity related to counterfeiting a medicinal product a crime? Please state which criminal law provisions may be potentially used against entities engaged in such activity.
Yes. Counterfeiting medicines is recognized as a crime under the Spanish Criminal Code, provided, however, that the activity poses a risk to the life of health of individuals. In particular, article 362 of the Spanish Criminal Code recognizes the following as criminal offences: (i) the alteration of quantities, doses of composition of medicines, thereby depriving them totally or partially of therapeutic efficacy; (ii) the imitation or simulation of medicines with the aim to place them on the market or use them in any way; and (iii) the deposit, advertising, offer, exhibition, sale, provision for use of medicines by those who know of their alteration or falsehood; provided, in all cases, that this poses a risk to the life of health of individuals. These crimes may be penalized with a sentence from six months up to a maximum of three years imprisonment, and with fines ranging from six to eighteen months; and one to three years special disqualification from practicing the profession related to the offence committed (or three to six years if the crime is committed by pharmacists or technical directors of authorized laboratories). Please note the day-fine system consists of an financial penalty from a minimum of 2 EUR to a maximum of 400 EUR, established according to the nature of the infringement and the financial situation of the convicted party. These penalties may be increased by one degree (i.e. by taking the maximum duration of the penalty as its minimum duration, and increasing the maximum duration by 50%) if aggravated circumstances concur. It is of note that the legal entity itself could not be pursued criminally for this type of offence, but rather the individuals personally responsible for the offence, including, where applicable, the (legal or de facto) managers of the entity. On the other hand, the counterfeiting of medicines (even if no risk to health is caused) constitutes a very severe administrative infringement under article 100.2.c).2 of Spanish Law 29/2006, on the Guarantees and Rational Use of Medicines and Medical Devices (the “Spanish Medicines Act”), which may be punished with fines ranging from 90,000 EUR to 1,000,000 EUR. The fines which may be imposed under administrative regulations, if the infringement is qualified as an administrative (i.e. not criminal) offence, are paradoxically, potentially much higher than those that may be imposed under the Criminal Code if the action qualifies as a crime.
4. Is there a definition of a falsified medicinal product in your jurisdiction?
As of this date, falsified medicinal products are not defined by any piece of Spanish legislation. The AEMPS position papers recognize the definition provided by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.
5. Please advise on regulations in place to ensure safety of medicinal products and to prevent falsification of medicinal products. Who is authorized to enforce relevant laws?
Generally, under the Spanish Medicines Act and complementary regulations, medicinal products may only be sold or purchased, or physically handled, by duly authorized entities: ? - Manufacturers of medicines must be in possession of an authorization as a pharmaceutical laboratory (“laboratorio farmacéutico”) granted under Royal Decree 824/2010, of 25 June, governing pharmaceutical laboratories, manufactures of active principles for pharmaceutical use, and the external trade of medicines and investigational medicines. This obligation also applies to importers of medicines, who are generally responsible for the compliance of the imported products and for guaranteeing that each imported batch is subject, in Spain, to the pertinent qualitative and quantitative controls to guarantee that they fulfill the terms of the marketing authorization. ? - Distribution of medicines may only be performed by pharmaceutical wholesalers holding the pertinent distribution authorization granted under Royal Decree 2259/1994, of 25 November, governing pharmaceutical wholesalers and wholesale distribution of human medicines and pharmaceutical products. ? - According to article 2.6. of the Spanish Medicines Act, the custody, conservation and dispensation of human medicines corresponds exclusively to legally authorized pharmacies open to the public, and to the pharmacy departments of hospitals and healthcare institutions. Wholesalers, pharmacies and hospitals are bound to purchase medicines only from authorized pharmaceutical laboratories (manufacturers or importers) or from wholesalers, and all entities in the supply chain are bound to supply the medicines to entities duly authorized to purchase and handle them. For these purposes, the AEMPS makes available, through its website, the lists of authorized pharmaceutical laboratories (Registro de Laboratorios Farmacéuticos - https://labofar.aemps.es/labofar/registroFarmaceutico/consulta.do?metodo=detalleBusqueda) and of authorized wholesalers (Catálogo de Almacenes Mayoristas - https://sinaem.agemed.es/AlmacenesMayoristas). Wholesalers are also bound to keep counterfeit medicines which are detected in the distribution channel separate from the remaining medicines, label them as not fit for sale, and immediately inform the competent authorities as well as the marketing authorization holder of the product. Both pharmaceutical companies and wholesalers are subject to periodical inspections by the health authorities. Among the aspects covered by such inspections are precisely the areas of risk concerning counterfeit, following a specific questionnaire. The procedure has already been applied in over 100 inspections carried out by the health authorities on pharmaceutical distributors. Purchasing medicines from, or making them available to, entities who are not in possession of the relevant authorization constitutes a severe infringement under Article 100.2.b).17 of the Spanish Medicines Act, which may be punished with fine
6. Please advise regarding existing boarder measures (and related legal provisions) allowing regulatory authorities and right holders to fight against counterfeited medicinal products and about the efficiency of such measures.
Regulations on border controls of medicines have been recently updated. Currently, the procedure is regulated by Order 2136/2011 of the Ministry of Health, of 19 June 2011, which establishes the form of the border health controls carried out by the pharmaceutical inspection service and regulates the Computerized System of Pharmaceutical Inspection for External Health (Orden SPI/2136/2011, de 19 de julio, por la que se fijan las modalidades de control sanitario en frontera por la inspección farmacéutica y se regula el Sistema Informático de Inspección Farmacéutica de Sanidad Exterior – the “Order”). The Order is applicable to medicines, including bulk drugs, raw materials destined for the manufacture of medicines, medical devices, cosmetics, biocides, etc. It is established that these products shall be subject to systematic border controls. There are three different levels of controls: (i) documentary controls: analysis of certificates and other relevant documentation accompanying the products: (ii) identity controls: visual inspection of the correspondence between the products and the certificates, and the presence of the signs and marks that must accompany the products in accordance with EU and national regulations, including the inspection of the labeling; (iii) physical controls: controls of the product itself, its labeling, packaging, instructions for use, storage conditions, etc. This control may include the analysis of samples. All products subject to the Order shall be systematically subject to the first level of controls (documentary controls). The frequency of identity and physical controls shall be determined based on the potential risk in relation to the products, and in coordination with the AEMPS. The main criteria for establishing the level of necessary controls are based in the country of origin of the deliveries and the experience gained in recent years. The AEMPS has, in recent years, organized several training sessions addressed for the border inspections, and has granted them online access to all relevant information (authorized medicines, authorized pharmaceutical laboratories and wholesalers) and also put in place a rapid information exchange system with the border control authorities. The main tools to fight against counterfeited medicinal products, both for the regulatory authorities and for the rights holders, are those set out in 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, and its implementing regulations. In Spain, this Regulation has been implemented by Order 2343/2006 of the Ministry of Economy and Treasury, of 3 July 2006, regarding the intervention of border authorities in the event of reported goods suspected of infringing intellectual property rights (Orden EHA/2343/2006, de 3 de julio)
7. Are there any regulations allowing manufacturers, distributors or marketing authorization holders to eliminate falsified products from the market? Are there any other legal measures competitors, manufacturers, distributors or marketing authorization holders could take?
Any participant in the supply chain who detects the presence of falsified medicines in his possession must immobilize them, keep the separate from legal medicines, label them as not fit for sale, and immediately report the issue to the health authorities and to the marketing authorization holder so that they may take the appropriate measures. The holder of the goods may only submit the products for destruction (which should be performed by a duly authorized entity) with the prior authorization of the health authorities. The health authorities are entitled to take interim measures (medidas provisionales) in cases involving imminent risk to health, including the recall of the products from the market and their seizure. If lacking the consent of the holder of the goods, the destruction of the products may only be decreed by the authorities following the relevant sanctioning proceedings. Rights holders may enforce their intellectual property rights before the civil courts (and, in some cases, before the criminal courts). The civil courts, following the applicable procedure, are competent to declare an infringement of intellectual property rights and order the destruction or take other appropriate measures in connection with the falsified goods. In these cases, what will become of the goods generally depends on which measures the rights holder requests within the judicial proceedings. Intellectual property regulations enable the rights holder to request the destruction of the goods, but in some cases they also allow for alternative measures such as the donation of the goods for humanitarian purposes (under trademark laws), or their transformation (under patent laws). It is unlikely, however, that these measures would ever be considered appropriate in the case of falsified medicines. When criminal actions are pursued, the courts may, as interim measures, order the destructions of the goods apprehended, whilst conserving a sufficient number of samples, (to serve as evidence in the proceedings) if this is found to be appropriate due to the nature of such goods or to the danger associated with their conservation. In any case, the final judicial decision should also order the destruction of the goods, as they would not be fit for sale.
8. Do public authorities or non - governmental organizations inform of dangers related to falsified drugs?
Yes. In the last few years, several consumer awareness campaigns have been carried out, both by the health authorities and by private entities, including some pharmaceutical companies, pharmacist’s associations, and patient associations.
9. Have draft acts implementing 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use been already prepared?
Yes. A Draft Royal Decree governing distribution of medicines for human use (Proyecto de Real Decreto sobre Distribución de Medicamentos de Uso Humano) was issued by the Ministry of Health in July 2012 and submitted to the interested parties for their observations. This Draft incorporates certain provisions to implement Directive 2011/62/EU, such as the regulation of medicines brokerage, or the detail of the controls that all suppliers of medicines must perform on their respective suppliers (an obligation which already stems from Spanish law). It does not refer to those measures whose implementation is pending the adoption of delegated acts by the European Commission (namely, the safety features to be included in the outer packaging of medicinal products according to Articles 54. (o) and Article 54a of Directive 2001/83/EC, as amended by Directive 2011/62/EU).
10. Does your jurisdiction consider signature and ratification of the Council of Europe Convention on counterfeiting of medical products and similar crimes involving threats to public health?
Yes. On 13 July, 2012, the Council of Ministers took the formal decision to authorize signature of the Convention.
