CONTENTS HEALTH LAW NEWSLETTER I FEBRUARY, 2017 I COSMETICS AND BORDELINE PRODUCTS 2 II NATIONAL LEGISLATION 4 III NATIONAL CASE-LAW 6 NEWSLETTER I HEALTH LAW WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 2/8 HEALTH LAW NEWSLETTER I COSMETICS AND BORDELINE PRODUCTS The definition of cosmetic products presented by the INFARMED – National Authority for Medicinal and Health Products, Public Institution, in the quality of entity responsible for its regulation, corresponds to “products generally destined to clean, take care or embellish. Some examples of this products include shampoos, shower gels, soaps, face and body creams, deodorants, toothpaste, elixirs, perfumes, hair dyes and makeup”. The qualification of a product as “cosmetic” has the practical effect of conditioning of the legal regime. The fact that the definition of cosmetic product is very wide means it is not always easy to determine precisely the parameters of distinction between cosmetics and other products. Within this context it rises the category of “borderline products”, referent to the products which do not clearly categorize in one or other category. Thus, whenever in doubt about the classification of a product due to its composition, application site, presentation and mode of action, one is facing a borderline product, which should be classified accordingly to a case-by-case basis and considering all of the product’s characteristics. Aware of the difficulties exposed above, the European Commission prepared a set of documents which, even though not having a binding nature, established the orientations and criteria to be applied to the type of borderline products, distinguishing the different situations in the comparison between cosmetic products and medicinal products, toys, biocides, pharmaceutical products, medical devices and others. Following the understanding of the European Commission on this matter, when a borderlineproduct clearly fulfils the requirements of two categories, in other words, when two different regimes are applicable to a sole product, it shall prevail the one that is more demanding. This rule arises from the “principle of non-cumulation”. For example, if a product fulfills the requirements of both the legal definitions of cosmetic and medicinal products, the regime of the latter shall be applied. First and foremost, it shall be reinforced that only the products composed by one substance or a mixture of substances (two or more) are considered medicinal products. In this regard, a tooth brush, despite of being aimed to clean, take care or embellish, shall not be considered as a cosmetic product, to the extent that it does not correspond to a substance or a mixture of substances. On the other side, the tooth paste already qualifies as a cosmetic. Still within this context, the European Commission has specifically approached the distinction between the vehicle products and the cosmetics, clarifying that the product used for the application of a cosmetic (tooth brush, dental floss, wipes, etc) should not be confused with the cosmetic itself. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 3/8 Furthermore, whenever a product is intended to be ingested, inhaled, injected or implanted on the human body, then it shall not be considered as a cosmetic. The criteria of the purpose of the products also performs an important role in the determination of the applicable legal regime to the borderline product. For example, if a cream could be used for healing purposes or merely to correct a body odor, it should be qualified accordingly with the concrete purpose it is being used for. The same applies to a product that performs a skin peeling by removing dead or a layer of cells, which may have a cosmetic function of cleaning the skin or the purpose of correcting physiological function of the skin, like the removal of a scar. In this situations the distinction between a cosmetic product and a medical device may depend on the purpose of the user and the depth of skin affected, considering that for cleaning purposes only a superficial layer will be removed and the product will likely be a cosmetic, and as for other purposes a deeper layer may be removed and the product could be a medical device. The presentation criteria may also have an impact on the classification. On this regard, the European Commission approached the subject of products aimed to address itching, considering that, even if said products have no therapeutic effects, if by virtue of its presentation the averagely well-informed consumer perceives that it has therapeutic or prophylactic properties, it may be considered has a medicinal product rather than a cosmetic. Still in this case, it would be necessary an evaluation of all the product’s elements and, even though “itching” is not necessarily qualified as a disease, it may be presented as a symptom of an underlying disease. If it results from the presentation of the product that it aims to heal the disease that provoked those symptoms, then it might be qualified as a medicinal product. Furthermore, the motivation which leads the consumer to use that product may also be indicative of its correct qualification. Within this context, once again it should considered the concrete situation and all of the product’s characteristics, and the competent authority may use the claim that motivated the use of the product as indicative of one or another qualification, provided that they undertake the due evaluation. The European Commission uses as example the claim referring to a soothing irritation due to in-grown hairs has being possibly associated to a cosmetic product, whereas if the claim is referring to “inflammation” or “infection” then it may be a medicinal product. Finally, it should be mentioned the existence in which is borderline between cosmetics and other category outside of the scope of the pharma sector’s legislation. The situation of a chewing gum composed by a substance that helps to prevent bad breath illustrates very well this category. The substance, rather than the chewing gum has it is only a vehicle product, may be considered as a cosmetic or a medicinal product, but could also enter into the category WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 4/8 of food, if it is destined to be ingested and if the consumer perception fits better in this last category. In light of the above, one can conclude that the qualification of borderline products between cosmetics and other categories is a matter of great relevance, being always dependent of a case-by-case and global evaluation of the product. Many times it are seemingly secondary and non-objective aspects, such as presentation or purpose of use by the consumer, that determine the rightful qualification. II NATIONAL LEGISLATION National Health System Decree-Law 18/2017 – D.R. 30/2017, Series I of 2017-02-10 Regulates the Legal Regime and the Statutes applicable to the health unities of the National Health Service of Public Enterprise nature, as well as to the integrated on the government sector. Dispatch 1348/2017 – D.R. 28/2017, Series II of 2017-02-08 States that the National Health System (NHS) entities and the bodies, departments and agencies of the Health Ministry, shall notify security incidents to the Shared Services for Ministry of Health, Public Enterprise (SPMS, E.P.E.), and within 10 working days designate a person Responsible for the Obligatory Notification (RON) of cyber-security incidents, reporting to the SPMS, E.P.E., the respective names and contacts. Dispatch 1364-A/2017 – D.R. 28/2017, 2nd Supplement, Series II of 2017-02-08 Establishes that the Health System Central Administration, Public Institute (ACSS) shall send to the Office of the Secretary of State for Health information regarding compensatory rest taken by physicians of the National Health System (NHS), as well as the procedures adopted to comply with the measure in question. Dispatch 1729/2017 – D.R. 39/2017, Series II of 2017-02-23 Determines the powers and composition of the Pharmacy and Therapeutic National Commission (PTNC) and the respective articulation with the Pharmacy and Therapeutics Committees (PTC), on the context of acquisition and use of medicinal products on establishments and hospital services of the National Health System (NHS). WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 5/8 Dispatch 1774-A/2017 – D.R. 40/2017, 1s t Supplement, Series II of 2017-02-24 Determines the organization rules and management mechanism referent to the Portuguese Patient Registry (PPR), as well as establishes the criteria and procedures of organization and actualization of the patients’ lists on the Health Centers Groupings (HCG) and their functional units. National Reference Centers Order 52/2017 – D.R. 24/2017, Series I of 2017-02-02 Second amendment to Order 194/2014, of 30 of September, amended by Order 195/2016, of 19 of July, which establishes the concept, identification process, approval and recognition of National Reference Centers for the provision of healthcare services, namely for the diagnostic and treatment of rare diseases. Blood and Transfusion Medicine Dispatch 1649/2017 – D.R. 37/2017, Series II of 2017-02-21 Establishes that the blood and transfusion medicine services activities on a national level are monitored on a centralized basis by the Portuguese Blood and Transplantation Institute, Public Institute (IPST, I.P.), on the context of its legal competencies, and encompasses all hospital entities of the public, private and social sectors which shall guarantee the automated collection of the necessary information. Palliative Care Order 75/2017 – D.R. 38/2017, Series I of 2017-02-22 Second amendment to the Order 340/2015, of 8 of October, amended and republished by the Order 165/2016, of 14 of June, which regulates, on the context of the Palliative Care National Network, the characterization of the services and the admission of local teams and the conditions and requirements of palliative care infrastructures’ construction and security. Drug Addiction Dispatch 1733/2017 – D.R. 39/2017, Series II of 2017-02-23 Criação da Equipa Multidisciplinar para a Coordenação da Área da Dissuasão – EMCAD. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 6/8 Zonas Geográficas Carenciadas Despacho n.º 1788-B/2017 - Diário da República n.º 41/2017, 2º Suplemento, Série II de 2017-02-27 Define as zonas geográficas carenciadas, por estabelecimento de saúde e especialidade médica, para as áreas profissionais de medicina geral e familiar e de saúde pública e para a área hospitalar e especialidade médica indicadas, em 2017, para efeitos de atribuição dos incentivos à mobilidade de trabalhadores médicos. III NATIONAL CASE LAW Decision of the Administrative Central Court of the South of 2 of February 2017 The Public Prosecution has presented a declaratory relief against the Ministry of Health regarding the declaration of illegality with general mandatory force of regulations, as it considered that the materialized and preprinted prescription templates, which are compulsory under Dispatch 15700/2012, of the Secretary of State for Health, of 30 of November, were contradictory to the law because the patient should indicate whether or not he wanted to exercise the right of option for a medicinal product other than the one foreseen in the prescription, namely a cheaper medicinal product with the same active substances. Having the Lisbon Administrative Court pronounced the claim as admissible and well founded in the decision of 24.09.2015, the Health Ministry, disagreeing with said ruling, appealed for the Administrative Central Court of the South. The fundament of their claim was the understanding that, even though the law establishes that the exercise of the right of option for a cheaper medicinal product in the market should occur in the moment of the dispensing in a pharmacy and not at the time of the prescription by a physician, the fact that in the medical prescription is included the statement “I intend to use my right of option…” and two spaces to indicate the “Yes” or “No” option, to be fulfilled by the patient, does not mean that the right would be exercised at that moment, but it would only be a mere declaration of intent of using this right later, on the moment of the prescription. The patient would be reserving the possibility of a future exercise of the right. This understanding would be allegedly supported by the fact that the exercise of the right could only be carried out by a formal and explicit declaration by the patient on the moment of the dispensing, wherefore it could not ever be exercised in advance and, therefore, this mention could not be interpreted as said exercise. In turn, the Public Prosecution has argued that that the Dispatch did not comply with the objective requirements for the validity of regulatory rules, as it would contradict the regulatory pack of rules for administrative public activity. Thus, as the right of option should only be exercised in the moment of the dispensing, this option should not be included in the medical prescription, as it would be an anticipation of the exercise to the time of the prescription. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 7/8 In the reasons behind its decision the Administrative Central Court of the South considered that the understanding of the Administrative Court of First Instance was correct. To the extent that the legislator has explicitly foreseen that the right of option should be exercised in the moment of the dispensing and that he did not require that it was exercised in front of a physician or that the patient should reserve the exercise of the right of option for a subsequent moment, it is not comprehensible that the patient has to indicate during the prescription the intent of using said right when he will have to repeat that declaration afterwards, on the moment of the dispensing. Furthermore, it also reinforces this position the fact that only in that subsequent moment of the dispensing the patient as gathered all the necessary information for the exercise of the right. The understanding of the Public Prosecution and the Administrative Central Court of the South of the requirement that the patient indicates in the moment of the prescription, through the fulfillment of one of two option spaces, respectively for “Yes” or “No”, in front of the question ”Do you intend to exercise the right of option?” his intention to exercise said right, is that it is illegal, as that is not the moment determined by the legislator for the exercise of the right of option, and even if it only was considered a reservation of a future exercise, it never was imposed or justified by a legal rule. Therefore, the Administrative Central Court of the South dismissed the appellant’s action and confirmed the appealed decision, stating that the part of the Dispatch 15700/2012 referent to the right of option should be considered, with general mandatory force, as illegal. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 8/8 CONTACTS CUATRECASAS, GONÇALVES PEREIRA & ASSOCIADOS, RL Sociedade de Advogados de Responsabilidade Limitada LISBOA Praça Marquês de Pombal, 2 (e 1-8º) I 1250-160 Lisboa I Portugal Tel. (351) 21 355 3800 I Fax (351) 21 353 2362 firstname.lastname@example.org I www.cuatrecasas.com PORTO Avenida da Boavista, 3265 - 5.1 I 4100-137 Porto I Portugal Tel. (351) 22 616 6920 I Fax (351) 22 616 6949 email@example.com I www.cuatrecasas.com This Newsletter was prepared by Cuatrecasas, Gonçalves Pereira & Associados, RL for information purposes only and should not be understood as a form of advertising. The information provided and the opinions expressed herein are of a general nature and should not, under any circumstances, be a replacement for adequate legal advice for the resolution of specific cases. Therefore, Cuatrecasas, Gonçalves Pereira & Associados, RL is not liable for any possible damages caused by its use. Access to the information provided in this Newsletter does not imply the formation of a lawyer-client relationship or of any other sort of legal relationship. This Newsletter is published free of charge and may not be copied or distributed without formal prior consent. If you do not wish to continue receiving this Newsletter, please send an e-mail to firstname.lastname@example.org.