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Spain

Farmacéutico (Spain)


  • Proportionality information

    1. Have you examined whether the requirements under your national legal system are
    directly or indirectly discriminatory on the basis of nationality or residence?
       

    Yes. There is no discrimination since the requirements are applicable to nationals of any of the Member States under Royal Decree 1837/2008, of November 28th, which transposes into the Spanish legal system the requirements provided by Directive 2005/36/CE.

    There is no regulation that discriminates on the grounds of neither nationality nor residence.



    2. Which of the following overriding reasons relating to the general interest justifies the measure(s)?
         
    • Public health
    •    
    • Protection of consumers and recipients of services

    3. What specific risks or benefits have you identified that your measure(s) is designed to, respectively, minimise or maximise?

       Please try to be specific in describing the nature of the risks/benefits you have identified
       Where you have selected more than one overriding reason relating to the general interest in question 2 please be sure to address each of these in your response. Wherever possible please include evidence.

       
    • Ensuring an adequate control of professional practice for an optimum consumer protection.
    • Minimising the risks associated with the use of medicines on the health of citizens.
    • Minimising the risks for general interest and public health that could arise from inadequate provision of medicinal products to the public.
    • Contributing  to efficiency, sustainability, and financial balance of the health care system (Social Security).
    • Assuring pharmacists independent professional action.
    • Avoiding conflicts of interest.
    • Ensuring responsibility.

    4. How specifically do your measures operate to minimise the risk(s) or maximise the benefit(s) identified in question 3?

       When addressing this question please try to explain how the measures prevent the risks or guarantee the benefits.
       Where you have selected more than one overriding reason relating to the general interest in question 2 please be sure to address each of these in your response. Wherever possible please include evidence.

       

    These measures guarantee professional practice in a vis-à-vis contact with consumers. The CJEU has acknowledged that compulsory licensing is compatible with European Union law on grounds of general interest. Thus, citizens are guaranteed that the professional pharmacist has the qualification certifying his/her training and education; together with deontological and disciplinary control and the promotion of the professional development.

    The CJEU has analysed and resolved in the following decisions (19th May 2009 Commission/Italy, C-531/06, EU:c:2009:315, paragraphs 52, 57, 58, 61, 64, 84, 86, 90 and Apothekerkammer des Saarlandes and others, C-171/07 and C-172/07, EU:C:2009:316, paragraphs 28, 33, 34, 54, 56, 57, 60, 61, 64, 84 and 1st July 2010 Blanco Pérez and Chao Gómez, C-570/07 and C-571/07, EU:C:2010:300, paragraphs 64, 65, 66, 75, 84 that: May 19th, 2009, Commission/Italy, C-531/06, EU: C: 2009: 315, paragraphs 52, 57, 58, 61, 64, 84, 86, 90, Apothekerkammer des Saarlandes and others, C-171/07 and C-172/07, EU: C: 2009: 316, paragraphs 28, 33, 34, 54, 56, 57, 60, 61, 64, 84 and July 1st, 2010, Blanco Pérez and Chao Gómez, C-570/07 and C-571/07, EU: C: 2010: 300, paragraphs 64, 65, 66, 75, 84) that they guarantee the independence of action of pharmacists, minimize the risks associated with the incidence of drugs on the health of citizens, minimize the risk for general interest and public health that could arise from an inadequate provision of medicinal products to the public, contribute to efficiency, sustainability and financial balance of the system, and ensure the responsibility of the professional as well.


    5. In so far as you are able, please provide information that you have gathered regarding the concrete effects of the measure(s).

       For example, through impact assessments or information gathered during implementation or review of a measure. Member States who have recently undergone reforms may in particular be able to contribute helpfully to this field. Where you are able to provide cost-benefit analyses this would be particularly valuable.
       Information on whether the measures indeed successfully prevented risks from being realised (e.g. the number of sanctions imposed, a drop in transgressions since the measure was introduced or consequences from previous modifications of the regulation) would equally be helpful.
       Where you have selected more than one overriding reason relating to the general interest in question 2 please be sure to address each of these in your response. You may also wish to include evidence on consumer satisfaction or other measurements of the impact.

       

    The specific effects of the above-mentioned measures would be the following: (i) ensuring the prevalence of the professional criteria with respect to the economic criteria; (ii) maintaining stocks of the medicines needed to ensure an adequate supply; (iii) collaborating with the NHS at dispensing medicinal products and providing unpaid care services; (iv) collaborating in the responsible use of medicines with cost reduction for NHS; (v) promoting the implementation of strategic projects for the NHS such as the Electronic Prescription Service; (vi) avoiding medicine-related problems; (vii) hindering the entry of counterfeit medicines thanks to strict control and providing access to medicines through the network of 21,800 pharmacies attending an average of 2,140 inhabitants per pharmacy, ensuring that 99.9% of people have access to a pharmacy near their place of residence, 2/3 of pharmacies being located outside provincial capitals, with 2,081 pharmacies located in towns with less than 1,000 inhabitants, of which, 1,111 are in towns of less than 500 inhabitants; (viii) providing 24 hour-coverage, 365 days a year, bearing the costs of maintenance of the aforesaid services.


    6. Is the general interest objective you indicated in question 2 pursued in a consistent and systematic manner?.

       In approaching your response to this question please consider examples where you have addressed similar risks for comparable professions, not necessarily within the same sector. Is the approach you have adopted in this particular profession comparable or distinct from such similar cases and why?

       

    The CJEU, in its decision of March 10th, 2009, Hartlauer, C-169/07, EU:C:09:141, paragraph 55, recalls that national legislation is appropriate for ensuring attainment of the objective pursued only if it genuinely reflects a concern to attain it in a consistent and systematic manner. In infringement cases brought by the Commission, there have been discussions concerning alternative mechanisms such as mandatory presence of pharmacists at pharmacies, the obligation to take out insurance or a system of adequate controls and effective penalties. The CJEU, in its decision of May 19th, 2009, Commission/Italy, C-531/06, EU:C:09:315, paragraphs 84 to 88, and Apothekerkammer des Saarlandes and others, C-171/07 and C-172/07, EU:C:09: 316 paragraphs 53 to 57, states that a Member State may adopt the position that there’s a risk that legislative rules designed to ensure the professional independence of pharmacists are not observed in practice, given that the interest of a non-pharmacist in making profit would not be tempered in a manner equivalent to that of self-employed pharmacists and given the fact that pharmacists, when employees, work under an operator and this could make it difficult for them to oppose instructions given by their respective superior. 


    7. Please explain in how far the degree of complexity or the nature of the activities
    which are reserved justify that these activities can be exclusively performed by professionals possessing a specific professional qualification?

       For example: when the tasks are essentially of a straightforward nature (such as preparing and printing pay slips etc.), or involve essentially the execution of instructions, specific professional aptitudes should not be required.

       

    In most Member States, pharmacists, as experts in medicines, are mandated to guarantee citizens’ access to the medicines that are necessary to restore their health, including in the case of Spain, the effective guarantee of rational use and pharmaceutical care. In this sense, Directive 2005/36/CE on professional qualifications (recently modified by Directive 2013/55/EU, of November 20th and especially its article 45, paragraph 2, referring to official university degrees for the profession of pharmacist) implements training activities and minimum knowledge. This question has been analysed and resolved by the CJEU in its decisions of May 19th, 2009, Commission/Italy, C-531/06; EU:C:2009:315, paragraph 90, and Apothekerkammer des Saarlandes and others, C-171/07 and C-172/07, EU:C:2009:316, paragraph 60.


    8. Where you have indicated several measures in place in the screening tab,
    have you reviewed the cumulative effect of all these measures on professional activities?

       If not, why not?
       If yes, please outline for us how you approached assessing this issue as well as the results and conclusions or any learning you drew from this. Where possible please include evidence.

       

    Yes. The cumulative effect of the measures stemming from the restriction of access to the activity, the compulsory licensing and the management of pharmacies constitute a maximum guarantee of public health for Spanish citizens. Indeed, public health and the right of citizens to health protection in Spain are guaranteed at a maximum level by the European Union by enforcing basic health standards, the management of pharmacies and the collaboration of these healthcare facilities with the NHS via the Pharmaceutical Organisation. These regulatory provisions have been assessed by the case-law of the CJEU, as being non-discriminatory, necessary, proportional and justified on grounds of the general interest, for the benefit of citizens, in line with the terms of the Treaties, among which people's health and life are superior interests and protected by the European Union.[BD1] 

     

    It has recently been observed in certain Member States (Switzerland, England, Norway and Hungary) that the deregulation of pharmacies can entail concentration effects within the most economically profitable urban areas, where there is already good accessibility. The EU has analysed the possible application of alternative less restrictive mechanisms to assess if the Spanish legislation related to the management and planning of pharmacies does not exceed what is necessary to achieve the objective of public health. The CJEU considers that, in the light of the discretion enjoyed by the Member States in relation to the protection of public health, a Member State may consider that the 'minimum number' system is less effective than the current system by ensuring that the provision of medicinal products is reliable and of good quality in less attractive areas.

     [BD1]Necesario? SB-CG. Problema de exceso de caracteres. Está en parte en respuesta 1.



    9. Have you considered the use of alternative mechanisms to achieve your objective(s)?

       Please briefly explain. Where you have selected more than one option, please be sure to address each of these in your response.

       

    No. The alternative mechanism regarding compulsory licensing would be non-compulsory licensing. Such mechanism is not as efficient as the current system, in view of the limitations to the performance of the described functions that would be entailed if only a part of the profession, composed of those who voluntarily chose to be a member of the Pharmaceutical Organization, was gathered. Furthermore, in terms of material means, this would provide minor protection and guarantees to citizens. The restriction of access to the activity is provided by Directive 2005/36/EC (art. 44, 45). The above mentioned alternative mechanism of management of pharmacies has already been subject to the assessment of the CJEU in decisions of May 19th, 2009, Commission/Italy, C-531/06, EU:C:2009:315 and, Apothekerkammer des Saarlandes and other, C-171/07 and C-172/07, EU:C:2009:316, and of June 1st, 2010, Blanco Pérez and Chao Gómez, C-570/07 and C-571/07, EU:C:2010:300, whereby the CJEU concluded that it has not yet been evidenced that a measure, different from the principle of exclusion of non-pharmacists, would guarantee the same level of safety and quality in the provision of medicinal products to people with the same degree of efficiency as the current system does.

     


    10. Conclusion

       Following your internal examination of this regulated profession, which of the following have you concluded?

    •    Maintain current system

       Explain where relevant:

       The current system must be mantained.

    11. Any other comments?
       

    No further comments.

     

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