dimanche 20 décembre 2009



Petition 6/2009


The petition


The petitioner, a French citizen, obtained his State qualification of Doctor of Pharmacy in July 1998. He became a member of the “Ordre National des Pharmaciens” in 1998 and the Royal Pharmaceutical Society of Great Britain in October 1998. He has since been practising in the United Kingdom.

In May 2007, ASDA Store Management refused to appoint him "in-store pharmacist" in a pharmacy on the grounds that he obtained his qualifications in France. He challenged that decision with the Department of Health which informed him that the question of access of European citizens to the management of new pharmacies is under examination but that Member States are free to choose to apply the exception provided by Article 2§2 of EEC Directive 85/433[1].

Furthermore, the petitioner considers that by authorising citizens of third party countries who obtained their qualifications in England to hold positions in the new pharmacies, the United Kingdom is committing discrimination on the basis of nationality.


OBSERVATIONS OF THE COMMISSION REGARDING THE PETITION

As a preliminary comment, it should be noted that following the cancellation of EEC Directive 85/433 by Article 62 of EC Directive 2005/36[2], recognition of professional qualifications, particularly pharmacists, is organised by that second directive which came into force on 20th October 2007.

Article 21§4 of EC Directive 2005/36 provides the same exception as that which appeared in Article 2§2 of EEC Directive 85/433. This exception authorises Member States not to recognise the training qualifications mentioned in Appendix V.5.5.2 of the Directive for creating new pharmacies open to the public. New pharmacies are deemed to be those opened less than three years ago. This derogation authorises Member States not to grant automatic recognition to holders of the qualifications mentioned in the appendix to the directive.

However, this does not mean that Member States can refuse authorisation to a national of a Member State to be appointed to a new pharmacy simply by referring to Article 21§4 of EC Directive 2005/36. This article does not allow the Treaty and in particular its Article 43 which guarantees freedom on establishment to be bypassed. Pursuant to that article, recognition of professional qualifications must be granted by taking into consideration all the qualifications and professional experience of the person wishing to be appointed to a new pharmacy. On the other hand, access to a position itself cannot be refused on the sole basis of Article 21 § 4 the purpose of which is simply to bypass the automatic recognition procedures. A possible refusal on the basis of the Treaty must be motivated in the light of the Gebhard judgement[3] which provides that “national measures to impede or render less attractive the exercise of basic liberties guaranteed by the Treaty must fulfil four conditions: that they are applied in a non-discriminatory manner, that they are justified for pressing reasons of general interest, that they are suitable for guaranteeing the achievement of the objective they pursue and they do not go beyond what is necessary to achieve it.”

With regard to the alleged discrimination by the United Kingdom on the basis of nationality, it should be noted that, according to information available to the Commission, the United Kingdom refuses to recognise only qualifications obtained in other Member States; a national of a Member State who obtains his qualifications in the United Kingdom is not affected by this restriction. The petitioner obtained his qualifications in France, he is not in the same position as a national of a third party country or a national of a Member State who obtained his qualifications in the United Kingdom. People who find themselves in different legal positions may have different rules applied to them without however being the subject of discrimination.

Conclusion

Article 21§4 of EC Directive 2005/36 allows Member States not to grant automatic recognition to pharmacist qualifications obtained in other Member States for being appointed to practice pharmacy in new pharmacies. This provision does not however refuse access to that activity. The restrictions complained of by the petitioner must be assessed on the basis of Article 43 TCE (Treaty of Rome). The Commission will contact the United Kingdom to check whether these principles are being adhered to in the legislation and the way they are being applied.

[1] EEC Council Directive 85/433 of 16th September 1985 relating to mutual recognition of diplomas, certificates and other qualifications in pharmacy and including measures intended to facilitate the actual exercise of the right of establishment in respect of certain activities in the field of pharmacy, OJ L 253 of 24.9.1985, p. 37–42
[2] EC European Parliament and Council Directive 2005/36 of 7th September 2005 relating to the recognition of professional qualifications, OJ L 255 of 30.9.2005, p. 22–142

[3] Case C-55/94, Gebhard, point 39

Pharmacy bodies call for removal of “three year rule”


Thu, 17/12/2009 - 14:56



Pharmacy organisations have called for the removal of a rule in UK legislation that prevents EU-qualified pharmacists from being appointed as the pharmacist in charge of new premises.

In a letter to the Department of Health, the Royal Pharmaceutical Society, the Pharmaceutical Services Negotiating Committee, the Association of Independent Multiples, Community Pharmacy Scotland, the Pharmaceutical Society of Northern Ireland, the Company Chemists’ Association and the National Pharmacy Association request that the “three year rule” is removed from relevant legislation at the earliest opportunity.

The rule prohibits EU-qualified pharmacists from acting as a responsible pharmacist unless the pharmacy premises has been registered with the Society for more than three years. The co-signatories agree that the current legislation does not offer any public benefit or protection.

CO/1466/09 IN THE HIGH COURT OF JUSTICEQUEEN'S BENCH DIVISION THE ADMINISTRATIVE COURT Royal Courts of Justice StrandLondon WC2A 2LL Wednesday, 14th October 2009


B e f o r e: MR JUSTICE KENNETH PARKER Between: THE QUEEN ON THE APPLICATION OF TAGA Claimant v DEPARTMENT OF HEALTH Defendant


Computer‑Aided Transcript of the Stenograph Notes of WordWave International LimitedA Merrill Communications Company 165 Fleet Street London EC4A 2DYTel No: 020 7404 1400 Fax No: 020 7831 8838(Official Shorthand Writers to the Court)


The Claimant appeared in Person Mr T Eike (instructed by Treasury Solicitor) appeared on behalf of the Defendant


J U D G M E N T (As Approved by the Court) Crown copyright©

1. MR JUSTICE KENNETH PARKER: This is an application for permission to apply for judicial review brought by Dr Taga in person, seeking a prohibiting order preventing the defendant Secretary of State from not allowing European pharmacists to work as locum pharmacists in new pharmacies open to the public, a declaration of incompatibility derived from the misinterpretation of Directive 85/433 EC, and damages claimed under the Human Rights Act 1998, amounting to £1.2 million.

2. Underlying this application for permission to apply for judicial review is the application to Dr Taga, a pharmacist qualified in France and registered with the Royal Pharmaceutical Society of Great Britain, under section 4A of the Pharmacy Act 1954 of section 71(1) of the Medicines Act 1968 (as amended by Regulation 3(2) of the Pharmaceutical Qualifications EEC Recognition Order 1987, SI 1987 No 2202). This provision at all relevant times made it a condition for the carrying on of a retail pharmacy business by a body corporate that, firstly, the business is carried on at all times under the personal control of a superintendent or a manager or assistant who is a pharmacist, and secondly, where those premises in Great Britain have been registered pharmacists for less than 3 years, it is under the personal control of persons, none of whom whether the superintendent or manager or assistant, is a pharmacist by virtue of section 4A of the Pharmacy Act 1954.


3. The relevant aspects of this section, as introduced by Pharmaceutical Qualifications EEC Recognition Order 1987 SI 1987 No 2002, is based on Article 2(2) of Council Directive 85/433, which provides that under paragraph 1:"Each Member State shall recognise the diplomas, certificates and other formal qualifications listed in Article 4 awarded to nationals of Member States by other Member States in accordance with Article 2 of Directive 85/432/EEC by giving such qualifications, as regards the right of access to and pursuit of the activities referred to in Article 1, the same effect in its territory as those diplomas, certificates and other formal qualifications, listed in Article 4, which it itself awards." The material provision for this application is paragraph 2, which provides: "However, Member States need not give effect to the diplomas, certificates and other formal [qualifications] referred to in paragraph 1 with respect to the establishment of new pharmacies open to the public. For the purposes of applying this directive, pharmacies which have been in operation for less than three years shall also be regarded as new." I pause only to observe that the derogation, as I shall call it, in Article 2(2) is in unqualified terms and does not impose any restrictions on Member States or other conditions as to its application.


4. Briefly, I will refer to the facts of the case. Dr Taga is a French pharmacists holding a deplôme d'etat de docteur en pharmacie from the faculty of Pharmacy of Paris 5 obtained in July 1998. This diploma is identified in Article 4 of Directive 433/85 and now paragraph 5.6.2 to annex 5 to Directive 36/2005 and schedule 1A of the Pharmacy Act 1954, as one that is required to be recognised by other Member States under Article 2 of Directive 433/85 and now Article 21(1) of Directive 36/2005.

5. As a consequence, in application of section 4A of the Pharmacy Act 1954, upon his application on 5th October 1998 the Royal Pharmaceutical Society of Great Britain registered Dr Taga as a pharmaceutical chemist, a member of The Royal Society under registration No E 500. Dr Taga states that he has worked in various positions as a locum pharmacist in the United Kingdom between 5th October 1998 and 4th February 2007.


6. On 5th February 2007 Dr Taga was offered a permanent position as a pharmacist by Asda in their Harlow store with a start date of 15th February 2007. It appears the Harlow store, at least the pharmacy in it, was a new pharmacy due to open on 14th May 2007. However, by letter dated 11th May 2007 Asda informed Dr Taga that as a result of the requirements of the Medicine Act 1968, he was not allowed to be the pharmacist in charge. His probationary period had been extended to see if there were any other pharmacy vacancies that they could discuss with him and if they were unable to find a suitable position, they might have to dismiss him with notice.


7. After some other events that I need not go into, by letter dated 2nd July 2007, the Department wrote to Dr Taga and indicated that despite amendments to the Medicine Act 1968 introduced by the Health Act 2006 the requirement under section 71 of the Medicine Act and I quote from the correspondence: "... remains and further legislation will be needed to change the position on pharmacists qualified in another EU State and their ability to be in charge of a pharmacy that has been open less than 3 years. The government will look to pharmacy owners, pharmacists and pharmacy organisations to communicate any support for such a change." The Department also remarked that the more recent directive on mutual recognition of qualifications (36/2005) contained an almost identical provision to Article 2(2) and indicated that: "The government's view is that Member States may choose or may not choose to take up this discretionary derogation." Finally, the Department indicated its view in relation to the forthcoming changes from a pharmacist being in personal control of a registered pharmacy to each pharmacy having to have a responsible pharmacist as introduced by the Health Act 2006. The Department said: "The department believes that the greater clarity on how the pharmacist in charge of the pharmacy is to discharge a statutory duty for the safe and effective running of the pharmacy will mean that he or she will need some experience of working in the sector such as community or hospital pharmacy before taking on those important duties. The intention is that such requirements will apply to all pharmacists wishing to take on those responsibilities or whether the registered here or another EU Member State. The department will be consulting with all interested parties on these matters including the timing of introduction as part of developing the regulations."

8. By virtue of the Health Act 2006 (Commencement No 6 Order) 2008 SI 2008 No 2718, made on 14th October 2008, the relevant amendments to section 71 of the Medicine Act 1968 introduced by the Health Act 2006 will only come into force on 1st October 2009. That date has now of course passed.

9. The new section 71 of the Medicine Act 1968, as substituted by the Health Act 2006 expressly provides in subsection (5) that:

"In relation to premises in Great Britain that have been registered pharmacists for less than three years, the responsible pharmacist may not be a person who is pharmacists by virtue of section 4A of the Pharmacy Act 1954 (qualification by European diploma) or any corresponding provision applying to Northern Ireland."


Therefore, as the letter of 2nd July explained, this does not alter the position in relation to pharmacists qualified in another EU Member State. I also note that on 5th January 2009, Dr Taga lodged a petition with the European Parliament complaining of discrimination, misinterpretation of the directive and breach of Directive 78/2000.

10. On 7th July 2009 the EP Committee on petitions notified its members of the reply by the EC Commission to the claimant's petition. In its answer the Commission made clear that, firstly, as the claimant obtained his qualification in France, for the purpose of any discrimination argument he is "not therefore in the same situation as a citizen of a third country or Member State who had obtained his qualifications in the United Kingdom. Persons in different legal situations may find themselves subject to different rules without being the subject of discrimination". Secondly, the Commission could not form a final view on the compliance of UK law with EC law until it had contacted the United Kingdom "to verify whether these principles [that is, of EC law] are being respected." The Commission approached the United Kingdom authorities on 3rd September 2009. Discussion between the Commission and the defendant are, I am told, ongoing.

11. I look then at the grounds relied upon. The preamble to Directive 433/85 expressly provided as followed:


"Whereas, under their national policies in the sphere of public health, which seek inter alia to ensure the satisfactory dispensing of medicinal products over their entire territories, certain Member States restrict the number of new pharmacies that may be established, while others have adopted no such provisions; whereas in these circumstances it is premature to provide that the effects of the recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy must also extend to the pursuit of the activities of pharmacist as the controller of a pharmacy open to the public for less than three years; whereas this problem must be re‑examined by the Commission and the Council within a certain period."

12. The effect of Article 2(2) of the Directive was the subject of express consideration by the European Court of Justice in case C 221/05 Sam Mc Cauley Chemists (Blackpool) Ltd Mark Sadja v Pharmaceutical Society of Ireland Minister for Health and Children. Ireland Attorney General [2006] ECR 1‑1869. In that case the ECJ was concerned with Irish legislation equivalent to section 71 of the Medicine Act in relation to the exemption for new pharmacies open to the public for 3 years or less. The question posed by the Irish Supreme Court was:


"... whether Article 2 of Directive 85/433 merely imposes an obligation on Member States to recognise diplomas, certificates and other formal qualifications (‘diplomas’) in respect of activities in pharmacies which have been in operation for at least three years or whether, in addition, it confers on them a discretion whether to extend the recognition of diplomas with respect to the establishment of new pharmacies open to the public, as defined in Article 2(2) of that directive..."

13. In its judgment the ECJ stated that the EC legislature is free to introduce harmonisation in stages, having regard to the fact that it is generally difficult to implement harmonising measures because it requires the competent institutions to draw up on the basis of diverse and complex national provisions common rules in harmony with the aims laid down by the treaty and approved by a qualified majority of the Members of the Council, or even the unanimous agreement of the latter. The ECJ held, as regards recognition of diplomas in pharmacy, that it was the aim of the Community legislature, in adopting the Directive 433/85, to introduce partial harmonisation guaranteeing a minimal level of recognitions of those diplomas, namely recognition with respect to the pursuit of activities in pharmacies which have been in operation for at least 3 years while providing Member States with a possibility to go beyond the minimal requirements imposed by the Directive. It follows from a reading of Article 2, in its entirety that the provision imposes an obligation and a mutual recognition only in respect of pharmacies which have been in operation for at least 3 years. Thus where a Member State complies merely with that minimal level of recognition of diplomas it is not exercising any discretion stemming from Article 2 of Directive 433/85.

14. The court also dealt with Article 43 and its application to the circumstances of the derogation. The court noted at paragraph 22 that Article 43 provides that, within the framework of the provisions of the EC Treaty and the right of establishment, restrictions on the freedom of establishment of the nationals of a Member State in the territory of another Member State are prohibited. The court went on in paragraph 23 to say those provisions include Article 47/EC, which empowers the Council to issue Directives for the mutual recognition of diplomas, in the case of, inter alia, the pharmaceutical professions. Then in paragraph 26 the court stated:


"As regards the scope of those directives, Article 47 EC confers on the Community legislature the power to harmonise completely, where appropriate, the diplomas concerned, while leaving to the legislature’s judgment the manner in which it is to go about achieving such an objective. Therefore, the legislature is free to introduce harmonisation in stages..."


15. On 7th March 2002 the Commission published its proposals for a directive of the European Parliament and of the Council on the recognition of professional qualifications (COM 2002 0199 final). This proposal eventually led to the repeal of Directive 433/85 and the adoption of Directive 36/2005. In its proposal the Commission did not include any provision similar to Article 2(2) of Directive 433/85, and expressly stressed that its proposal provided an extension of automatic recognition, on evidence of training as a pharmacist to the setting up of new pharmacies open to the public.


16. Following proceedings in the Parliament, the formal position of the European Parliament adopted on 11th February 2004, included, as Article 54(4) of the Directive (the draft directive as it then was) the wording now reflected in Directive 36/2005. While the Commission in its modified legislative proposals (CON/2004 0317) considered these proposed amendments unacceptable, the Council of Ministers in its common position, adopted on 21st December 2004, confirmed the approach of the European Parliament and introduced Article 21(4), as it was eventually enacted:


"Member States shall not be obliged to give effect to evidence of formal qualification referred to annex 5.5.6.2 for the setting up of new pharmacies open to the public. For the purposes of this paragraph, pharmacies which have been open for less than 3 years will be considered as new pharmacies."

17. On the basis of this legislative material it appears to me it is not properly arguable that the provisions of section 71 of the Medicine Act are ultra vires the provisions of Directive 36/2005. The provisions of that Act reflect faithfully the provisions of the Directive, which I have already indicated are in unqualified and unconditional terms.


18. The position, as it was held to be under Directive 433/85, remains unaltered, and Member States are not required as a matter of EC law to recognise qualifications obtained in other Member States in relation to new pharmacies. If there were any doubt about it, the matter, in my judgment, has also been conclusively resolved by the European Court in the case to which I have referred.


19. That really is the main thrust of the attack in this application. The applicant has relied on further Directives, Directives 78/2000 and 38/2004 and 43/2000. These Directives predate, both the adoption of Directive 36/2005 and the judgment of the European Court in the case to which I have referred, and both of these expressly authorise the approach taken by section 71. However, I have considered the terms of the directives that are relied on and in my judgment they do not arguably support the position which the claimant wishes to contend for in this application.

20. So far as the compatibility of the derogation, whether in the original or in the new Directive is concerned, it seems to me again that the European Court has implicitly dealt with that matter in the case referred to. In any event, this court would not be able to declare the provision incompatible with Community law, but I do not see, at this stage, any grounds upon which the compatibility could be seriously challenged.


21. So far as the claim for damages is concerned, in my judgment, this stands or falls with the main application. For the reasons I have given the United Kingdom is not in breach of the directive and so the first and preliminary condition necessary to sustain any action for damages, namely that the Member State is in serious disregard of its obligation under the treaty, failing to implement a directive, cannot be made out.


22. I should say however, at the end of this matter, I do have considerable sympathy for the position of the claimant. It does appear that this derogation stems from a period now considerably in the past, and that its rationale was to restrict pharmacists from other Member States coming to the United Kingdom and establishing pharmacies here. On the face of it, the derogation does seem to be principally directed, at least on the materials I have seen, to impeding the flow of trade between other Member States and the United Kingdom. There may be other justifications of which I am not aware, but it does seem to me that, as a general matter, the claimant's position is deserving of some sympathy. According to his evidence, he is not only qualified but he also has considerable experience in the United Kingdom.

Therefore, so far as experience and expertise is concerned, and so far as issues about potential damage to the welfare of patients or the community more generally in the United Kingdom are concerned, it does not seem there is very great justification in preventing him from proceeding as he would wish to do. However, it seems to me, for the reasons I have given, that the law is absolutely clear. The derogation is lawful and the United Kingdom has properly implemented the relevant directive.


23. Therefore, for those reasons I dismiss this application for permission.

24. MR EIKE: I am grateful my Lord. That leaves two applications. The first being we could ask the court for a transcript of your Lordship's ruling. Your Lordship will be aware there is ongoing discussions with the Commission, and if it may help all parties involved. The second application is to renew the application for costs which Dobbs J awarded in the sum of £400 towards the cost of preparing the acknowledgement of service.


25. THE DEPUTY JUDGE: Yes.


26. MR EIKE: On the usual basis my Lord.

27. THE DEPUTY JUDGE: I will certainly order a transcript. Do you need that as a matter of expedition or?

28. MR EIKE: My Lord, if that were possible we would be very grateful.


29. THE DEPUTY JUDGE: I think it is justified given the matter is of contemporary relevance the transcript should be provided with expedition and I assume Dr Taga will be given a copy as well.

30. MR EIKE: Yes of course.


31. THE DEPUTY JUDGE: You will receive a copy of the transcript of the judgment. Do you have anything to say about the costs application?

32. THE CLAIMANT: Your Lordship, as you can imagine I don't have any means to have actual legal representation, that is why I have to represent myself. I have got eleven children. It's not easy for me, so I rely on your Lordship's discretion actually to see what can be done about the costs.

33. THE DEPUTY JUDGE: Again, I am sympathetic to your personal position but, as a matter of principle, the defendant is entitled to their costs. They successfully defended this application, and I am sure that their costs as a whole, including the appearance of Mr Elke and the work that he's done, which was invaluable to me, will have exceeded the amount that in fact is being claimed. Therefore I think it is fair and reasonable in the circumstances that the defendant should have their costs which I summarily assess in the amount of £400.


34. MR EIKE: I am grateful.