Directives and Regulations: a question of perspective

1. Directives and Regulations:a question of perspective Pharmaceutical Trade Marks Group 20 March 2012

2. Where does EU law come from? • The initiative to make law lies with the Commission • Parliament and Council split the task of scrutinising and amending the Commission’s proposals • Parliament and Council can suggest new laws, but the Commission decides the form they take

3. Where does EU law come from? • Proposals can be challenged by national governments if they violatethe principle of subsidiarity

4. From no decision to codecision • “Codecision” is the usual route, with the proposal shuttling between the Commission, the Council and Parliament (i) until there’s consensus or (ii), if the Commission rejects amendments, where the Council is unanimous

5. Where does EU law come from? • If none of this works, the Presidents of the Council and the Parliament convene a Conciliation Committee, which has just six weeks to agree a text.

6. There’s also a speciallegislative procedure … • The Consultation Procedure • Council (unanimously or not, depending …) can adopt a Commission proposal after a non-binding consultation with Parliament • In practice, Parliament’s opinions are often ignored or even sought after the event — though the CFEU says this is naughty: Case 179/80 Roquette Frères v Council [1980] ECR 3333.

7. There’s also a special legislative procedure … • Consultation Procedure: most commonly used before the Single European Act came into force in July 1987 • Still used for legislation on internal market exemptions and competition law

8. … and that’s not all … • Consent procedure (cutting out Parliament’s powers to propose amendments) • Commission and Council can act alone • Sometimes the Commission can act alone

9. … and we’re not finished yet! The Lisbon Treaty 2009 added further legislative techniques: • “Ordinary” and “simplified” revision procedures • The Passerelle Clause, which lets the Council unanimously jettison unanimous voting in favour of a qualified majority, if Parliament has already given it its blessing

10. Acts of the European Union • Regulations, which have direct effect — though some still require subordinate legislation before they can work • Directives, which require to be “transposed” into national law • Decisions, which have direct effect but only affect the person or entity to which they are addressed • Recommendations, which are non-binding • Opinions, which are even more non-binding

11. Regulations • Legal basis: Article 288 TFEU • Override earlier incompatible national law and invalidate later national law • 26% of Regulations passed since1957 are still in force • Implications of the acquiscommunautairefor new entrants

12. Directives • Binding as to ends to be achieved, but leave means to each Member State • Need not be addressed to every Member State — though in practice they are • Failure to implement can lead to legal action against the Member State, both by the Commission and by adversely affected indidivuals

13. How much of it is there? • Open Europe counted 666,879 pages of Official Journal, the weight of a rhinoceros • Only 285 kg represents law still in force

14. Input in law-making • Economic, social and environmental impact considered • Interested parties and the public are consulted • Opinion of the European Data Protection Supervisor • Comitology …

15. Cutting the clutter • Regulations and Directives get codified: this means that existing legislation gets recast and consolidated • Recasting means re-enacting existing laws together with their amendments • Consolidation means fusing together several laws on the same topic into big long law

16. Codification • In 2001, the Commission announced a codification programme covering all existing EU legislation and involving several hundreds of legal acts. • Codification is carried out in an increasing number of languages on legislation which is at a 'standstill‘ and is not subject to substantial amendments during the codification process. • In 2006, the Commission re-launched a codification programme involving more than 400 laws. By the end of 2008 the Commission had codified 227 of them. Most are now adopted and published in the EU Official Journal. • Codified laws, once translated into all EU languages, are published in the EU Official Journal.

17. Regulations and Directives in the pharma/healthcare sectors • IP protection (eg supplementary protection certificates; paediatric extensions; trade marks; biotech inventions) • Establishment and protection of standards (eg EMA, geographical indications, designations of origin, traditional specialty guaranteed; GM products) • Cosmetics, herbal remedies, food products, ingredients

18. Regulations and Directives thataffect the marks and brands sector • Regulations on Community trade marks and designs, plus implementing Regulations • Trade mark and design harmonisation directives • The .eu and EURid regime • Again: geographical indications, designations of origin, traditional specialty guaranteed • Directive on advertising, be it misleading or unfairly comparative

19. Never mind the wording … • OHIM Boards of Appeal not bound by their President’s statements as to the meaning of the CTM Regulation (THINKPAD/THINK PAD); • National courts not bound by Joint Statements of the Commission and the Council as to what the CTM Regulation (ONEL/OMEL etc); • National courts bound by CJEU and General Court interpretations, but not by OHIM Boards of Appeal — or by each other.

20. Never mind the wording … “Art.5(2) Any Member State may also provide that the proprietor shall be entitled to prevent all third parties not having his consent from using in the course of trade any sign which is identical with, or similar to, the trade mark in relation to goods or services which are not similar to those for which the trade mark is registered, where the latter has a reputation in the Member State and where use of that sign without due cause takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the trade mark”.

21. Never mind the wording … Case C-292/00 Davidoff & Cie SA and another v Gofkid Ltd, 21 March 2002, per Advocate General Jacobs: “The optional protection specified in … 5(2) of … Directive 89/104 … relates only to situations in which the goods or services in question are not similar to those for which the (earlier) trade mark is valid. Where goods or services are similar, the national court must examine, in the light of the Court's case-law concerning the protection enjoyed by marks with a highly distinctive character, whether there exists a likelihood of confusion …. The grounds specified in Article … 5(2) on which such optional protection may be granted are exhaustive and may not be supplemented by national rules protecting well-known marks against later signs which are used or to be used in respect of identical or similar goods or services”.

22. Never mind the wording … Case C-292/00 Davidoff & Cie SA and another v Gofkid Ltd, 9 January 2003 “24 … The Court observes that Article 5(2) of the Directive must not be interpreted solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part. 25. Having regard to the latter aspects, that article cannot be given an interpretation which would lead to well-known marks having less protection where a sign is used for identical or similar goods or services than where a sign is used for non-similar goods or services”.

23. Now, about those bananas … • Commission Regulation (EC) No 2257/94 of 16 September 1994 laying down quality standards for bananas

24. “Sizing is determined by: — the length of the fruit expressed in centimetres and measured along the convex face, from the blossom end to the point where the peduncle joins the crown, — the grade, i.e. the measurement, in millimetres, of the thickness of a transverse section of the fruit between the lateral faces and the middle, perpendicularly to the longitudinal axis. The reference fruit for measurement of the length and grade is: — the median finger on the outer row of the hand, — the finger next to the cut sectioning the hand, on the outer row of the cluster. The minimum length permitted is 14 cm and the minimum grade permitted is 27 mm. As an exception to the third paragraph, bananas produced in Madeira, the Azores, the Algarve, Crete, Lakonia and Cyprus which are less than 14 cm in length may be marketed in the Community but must be classified in Class II.”

25. “Tolerances in respect of quality and size shall be allowed within each package in respect of produce not satisfying the requirements of the class indicated. A. Quality tolerances (i) ‘Extra’ class 5 % by number or weight of bananas not satisfying the requirements for the ‘extra’ class but meeting those for Class I, or, exceptionally, coming within the tolerances for that class. (ii) Class I 10 % by number or weight of bananas not satisfying the requirements of Class I but meeting those for Class II, or, exceptionally, coming within the tolerances for that class. (iii) Class II 10 % by number or weight of bananas satisfying neither the requirements for Class II nor the minimum requirements, with the exception of produce affected by rotting or any other deterioration rendering it unfit for consumption. B. Size tolerances For all classes, 10 % by number of bananas not satisfying the sizing characteristics, up to a limit of 1 cm for the minimum length of 14 cm”.

26. … and a drop of water Commission Regulation (EU) No 1170/2011 of 16 November 2011 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk

27. The excuse? Said the European Food Safety Authority: “On 16 November 2011 the European Commission published the list of health claims made on foods and referring to the reduction of disease risk (EU No 1170/​2011) rejected in previous months by the European Food Safety Authority (EFSA). Among those claims was a claim related to the role of water in the prevention of dehydration filed earlier this year by two German scientists. At the time, the claim had to be rejected by EFSA because it was filed under the wrong legal provision (Article 14 of Regulation 1924/​2006/​EC instead of Article 13). In short, Article 14 deals with diseases and illnesses whereas dehydration was not regarded by EFSA as a disease”.

28. What they said “(1) Pursuant to Regulation (EC) No 1924/​2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims. (6) … the applicant proposed water loss in tissues or reduced water content in tissues as risk factors of dehydration. On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 16 February 2011 that the proposed risk factors are measures of water depletion and thus are measures of the disease. Accordingly, as a risk factor in the development of a disease is not shown to be reduced, the claim does not comply with the requirements of Regulation (EC) No 1924/​2006 and it should not be authorised”

29. But all is not lost … Good news for ugly apricots, artichokes, asparagus, aubergines, avocadoes, beans, Brussels sprouts, carrots, cauliflowers, cherries, courgettes, cucumbers, cultivated mushrooms, garlic, hazelnuts in their shells, headed cabbage, leeks, melons, onions, peas, plums, ribbed celery, spinach, walnuts in their shells, water melons and witloof/chicory …

31. Final thoughts 1 • The Leg-to-Reg system is highly complex and non-intuitive, which reduces input from outsiders and makes stakeholder input difficult to achieve • The system is difficult to control through legislative means, so judicial doctrine is allowed to accrue — whether even if it has no obvious basis in EU legislation

32. Final thoughts 2 • The imbalance of interest, expertise and resources favours the Commission over the Council and the Parliament • The codification of IP Regulations and Directives has been handled insensitively; it is a good idea in theory but a nuisance in practice • There has been insufficient joined-up thinking about areas of intersection and overlap

33. Final thoughts 3 • The scope for divergent interpretations of the CTM Regulation and the Trade Mark Directive remains considerable: is this a good thing, a bad thing — or both?

34. The end