1 Users distributors and producers of PPP

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Users, distributors and producers of PPP in the context of parallel trade : • The limits of the « Kohlpharma » case • The parallel import within the framework of the concept of zonal marketing authorization (MA) and mutual recognition 2

a view point 3

another view point 4

EU Treaty • Articles 28 – 30 In the absence of harmonisation, [case 12/00] « the Commission considers that … any measures which restrict the free movement of products … must be assessed in the light of Article 30 of the Treaty. » Furthermore, « the Court has consistently held that a rule of secondary legislation, …, cannot be interpreted as authorising the Member States to impose or to maintain conditions contrary to the Treaty rules on the free movement of goods (Case C-47/90 Delhaize et Le Lion [1992] ECR I-3669, paragraph 26; Case C-315/92 Verband Sozialer Wettbewerb [1994] ECR I 317, Clinique, paragraph 12; and Joined Cases C-427/93, C-429/93 and C -436/93 Bristol-Myers Squibb and Others [1996] ECR I-3457, paragraph 27). » 5

Case law But more than 30 years of endless discussion : « Sometimes I think the law may be losing a sense of reality in this area – we are, after all, only considering the use of the owner’s trade mark for his goods in perfect condition. The pickle the law has got into would, I think, astonish the average consumer. » Lord Justice Jacob, the Court of Appeal (England Wales) (Civil Division) seeks further guidance from the Court of Justice on the effect of the latter’s judgment in Boehringer Ingelheim and Others 6

Case law • C-100/96, British Agrochemical • approval will only be given when the material to be imported is found by the competent authority to be as safe and efficacious as the member State of importation’s master product … and therefore to be ‘identical’ within the meaning of case 100/96 7

France • After a year investigating the complaint submitted by the President of AUDACE to DG XV, the Commission notified the French Republic and gave notice to comply before 31/08/1998 8

France • FRENCH DECREE No. 2001 -317 of 4 April 2001 establishing a simplified procedure for the marketing authorisation of pesticides originating from the European Economic Area 9

Abuse • Abuse of the new law from the onset • First victim, a French generic producer of a registration granted in March 2000 10

AUDACE’s actions against abuses since 2001 • towards its members • towards the national competent authorities • towards the community competent authorities • towards the dominant industry 11

AUDACE’s propositions before the working group • accreditation compulsory to all involved in the distribution of every classes of PPP, registration holders and advisers • accreditation number on all invoices with the products’ MA numbers 12

Proposed measures • advantages • legal responsibility for those qualified people who backed the accreditation • loss of accreditation when • selling a PPP in conditions differing from the terms of the MA • selling a PPP without a registration • make it an offence for a user to buy PPPs from a nonaccredited source • loss of accreditation leads to loss of MA 13

Proposed measures • objectivity of the regulation since • the user, in whose interest accreditation of the supply chain is made compulsory, is directly involved, and will request that his supplier is accredited • measure applicable to ALL market operators • notification to the Commission under directive 98/34/EC 14

Complete repackaging • legal, with the aim to • gain effective access to the relevant market in the face of • lack of relevant container size • customer resistance to over-sticking • protect sources • promote the importer’s own trade marks 15

Complete repackaging • this situation in law implies • preserving the integrity of the product • ensuring the possibility to trace the product • compliance with the terms of its MA 16

Integrity Complete repackaging poses the most serious threat to health, safety and the environment and must be controlled by public authorities • as part of the application for MA, it must be specifically requested and motivated • repacking unit authorised by the authorities • MA made conditional of compliance for its duration • importer is made responsible for the integrity of the completely repackaged product 17

Tracing • keep for 5 years relevant data relating to repackaging operations • tracing, correlation with original production dates and lot numbers • allow for spot checks by the authorities at 48 or 72 hours notice (phone and fax) • notification to the authorities prior to any repackaging operations 18

Compliance • the importer keeps records of quantities put on the market every year • he informs his customer that the product has been repackaged • as part of the invoice to a distributor, mandatory declaration by the MA holder that the PPP complies with the terms of its MA and that he ensures tracing back to the originator product • invoices send by distributors to the local competent authorities within 30 days 19

KOHLPHARMA There are limits to the principal of parallel import with Kohlpharma, those limits have been pushed back and this is logical 20

KOHLPHARMA • The stubborn refusal to consider the community MA is the cause of much complexity • Showing dogged determination not to implement mutual recognition did not help • The principles of proportionality, objectivity and necessity have made the rest… 21

KOHLPHARMA The limits of Kohlpharma • It relates exclusively to a generic PPP already assessed in relation to the same master product in another member State • It does not give support to fraudulent practices • The use of the MA is strictly limited by the terms under which the PPP has been authorised 22

France • Community law (C-112/02 of 01 April 2004) does not allow for a MA application to be rejected on the ground that the imported product and the master product do not share a common origin. • The French Decree 2001/317 of 04 April 2001 referring to the British Agrochemicals case requires the common origin of PPP 23

France • France took Kohlpharma into account and revised its regulation relating to pharmaceuticals • Decree 2006 -45 of 12 January 2006 introduced changes to articles R 5121 -115 of CSP deleting the words « à la condition que les deux spécialités soient fabriquées par des entreprises ayant un lien juridique de nature à garantir leur origine commune. » • C-114/04 of 14 July 2005 (points 27 -28) makes it clear that the right at stake is the same for plant protection products or pharmaceuticals referring specifically to parallel imports 24

Identity • C-100/96 • similarity, in the context of essential requirements • information from • the master product MA holder • master product original application dossier • dossier in the member State of origin 25

Identity • Kolpharma • a common origin or, • a MA in the member State of origin 26

Identity • Directive 91/414/EEC articles 10 11 and 19 lay down the general principal that a product produced by the same producer must be authorised by every member State failing what motivations must be given to the Commission and the other member States 27

Resulting proposition 1. systematic consultation of master product MA holder to inform on identity 2. since they have no interest in parallel imports, the identity so established may be taken as sufficient 3. non-identity so established must be supported with evidence and objective motivations for the said differences 4. lack of identity resulting from a formulation less respectful of the essential requirements with no objective motivation relating to the conditions of use MUST lead to questioning the validity of the undesirable MA 28

Resulting proposition 5. recourse to dossiers from the member State of origin is necessary only in the two hypothesis above 6. a motivated refusal of a MA for a parallel import IS NOTIFIED to the community authorities in accordance with directive 94/414/EEC or decision 3052/95/EEC 7. master product MA holders have access to applications and official document of authorisation for a parallel import and can oppose it in case of objective motivation relating for instance to the lack of identity plainly justified or in case the PPP has never been marketed in the member State of origin 29

Resulting proposition 8. in the absence of a common origin, recourse to dossiers from the member State of origin remains the priority 9. the official registration document includes the exhaustive list of conditions under which the authorisation was given • • • trade name attached to the MA trade name of the master product and identification of the MA holder trade name of the imported product and identification of the MA holder in the country of origin precise identification of composition and formulation mention of whether a complete repackaging is authorised or not 30

Parallel imports irritate but are useful In the absence of community MA they contribute to harmonising the single market in accordance with the objectives laid down in the directive(1) yet they must operate within applicable laws and regulations Commission Decision 93/554/EEC of 22 June 1993 case Zera/Montedison 31

Own use parallel imports Time permitting • Montpellier Appeal Court, judgment 617 of 24 May 2006 Questions referred to the ECJ 32