JUDGMENT OF THE COURT
16 December 1999 (1)
(Medicinal products Marketing authorisation Parallel imports)
In Case C-94/98,
REFERENCE to the Court under Article 177 of the EC Treaty (now Article 234EC) by the High Court of Justice of England and Wales, Queen's Bench Division,United Kingdom, for a preliminary ruling in the proceedings pending before thatcourt between
The Queen
and
The Licensing Authority established by the Medicines Act 1968
(represented by the Medicines Control Agency),
ex parte: Rhône-Poulenc Rorer Ltd,
May & Baker Ltd,
on the interpretation of Council Directive 65/65/EEC of 26 January 1965 on theapproximation of provisions laid down by law, regulation or administrative actionrelating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), asamended, in particular, by Council Directive 93/39/EEC of 14 June 1993 (OJ 1993L 214, p. 22), and of the provisions of Community law relating to the grant ofparallel import licences for medicinal products,
THE COURT,
composed of: G.C. Rodríguez Iglesias, President, D.A.O. Edward, L. Sevón,R. Schintgen (Presidents of Chambers), C. Gulmann (Rapporteur), J.-P. Puissochet,G. Hirsch, P. Jann and H. Ragnemalm, Judges,
Advocate General: A. La Pergola,
Registrar: D. Louterman-Hubeau, Principal Administrator,
after considering the written observations submitted on behalf of:
Rhône-Poulenc Rorer Ltd and May & Baker Ltd, by G. Hobbs QC and J.Stratford, Barrister, instructed by R. Freeland and M. Farquharson,Solicitors,
the United Kingdom Government, by J.E. Collins, Assistant TreasurySolicitor, acting as Agent, assisted by R. Drabble QC and P. Saini, Barrister,
the French Government, by K. Rispal-Bellanger, Head of Subdirectorate inthe Legal Affairs Directorate of the Ministry of Foreign Affairs, and R.Loosli-Surrans, Head of Mission in that directorate, acting as Agents,
the Commission of the European Communities, by R.B. Wainwright,Principal Legal Adviser, and H. Støvlbæk, of its Legal Service, acting asAgents,
having regard to the Report for the Hearing,
after hearing the oral observations of Rhône-Poulenc Rorer Ltd and May & BakerLtd, represented by G. Hobbs and J. Stratford, of the United KingdomGovernment, represented by R. Drabble and P. Saini, of the French Government,represented by R. Loosli-Surrans, of the Swedish Government, represented by A.Kruse, Departementsråd in the Legal Affairs Secretariat (EU) of the Ministry ofForeign Affairs, acting as Agent, and of the Commission, represented by R.B.Wainwright and H. Støvlbæk, at the hearing on 9 March 1999,
after hearing the Opinion of the Advocate General at the sitting on 19 May 1999,
gives the following
Judgment
- 1.
- By order of 31 July 1997, received at the Court on 1 April 1998, the High Courtof Justice of England and Wales, Queen's Bench Division, referred to the Court fora preliminary ruling under Article 177 of the EC Treaty (now Article 234 EC) twoquestions on the interpretation of Council Directive 65/65/EEC of 26 January 1965on the approximation of provisions laid down by law, regulation or administrativeaction relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20),as amended, in particular, by Council Directive 93/39/EEC of 14 June 1993 (OJ1993 L 214, p. 22) ('the Directive), and of the provisions of Community lawrelating to the grant of parallel import licences for medicinal products.
- 2.
- Those questions were raised during proceedings between Rhone-Poulenc Rorer Ltd('RPR) and May & Baker Ltd ('M & B), and the Licensing Authorityestablished by the Medicines Act 1968, represented by the Medicines ControlAgency ('the MCA), concerning decisions taken by the MCA on parallel importlicences for a medicinal product called 'Zimovane.
The relevant provisions
- 3.
- Article 30 of the EC Treaty (now, after amendment, Article 28 EC) states thatquantitative restrictions on imports and measures having equivalent effect areprohibited between Member States. However, Article 36 of the EC Treaty (now,after amendment, Article 30 EC) provides that prohibitions and restrictions onimports between Member States which are justified on grounds of, inter alia, theprotection of health of humans are permitted, so long as they do not constitute ameans of arbitrary discrimination or a disguised restriction on trade betweenMember States.
- 4.
- Under Article 3 of the Directive, no medicinal product may be placed on themarket of a Member State unless an authorisation has been issued by thecompetent authorities of that State.
- 5.
- Article 4 of the Directive defines the procedure, documents and informationrequired in order to obtain a marketing authorisation. Under point 3 of Article 4of the Directive, an application for a marketing authorisation must be accompaniedby qualitative and quantitative particulars of all the constituents of the medicinalproduct. Under point 8 of Article 4 of the Directive, the application must be, inparticular, accompanied by the results of physico-chemical, biological ormicrobiological tests, pharmacological and toxicological tests, and clinical trials.Under point 9 of the same article, the application must be accompanied by asummary of the product characteristics and one or more specimens or mock-upsof the sales presentation of the medicinal product. Article 4a of the Directive,which was inserted by Council Directive 83/570/EEC of 26 October 1983 (OJ 1983L 332, p. 1), specifies the information that must be included in the summary of theproduct characteristics.
- 6.
- Article 5 of the Directive provides that the authorisation will be refused if, afterverification of the particulars and documents listed in Article 4, it proves that themedicinal product is harmful in the normal conditions of use, or that its therapeuticefficacy is lacking or is insufficiently substantiated by the applicant, or that itsqualitative and quantitative composition is not as declared.
- 7.
- Article 10 of the Directive provides that authorisation is to be valid for five yearsand is to be renewable for five-year periods after consideration by the competentauthority of a dossier containing details of the data on pharmacovigilance and otherinformation relevant to the monitoring of the medicinal product.
- 8.
- Article 29a of Second Council Directive 75/319/EEC of 20 May 1975 (OJ 1975 L147, p. 13), inserted by Directive 93/39, provides that the Member States are toestablish a pharmacovigilance system which, in particular, imposes obligations onthe holder of the marketing authorisation in respect of recording and reporting alladverse reactions to the medicinal product. Thus, records must be submitted to thecompetent authorities at regular intervals and must be accompanied by a scientificevaluation.
- 9.
- In 1984, on the basis of a Commission communication published on 6 May 1982(OJ 1982 C 115, p. 5), which is based on Case 104/75 De Peijper [1976] ECR 613,the MCA issued a document entitled 'Notes on Application for Product Licences(Parallel Importing) (Medicines for Human Use) ('MAL 2 (PI)).
- 10.
- An import of medicinal products is treated as a 'parallel import for the purposeof MAL 2 (PI) where a product is the subject of a United Kingdom marketingauthorisation and an applicant wishes to import from the European Community aversion of that product which already has a marketing authorisation issued byanother Member State. In accordance with MAL 2 (PI), applications for parallelimport licences are examined and assessed according to a 'simplified procedureunder which the applicant needs to provide less information than is required for anapplication for a marketing authorisation made in accordance with the Directive.
- 11.
- Paragraph 4 of MAL 2 (PI) provides that:
'All the following conditions must be met before an application can be consideredunder these arrangements i.e. the product concerned must be
(a) A product which is to be imported from a Member State of the EuropeanCommunity;
(b) a proprietary medicinal product (as defined in Article 1 of EC Directive65/65) for human use ...;
(c) covered by a currently valid marketing authorisation granted, in accordancewith Article 3 of EC Directive 65/65, by the regulatory authority of an ECMember State;
(d) ... have no differences, having therapeutic effect, from a product covered bya UK product licence (PL) ...;
(e) made by, or under licence to:
(i) the manufacturer who made the product covered by the UK productlicence or;
(ii) a member of the same group of companies as the manufacturer whomade the product covered by the UK product licence.
If any of these conditions is not met the applicant will be invited to apply for a PLin the normal way under the MAL 2 procedures.
- 12.
- Paragraph 12 of MAL 2 (PI) provides that an authorisation for parallel importscontinues in force only so long as both the United Kingdom licence and theCommunity marketing authorisation to which it relates are in force. If either ceasesto be valid for any reason (for example, through expiry or revocation) the parallelimport licence also ceases to be valid.
- 13.
- Paragraph 21 of MAL 2 (PI) provides that the normal arrangements apply withregard to variations to a parallel import licence made at the request of the licenceholder. The licensing authority needs to ensure that the licence is kept in line withthe relevant provisions of the appropriate product licence. The licensing authoritywill notify the parallel import licence holder of any action necessary as the resultof a variation to the United Kingdom product licence. The parallel import licenceholder is required to notify the licensing authority of any variation to theCommunity marketing authorisation that comes to his attention. He must seekapproval to market the varied product by asking for a variation to that parallelimport licence. No batch of a varied product may be marketed in the UnitedKingdom until the variation has been approved by the licensing authority.
The main proceedings
- 14.
- In 1989 and 1993, M & B, a member of a group of companies which operate in theresearch-based pharmaceutical industry, obtained marketing authorisations issuedby the MCA covering various forms of tablets and capsules of the product called'Zimovane, which is used for the treatment of insomnia and whose generic nameis zopiclone. M & B appointed RPR as its agent to manufacture and market thatproduct.
- 15.
- After more than three years of research, RPR developed a new version ofZimovane. It contains the same active ingredients and has the same therapeuticeffect as the old version, but is manufactured by a different manufacturing processand using different excipients which provide a particular benefit to public healthcompared with the old version of Zimovane.
- 16.
- RPR submitted the required relevant data to the MCA in order to establish thesafety, efficacy and quality of the new version and, on 11 July 1996, the MCAgranted a variation to some of the existing marketing authorisations relating toZimovane. The variations allow RPR to market its new version of Zimovane in theUnited Kingdom. On 31 July 1996, at the request of RPR, the MCA revoked theauthorisations under which the old version of Zimovane had been marketed.
- 17.
- Accordingly, RPR has no longer marketed the old version of Zimovane in theUnited Kingdom. However, RPR continued to market that version of Zimovane inthe other Member States, its new version only being marketed in the UnitedKingdom.
- 18.
- Before the authorisations relating to the old version of Zimovane were revoked,parallel import licences for that version were granted to several companies, inaccordance with MAL 2 (PI). When the parent authorisation upon which theydepended was revoked by the MCA, they lapsed under paragraph 12 of MAL 2(PI). The holders of the parallel import licences were informed by the MCA that,if they wished to maintain their licences, they had to apply for variations to thoselicences in order to determine a new appropriate reference product. Afterexamining the applications made to this effect, the MCA, by a number of decisionstaken between November 1996 and May 1997, decided to treat the parallel importlicences as still valid, those licences then being appended to the marketingauthorisation issued for the new version of Zimovane. The MCA also, with effectfrom 1 August 1996, issued three new parallel import licences for the old versionof Zimovane.
- 19.
- On 14 February and 5 June 1997, M & B and RPR lodged applications for judicialreview of the MCA's decisions claiming that, in the absence of any subsistingmarketing authorisations for the old version of Zimovane in the United Kingdom,imports of that version into the United Kingdom were not parallel imports, so itwas contrary both to the legislation applicable in the United Kingdom and toCommunity law to treat them as such.
- 20.
- During those proceedings, the MCA contended, in particular, that had it treatedthe two versions of Zimovane as different products and required the parallelimporters of the old version of that product to apply for marketing authorisationsunder the Directive, it would have created an unjustifiable restriction on importscontrary to Article 30 of the Treaty.
- 21.
- In those circumstances, the national court decided to stay proceedings and to referthe following questions to the Court for a preliminary ruling:
'1. In a case where medicinal product X is sought to be imported fromMember State A into Member State B, is it permissible for the person whoproposes to place the imported product upon the market in Member StateB to seek and obtain a marketing authorisation from the competentauthority in Member State B without complying with the requirements ofCouncil Directive 65/65/EEC (as amended) if:
(a) medicinal product X is the subject of a marketing authorisationgranted in Member State A and was the subject of a marketingauthorisation which has ceased to have effect in Member State B; and
(b) medicinal product X has the same active ingredients and therapeuticeffect as medicinal product Y, but is not manufactured according tothe same formulation as medicinal product Y; and
(c) medicinal product Y is the subject of a marketing authorisationgranted in Member State B, but is not the subject of a marketingauthorisation granted in Member State A; and
(d) the marketing authorisations referred to in (a) and (c) above weregranted to different members of the same group of companies and themanufacturers of medicinal products X and Y are also members ofthat group of companies; and
(e) companies within the same group as the holder of the marketingauthorisation for product X continue to manufacture and marketproduct X in Member States other than Member State B?
2. To what extent is it relevant to the answer to Question 1 that:
(a) the marketing authorisation for medicinal product X ceased to haveeffect in Member State B as a result of voluntary surrender on thepart of the person to whom it had been granted; and/or
(b) the formulation of medicinal product Y was developed and introducedin order to provide a benefit to public health which medicinal productX (manufactured according to a different formulation) does notprovide; and/or
(c) that benefit to public health would not be achieved if product X andproduct Y are both on the market in Member State B at the sametime; and/or
(d) the differences between the formulations of medicinal product X andmedicinal product Y are such that neither product may lawfully bemarketed under the marketing authorisation applicable to the other;and/or
(e) the competent authority possesses the relevant data required underDirective 65/65 in relation to both product X and product Y; and/or
(f) the competent authority considers that the prohibition on imports ofproduct X from Member State A would have the effect of partitioningthe market; and/or
(g) the competent authority considers that there are no grounds within
Article 36 of the EC Treaty which would justify a prohibition onimports and sales of product X?
The questions referred for a preliminary ruling
- 22.
- In order to answer the questions referred for a preliminary ruling, which may beexamined together, it is necessary to ascertain whether imports of the old versionof Zimovane may in fact be treated as parallel imports, in which case the normalprocedure under the Directive relating to the issue of marketing authorisations doesnot apply.
- 23.
- The first point to note is that notwithstanding the Treaty rules on the freemovement of goods no medicinal product may be placed on the market in aMember State unless a marketing authorisation has been issued in accordance withthe Directive by the competent authority of that State. An application for amarketing authorisation for a medicinal product submitted by the personresponsible for placing it on the market must contain the information and beaccompanied by the documents listed in Article 4 of the Directive even where themedicinal product concerned is already the subject of an authorisation issued by thecompetent authority of another Member State.
- 24.
- However, those principles are subject to exceptions arising, on the one hand, fromthe Directive itself and, on the other, from the Treaty rules relating to the freemovement of goods.
- 25.
- Accordingly, point 8 of Article 4 of Directive 65/65/EEC, as amended by CouncilDirective 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36), establishes an'abridged procedure which, subject to certain conditions, relieves themanufacturers of medicinal products which are essentially similar to medicinalproducts already authorised from having to provide the results of pharmacologicaland toxicological tests and of clinical trials, thus saving the time and expensenecessary to assemble such data, and avoiding the repetition of tests on humans or
animals where these are not absolutely necessary (see Case C-368/96 Generics (UK)and Others [1998] ECR I-7967, paragraphs 2 to 4).
- 26.
- The other exception, which is relevant in this case, is defined in De Peijper. In thatcase, the Court held, at paragraphs 21 and 36, in the context of Articles 30 and 36of the Treaty, that if, as a result of importation on a previous occasion which gaverise to the grant, by them, of a marketing authorisation, the public healthauthorities of the Member State of importation are already in possession of all theparticulars necessary for checking that the product is effective and safe, it is notnecessary, for the purpose of protecting the health and life of humans, for thoseauthorities to require a second trader who has imported a medicinal product whichis in every respect the same or which has no differences altering the therapeuticeffect, to submit the abovementioned particulars to them again.
- 27.
- In Case C-201/94 Smith & Nephew and Primecrown [1996] ECR I-5819, paragraph21, the Court stated again that the Directive cannot apply to a medicinal productcovered by a marketing authorisation in one Member State which is being importedinto another Member State as a parallel import of a product already covered bya marketing authorisation in that other Member State, because the importedmedicinal product cannot, in such a case, be regarded as being placed on themarket for the first time in the Member State of importation.
- 28.
- The Court went on to state, in paragraphs 25 and 26 of that judgment, that inorder to ascertain whether imports of a medicinal product constitute parallelimports the competent authority in the Member State of importation must verifythat the two medicinal products have a common origin and, if not identical in allrespects, have at least been manufactured according to the same formulation, usingthe same active ingredient, and have the same therapeutic effect.
- 29.
- In the light of that case-law, it is important to note that in the present case it iscommon ground that the medicinal products at issue in the main proceedingscontain the same active ingredients and have the same therapeutic effect and acommon origin, since they come from manufacturers belonging to the same groupof companies.
- 30.
- However, it is clear from the observations submitted to the Court that there areother particular circumstances of the case which might cast doubt on thecompliance with Community law of the decisions of the United Kingdom authoritiesat issue.
- 31.
- M & B and RPR claim that the provisions of Community law relating to theparallel importation of medicinal products apply only for so long as the productconcerned is covered by marketing authorisations which are simultaneously in forcein the Member State of exportation and the Member State of importation. In thiscase, it would therefore have been unlawful to apply the procedure set out in MAL
2 (PI) with a view to authorising imports into the United Kingdom of the oldversion of Zimovane. First, the parent authorisation of the old version of themedicinal product was revoked and, second, the condition established by the Courtin Smith & Nephew and Primecrown of 'manufacture according to the sameformulation was not met. According to M & B and RPR, this latter conditionincludes both active ingredients and excipients. They add that their decision todistribute only the new version of Zimovane in the United Kingdom and tosurrender the authorisations relating to the old version is explained by the need toachieve, primarily in that Member State, a particular benefit for public health abenefit which could not be achieved if the old and new versions of the productwere both available on the United Kingdom market at the same time.
- 32.
- The French Government observes that, even if the excipient is not relevant to thetherapeutic effect, it is considered to be a part of the qualitative and quantitativeparticulars of the product as referred to in the Directive, since it is part of theformulation of the product. Therefore, unless a new marketing authorisation isobtained in accordance with the provisions of the Directive, imports of the oldversion of Zimovane cannot be treated as parallel imports within the meaning ofthe case-law of the Court.
- 33.
- The Commission observes that, according to Articles 3 and 4 of the Directive,marketing authorisations are given for a specific medicinal product, which has beenevaluated by means of a stringent authorisation procedure, taking into account theproduct as a whole, including the excipients. The composition of a medicinalproduct includes both the active ingredients and the excipients. All the constituentsof a medicinal product are of importance to the quality, efficacy and safety of theproduct and form part of the summary of product characteristics of a medicinalproduct required by Article 4a of the Directive. That summary is an integral partof the authorisation for any medicinal product. In this case, the differences betweenthe old and new versions are therefore not without importance. The Commissionadds that, if the marketing authorisation for a medicinal product is revoked, thereis no obligation to submit information regularly in connection with renewal of theauthorisation, in accordance with the pharmacovigilance system established byDirective 75/319. As a result, the competent authorities in the State of importationcannot be sure that the use of the old product imported in parallel is still safe,according to the latest scientific data.
- 34.
- According to the United Kingdom Government, in circumstances such as those ofthis case, the MCA is required, under Article 30 of the Treaty, to allow parallelimports of the old version of Zimovane onto the United Kingdom market. Thereis no reason to treat the two versions of the product as different medicinalproducts. That would require parallel importers of the old version of Zimovane toobtain a marketing authorisation within the meaning of the Directive, if indeed thatwere actually possible (given the insuperable difficulty of repeating the chemical,pharmaceutical and biological tests required by the Directive). The old and newproducts are, from the therapeutic point of view, in normal conditions of use,
equivalent versions of a product with a common origin and the same activeingredient. Changes in the excipients of a medicinal product do not, in general,alter the therapeutic effect.
- 35.
- Whilst acknowledging that RPR did not consciously attempt to isolate the UnitedKingdom market from the rest of the Community market, the United KingdomGovernment observes that, if RPR's arguments were accepted, the voluntarysurrender of the marketing authorisation for the old version of Zimovane wouldhave precisely the effect of thus partitioning the market. Notwithstanding theformal revocation of the parent authorisation, the MCA is in possession of all thedata, documents and details required by Article 4 of the Directive for the purposeof monitoring the efficacy and safety of the medicinal product which is to be thesubject of a parallel importation. It is also in a position, in the future, by virtue ofthe rules that exist in relation to pharmacovigilance, to acquire the informationneeded to be sure that the old version of Zimovane does not pose a problem forpublic health, so long as there are marketing authorisations in other MemberStates.
- 36.
- The United Kingdom Government observes, finally, that the general interest insafeguarding public health, even if it were understood in the sense relied upon byM & B and RPR, does not require a measure such as a complete ban on parallelimports of the old version of the product.
- 37.
- The Swedish Government submits that the two versions of Zimovane aresufficiently alike for them to be treated as the same product. If the obligation forthe formulation to be identical were to be understood as meaning the wholeformulation of the medicinal products, this would create unjustified obstacles tointra-Community trade.
- 38.
- It appears, therefore, that the criticism of the contested decisions of the UnitedKingdom authorities is based, in particular, on the fact that those decisions couldbe contrary to Community law for the following three reasons:
the two versions of Zimovane are not manufactured according to the sameformulation, the new version being manufactured using different excipientsand by a different manufacturing process;
the pharmacovigilance system will not work because after the parentmarketing authorisation is revoked the holder of the marketingauthorisation is no longer obliged to submit information regularly in relationto the old version of the medicinal product; and
the particular benefit for public health which is provided by the new versionof Zimovane as compared with the old version could not be achieved if the
old and new versions of the medicinal product were both available on theUnited Kingdom market at the same time.
- 39.
- Before examining each of those three grounds for criticising the parallel importlicences at issue, it is important to note that it is not necessary to rule on thequestion of lawfulness in the light of the free movement of goods of the automaticrevocation of parallel import licences as a result of the revocation of a parentauthorisation at the request of the holder of that authorisation. That question doesnot arise in this case because the United Kingdom authorities have acknowledgedthat the parallel import licences for the old version of Zimovane are appended tothe marketing authorisation issued for the new version.
- 40.
- Next, it should be noted that although, as the Court held in De Peijper and Smith& Nephew and Primecrown, it follows from Articles 30 and 36 of the Treaty that national authorities must not obstruct parallel imports by requiring parallelimporters to satisfy the same requirements as those which are applicable toundertakings applying for the first time for a marketing authorisation for amedicinal product, that principle is subject to the condition that an exception ofthat kind to the rules normally applicable to marketing authorisations for medicinalproducts does not undermine the protection of public health. As is clear from thefirst recital in the preamble to the Directive, the primary purpose of any rulesconcerning the production and distribution of medicinal products must be tosafeguard public health. The criteria which must be met by a product imported asa parallel import for the parallel importer to be under no obligation to supply theparticulars referred to in the Directive must not, therefore, lead to a relaxation ofsafety requirements (see, to that effect, Generics (UK), paragraph 22).
- 41.
- It must also be borne in mind that there would be a real obstacle to intra-Community trade if importers of the old version of Zimovane, which is stillauthorised in other Member States and lawfully marketed there, were not able touse the simplified procedure open to parallel importers in accordance with MAL2 (PI).
- 42.
- As is clear from paragraph 35 of this judgment, the competent authorities in theUnited Kingdom considered it possible to authorise the placing on the market ofthose medicinal products imported as parallel imports by using as a parentmarketing authorisation the authorisation for the new version of Zimovane andthey have taken the view that, on the basis of the information in their possession,in spite of the different excipients used, the old version of Zimovane clearlyremained effective and safe.
- 43.
- Although, as the United Kingdom Government has submitted, differences in theexcipients used in medicinal products do not normally have any effect on safety, itis not disputed that such effects can exist. It is possible for a medicinal productimported as a parallel import, which contains the same active ingredients and hasthe same therapeutic effect but does not use the same excipients as the medicinal
product which is the subject of the marketing authorisation in the Member Stateof importation, to show significant differences from the authorised product in termsof safety, given that modifications to the formulation of a medicinal product inrespect of the excipients may have an effect on the shelf-life and the bioavailabilityof the product, for example in relation to the rates at which the medicinal productdissolves or is absorbed (see also, to that effect, Generics (UK), paragraph 32).
- 44.
- However, the possibility of such effects on safety does not mean that as aconsequence of differences relating to the excipients used the national authoritiesmay never resort to simplified procedures for the licences granted to parallelimporters.
- 45.
- The national authorities are required to authorise, in accordance with the rulesrelating to parallel imports, a medicinal product imported as a parallel productwhere they are convinced that that product, in spite of differences relating to theexcipients, does not pose a problem for public health. Accordingly, the competentauthorities of the Member State of importation must ensure, at the time of importand on the basis of information in their possession, that the medicinal productimported as a parallel product, even if not identical in all respects to that alreadyauthorised by them, has the same active ingredient and the same therapeutic effectand does not pose a problem of quality, efficacy or safety (see, to that effect, CaseC-100/96 British Agrochemicals Association [1999] ECR I-1499, paragraph 40).
- 46.
- As regards the problem raised in relation to pharmacovigilance, it is sufficient thatpharmacovigilance satisfying the relevant requirements of Directive 75/319 asamended can be ensured for medicinal products imported as parallel imports, likethose in this case, through cooperation with the national authorities of the otherMember States by means of access to the documents and data, produced by themanufacturer or other companies in the same group, relating to the old version inthe Member States in which that version is still marketed on the basis of amarketing authorisation still in force. In addition, it is possible to compel the holderof the marketing authorisation in the Member State of importation, who belongsto the group of companies which is in possession of the marketing authorisationsfor the old version in the other Member States, to supply the necessary information(see, to that effect, De Peijper, paragraphs 26 and 27).
- 47.
- Finally, it is necessary to examine the argument put forward by M & B and RPRthat the particular benefit to public health provided by the new version ofZimovane as compared with the old version would not be achieved if the oldversion of Zimovane were present on the United Kingdom market. In that regard,it is sufficient to state that, even if the argument were well founded, it does notfollow that, in circumstances such as those of the main case, the national authoritiesare compelled to require parallel importers to follow the procedure laid down inthe Directive if they take the view that, in normal conditions of use, as referred to
in Article 5 of the Directive, the medicinal product imported as a parallel importdoes not pose a risk as to quality, efficacy or safety.
- 48.
- In the light of the foregoing, the answer to the questions referred for a preliminaryruling must be that where it is sought to import medicinal product X from MemberState A into Member State B, it is permissible for the person who proposes toplace the imported product upon the market in Member State B to seek andobtain a parallel import licence from the competent authority in Member State Bwithout complying with all the requirements of the Directive if:
medicinal product X is the subject of a marketing authorisation granted inMember State A and was the subject of a marketing authorisation which hasceased to have effect in Member State B;
medicinal product Y is the subject of a marketing authorisation granted inMember State B, but is not the subject of a marketing authorisation grantedin Member State A;
medicinal product X has the same active ingredients and therapeutic effectas medicinal product Y, but does not use the same excipients and ismanufactured by a different manufacturing process, where the competentauthority in Member State B is in a position to verify that medicinal productX complies with the requirements relating to quality, efficacy and safety innormal conditions of use and is in a position to ensure normalpharmacovigilance;
the marketing authorisations referred to above were granted to differentmembers of the same group of companies and the manufacturers ofmedicinal products X and Y are also members of that group of companies;and
companies within the same group as the holder of the marketingauthorisation for product X which has been withdrawn in Member State Bcontinue to manufacture and market product X in Member States otherthan Member State B.
In such a situation, the competent authority is not required to take intoconsideration the fact that medicinal product Y was developed and introduced inorder to provide a particular benefit to public health which medicinal product Xdoes not provide and/or that that particular benefit to public health would not beachieved if product X and product Y were both on the market in Member StateB at the same time.
Costs
- 49.
- The costs incurred by the United Kingdom, French and Swedish Governments andby the Commission, which have submitted observations to the Court, are notrecoverable. Since these proceedings are, for the parties to the main proceedings,a step in the proceedings pending before the national court, the decision on costsis a matter for that court.
On those grounds,
THE COURT,
in answer to the questions referred to it by the High Court of Justice of England& Wales, Queen's Bench Division, by order of 31 July 1997, hereby rules:
Where it is sought to import medicinal product X from Member State A intoMember State B, it is permissible for the person who proposes to place theimported product upon the market in Member State B to seek and obtain aparallel import licence from the competent authority in Member State B withoutcomplying with all the requirements of Council Directive 65/65/EEC of 26 January1965 on the approximation of provisions laid down by law, regulation oradministrative action relating to medicinal products (OJ, English Special Edition1965-1966, p. 20), as amended by Council Directive 93/39/EEC of 14 June 1993, if:
medicinal product X is the subject of a marketing authorisation granted inMember State A and was the subject of a marketing authorisation whichhas ceased to have effect in Member State B;
medicinal product Y is the subject of a marketing authorisation granted inMember State B, but is not the subject of a marketing authorisationgranted in Member State A;
medicinal product X has the same active ingredients and therapeutic effectas medicinal product Y, but does not use the same excipients and ismanufactured by a different manufacturing process, where the competentauthority in Member State B is in a position to verify that medicinalproduct X complies with the requirements relating to quality, efficacy andsafety in normal conditions of use and is in a position to ensure normalpharmacovigilance;
the marketing authorisations referred to above were granted to differentmembers of the same group of companies and the manufacturers ofmedicinal products X and Y are also members of that group of companies;and
companies within the same group as the holder of the marketingauthorisation for product X which has been withdrawn in Member State Bcontinue to manufacture and market product X in Member States otherthan Member State B.
In such a situation, the competent authority is not required to take intoconsideration the fact that medicinal product Y was developed and introduced inorder to provide a particular benefit to public health which medicinal product Xdoes not provide and/or that that particular benefit to public health would not beachieved if product X and product Y were both on the market in Member State Bat the same time.
Rodríguez Iglesias EdwardSevón Schintgen GulmannPuissochet Hirsch JannRagnemalm |
Delivered in open court in Luxembourg on 16 December 1999.
R. Grass
G.C. Rodríguez Iglesias
Registrar
President