In 1997, the European Council decided to open accession negotiations with 6 countries: Hungary, Poland, Czech Republic, Estonia, Slovenia and Cyprus. Two years later, in December 1999, it was decided to put all 12 candidate countries on an equal footing as negotiating candidates for a full Membership. The Council hence formally opened accession negotiations with the other six candidate countries - Romania, Bulgaria, Lithuania, Latvia, Slovakia and Malta - on 15 February 2000. And in the event, negotiations with some of the second round candidates have progressed to almost the same stage as those with some of the earlier ones.

There is a degree of concern and also of confusion over the current status of pharmaceutical and regulatory data protection in the candidate countries of Central and Eastern Europe (“CEE”), and beyond this, how any disparity between the standards of protection in those countries and the standards being applied by the existing Member States may affect the pharmaceutical industry when, eventually, the candidates do accede to the European Union. This paper looks first at the standards of protection which the majority of the candidate countries are already bound to implement and apply by virtue of their membership of the World Trade Organisation and the regime imposed by its Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPs”)[1], which is now fully in force in all signatories save for the elast-developed countries such as Bangladesh. Secondly, it reviews what is happening in the enlargement negotiations and how the protection regime is likely to look at the end of it.

Patent protection under TRIPs

TRIPs, in force since the start of 1996, has affected the pharmaceutical industry more than any other. This is because this industry is almost unique in having a clearly differentiated generic sector (even if some of this is in common ownership with research companies), the members of which await with eager anticipation the expiry of patent protection on leading drugs. The strategies adopted by the research based companies in the industry to make this transition as difficult as possible for those in the generic sector are many and varied. The TRIPs Agreement brought a substantial degree of harmonisation to intellectual property protection worldwide, and did so in the context of a system which, unlike the Paris Convention, has real powers of enforcement. Those powers are, however, limited to actions being brought by the state against another state - the private sector cannot invoke a Dispute Panel without the adoption of the claim by its government. Nevertheless, the prospect of a claim being brought, and the ultimate possibility of economic sanctions for failure to bring national laws into compliance, has meant that despite a very limited number of cases actually being brought, most national governments have tried very hard to bring their laws into line.

At least partially as a result of TRIPs, most major markets now have well developed patent laws which restrict the introduction of generic products before the expiry of New Chemical Entity (“NCE”) patents, or patents on formulations and uses, in such countries. Even after expiry of the main NCE patent, those to formulations and uses may provide barriers to entry (although those to formulations can often be overcome with obviousness arguments (for example in the UK in recent years in Richardson Vicks’ Patents[2] and Beecham Group’s Patent[3]), and the effectiveness of the barrier provided by those as to “new” uses is only now starting to be tested but is not doing well so far.[4])

Process patents have been available in a wider range of countries for a longer time, since patent laws originally evolved to protect, in the words of the UK’s 1624 Statute of Monopolies, “any manner of new manufacture”.[5] But process patents are perceived to provide a less evident barrier to entry - one might at first sight imagine that one can evade their effect by conducting a process in country where there is no patent protection for that process and then importing the product into a country where the process is protected. That is not the case, as mandated by TRIPs, once again most major markets have laws which make it an infringement to import the product of a process which, if carried out in that country would infringe a patent in that country. Article 28(b) of TRIPs obliges signatories to confer on the owner of a patent the exclusive right:

“Where the subject matter of a patent is a process, to prevent third parties not having the owner’s consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.”

This has long been the law in Europe anyway. Of course, there remains the difficulty of proving that the product was made by the infringing process, but Article 34(1) of TRIPs also requires signatories to reverse the burden of proof on this point, so it is for the importer to prove that they made the product by some other process - not always that easy.

Current status of patent protection for pharmaceuticals in the CEE candidate countries

As can be seen from Table 1, the candidate countries all introduced product patent protection between 1991 and 1994. Of course, this is not seen as adequate by the pharmaceutical industry since many products patented in the rest of Europe between 1976 and 1991, over which patents or Supplementary Protection Certificates are still in force, were not patentable at the time in these countries, and by virtue of their subsequent publication were no longer patentable by the time product patents became available. In consequence, some of the highest earning drugs in the European Union could be completely unprotected in the CEE countries. The research-based industry has applied substantial pressure for the introduction of so-called ‘pipeline protection’, a form of administrative protection which it is argued should be made available for products which were patented elsewhere. The CEE countries’ responses have been varied: in some cases pipeline protection in line with the industry’s demands has been introduced, in others an administrative window was held open for applications for such protection for only a limited period, and in others no additional protection has been made available.

Table 1 [6]

Country Product protection from: Pipeline protection Process protection
Bulgaria 1991 Yes Yes
Czech Republic 1991 Yes Yes
Estonia 1994 Yes
Hungary 1994 Yes, for products patented abroad with priority after 1/87, but only available until 1995 Yes
Latvia 1993 Yes Yes
Lithuania 1994 Yes Yes
Poland 1993 Some Yes
Romania 1992 (excluding second medical use claims) Yes but only if patentee applied in 1998 Yes
Slovakia 1991 Yes Yes
Slovenia 1992 Yes

As a result, the research based industry is still fairly unhappy with the protection which has been provided, but effectively as time goes by the reality of product protection in the candidate countries is going to render those objections obsolete. Unless accessions really do start in 2003, the current nominal target date for the earliest accessions - which, however, seems unlikely at this stage to be met - all of the candidates will have had product protection for more than a decade before they join.

TRIPs also mandates, as to patents:

  • a common minimum patent term of 20 years from filing;
  • limitations on scope for compulsory licences - which is intended to prohibit discrimination in favour of local manufacture. Of course, discrimination can take many forms, including the ease with which product registration applications from one manufacturer pass through the relevant authority’s hands compared to those from another, and such unofficial de facto discrimination can be harder to establish and challenge than a form which is enshrined in law. Nevertheless, the legal principles are laid down.

Regulatory data protection under TRIPs[7]

The importance of data exclusivity in the pharmaceutical industry and a recognition of its "coming of age" as a sui generis type of intellectual property right which is internationally understood has been recognised in a separate TRIPs provision, in Article 39.3. As is only to be expected of a right which has only recently developed, and is only now starting to be analysed in greater detail, at the time when TRIPs was under negotiation there was considerable variation internationally in the protection afforded regulatory data. For example, in the USA protection is provided for 5 years for a new chemical entity product but only 3 years for data relating to a new indication for an existing product and only 6 months for paediatric indications. Australia, Canada and New Zealand give 5 years protection, but only for NCEs. And within Europe, some Member States provide 6 and others 10 years’ protection. As a result, TRIPs leaves much unsaid, leaving much latitude for variations in its implementation nationally, although it is to be expected that subsequent rounds of discussions as to TRIPs may impose more specific criteria, in accordance with developing international norms. Article 39.3, together with Article 39.1 (with which it should be read), sets certain minimum standards for the protection of regulatory data. Unfortunately, Article 39 is not altogether clear and consistent in its drafting:

1. In the course of ensuring effective protection against unfair competition as provided in Article 10 bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or government agencies in accordance with paragraph 3.

2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information:

(a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally dealt with the kind of information in question;
(b) has commercial value because it is secret; and
(c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

Note: For the purpose of this provision, “a manner contrary to honest commercial practices” shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who know, or were grossly negligent in failing to know, that such practices were involved in the acquisition.

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilise new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

The minimum threshold of protection required by Article 39.3 is not entirely clear:

The data protected is required “as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilise new chemical entities”. This suggests that this does not require data submitted for other purposes to be protected (although of course it does not exclude it either). Moreover, what is meant by “new chemical entity”? Presumably it does not impose a patent standard of “novelty”, and in any event if it were to, would this be absolute (worldwide) or relative (local)? The term is widely used in a regulatory context, where the term “new chemical entity” means an active approved for the first time within the particular regulatory framework under discussion, as the same chemical may have activity with the context of different regulatory frameworks.

The origination of the data protected must “involve a considerable effort”. Presumably this covers matters such as toxicology in the broadest sense, together with clinical trials for pharmaceuticals or field trials for agrochemicals, but what else?

The use must be “unfair commercial use”. Although the expression “a manner contrary to honest commercial practices” in Article 39.2 is the subject of a definition in a note to the provision, the equally important term "unfair commercial use" in Article 39.3 is not defined. Clearly non-commercial use, such as for public health and safety, is excluded. As to commercial use, such as that made when a second applicant, or to be more accurate, the regulatory authority assessing the second applicant’s application, relies on the fact that such data exists (whether or not it is actually referred to), the issue is whether or not such use is “unfair”. It is in this context that matters such as the appropriate term of protection and the issue of whether or not the protection should be by way of a remuneration right or an exclusive right arise.

Current data protection in the CEE candidate countries

Table 2 sets out in summary the current state of protection provided. In most cases, the candidate countries have adopted the European Medicines Evaluation Agency’s Centralised procedure for the approval of drugs produced through biotechnological processes. In these cases, a 10 year period of protection for the data submitted as a condition of such approval is provided. In the case of drugs submitted to a national authority for approval, however, the picture is more mixed.

Table 2

Country Length of protection (years)
Bulgaria Not yet fully adopted but it is stated to be a priority to be introduced before accession
Czech Republic 6 or 10; 6 may persist beyond patent expiry
Estonia 6 or 10; unknown about relation to patent expiry
Hungary None, but upon accession will provide 6 or 10; 6 not beyond patent expiry
Lithuania None
Poland 3
Romania None in force; provision awaiting approval by the Ministry of Health
Slovakia 6, or 10 proposed for Centralised Procedure drugs
Slovenia 6; not beyond patent expiry

Although the absence of protection in some cases and the linking of the term to patent expiry in others is the subject of objections from the research-based pharmaceutical companies, the reality is that the laws on protection of regulatory data are not well harmonised even within the European Union’s existing members, some of which[8] likewise link the term for protection for patent expiry.

Omissions from TRIPs

Various subjects of considerable interest to the pharmaceutical industry are not explicitly addressed by TRIPs at all.

(1) Experimental Use

Probably the most significant is the issue of whether or not “experimental use” excepted from patent infringement. TRIPs did not get down to this level of detail - most probably, because there was no clear consensus as to how such provisions should work. Since then the European Union has challenged Canada at a World Trade Organisation dispute panel over its “Roche-Bolar” and other patent expiry related provisions.

The area is an interesting and difficult one. Most patent laws have a specific provision which provides that so called "experimental use" is not patent infringement. But that does not help much in deciding what is regarded as “experimental use”, and, in a world which requires ever increasing testing for public health and public safety grounds before a marketing authorisation may be granted for a new pharmaceutical rather than conventional efficacy grounds,[9] it is an extremely vexed question as to what extent conventional concepts of “experimental use” apply to such activities. Different countries have taken different approaches. Some have refined, by the case law, what is, and what is not, regarded as experimental use. Such is the case in Europe and Japan. Others, sometimes in the light of the case law, have introduced express statutory provision for certain testing activities directed towards securing marketing authorisations - for example, the USA introduced the so-called “Roche-Bolar” provision immediately after (and to reverse) the decision in the US case of Roche Products, Inc. v. Bolar Pharmaceutical,[10] in 1984, as part of the Waxman - Hatch Act. Canada introduced an equivalent provision and also permitted pre-patent expiry ‘stockpiling’ of patented products in the six months leading up to the expiry of a patent. Upon challenge by the European Union,[11] the “Roche-Bolar” provision was found not to be incompatible with the TRIPs Agreement, but the pre-patent-expiry stockpiling provision was ruled incompatible.

The experimental use exception in Europe

Most[12] - though not quite all - national European patent laws include an express exemption from infringement[13] for

“experimental purposes relating to the subject matter of the invention”[14].

This exemption does not arise from the European Patent Convention but from the draft Community Patent Convention (“CPC”) which, although reflected in the national laws of most Member States, has never formally become European law. The scope of the exemption has been the subject of case law in a variety of contexts in several Member States, but unfortunately has not reached the point of a complete and clear definition of the activities permitted by it.

Preliminary work directed to issues such as whether one can actually perform the patented invention does appear to be excepted under the “experimental use” provision although direct authority on the point is thin. A useful indication is provided by some comments of the English Court of Appeal in Monsanto v Stauffer[15] in which it was observed

“I would regard the sort of experimental activity which was considered by the Supreme Court of Canada in Microchemicals Ltd v Smith Kline and French ..., viz, a limited experiment to establish whether the experimenter could manufacture a quality product commercially in accordance with the specification of a patent, as being covered by the words ‘for experimental purposes relating to the subject matter of the invention’.”

In order to apply the test, then it is necessary to identify what the invention covered by the patent is - i.e. what is the subject matter? If the experiments relate to that, then they will be exempted. Applying this principle to the sort of tests one meets in connection with pharmaceuticals, then if the patent relates to a novel chemical entity, it would seem that for example stability testing, even if for purely internal purposes, would not necessarily be regarded as “experimentation relating to the subject matter of the invention.” But if the patent were to relate say to some novel formulation technique which improves stability, then a reasonable amount of stability testing should be regarded as experimentation falling within the scope of the exemption from infringement and so excluded.

Most litigation on the subject in Europe has instead concerned the scope of the experimental use exception in relation to clinical trials, and the ECJ’s rulings have only concerned the legality of post-patent-expiry injunctions, a remedy applied by several national courts where infringement by such trials has been found, rather than the scope of the exemption.

Poland, Hungary and Slovenia do at present have express ‘Roche-Bolar’ permissions to conduct clinical trials in order to obtain regulatory approval, and it appears that the EU negotiators are attempting to have these revoked as a condition of accession. If this position prevails then the ability of generic companies to set themselves up to launch immediately upon expiry of a patent by conducting the necessary testing in those countries will be hampered, although of course it will remain possible to conduct the tests elsewhere in the world and bring only the test data into the enlarged Union in order to obtain a marketing authorisation. The position seems somewhat contradictory in view of the recommendation of the Commission’s own Pharmaceuticals Committee that some form of ‘Roche-Bolar’ exemption should be introduced in the EU itself, although the proposal is still at a very preliminary stage. The European Generics Association has clearly been lobbying on this issue, and it is being resisted by some at least of the candidate countries, but it is impossible to tell exactly where the dice will eventually fall.

(2) Parallel imports

The other major omission from TRIPs is any substantive addressing of the issue of parallel imports - the import into a second country of patented[16] goods first placed on the market in another country by the patent owner or with his consent. The latter are the subject of Article 6 of TRIPs, which simply states, under the heading “Exhaustion”

“For the purposes of dispute settlement under this Agreement, subject to the provisions of Article 3 and 4, nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.” [17]

Thus Article 6 has generally been taken to be neutral on the question of whether or not to apply “international exhaustion” whereby a local rights owner such as a patent proprietor cannot use his local rights to prevent parallel imports. It is important to recognise that the principle of exhaustion does not apply to goods first placed on the market in another country by an unlicensed third party. It is also important to appreciate that it can be argued that goods first placed on the market in another country by virtue of a compulsory licence in that country, such as that imposed in August 2001 by the Brazilian government in respect of Roche’s AIDS drug nelfinavir (marketed as Viracept®) ought not be treated as having been put on the market with the consent of the patentee - consent cannot be compelled and hence the patentee’s rights are not exhausted.[18]

In these areas, therefore, the candidate countries now awaiting the conclusion of their negotiations with the European Commission in order to join the European Union, have at present no requirement to make provisions which would bring them into line with European standards. And given that pharmaceutical costs represent a high share of gross domestic product and healthcare spend (1.8% and 40% respectively) for the CEE countries compared to the share it takes in the rest of the Union, there is a clear incentive for reimbursement prices to be kept low in those countries, and hence a potentially very significant opportunity for parallel importing once they have joined, unless measures are taken to limit the movement of drugs between the new and old Member States. It appears that the research based pharmaceutical companies have been lobbying for some sort of transitional measures to be applied, on a product-by-product basis. It remains to be seen how many and which products benefit, and for how long.

Patent term extension - Supplementary Protection Certificates

The most significant difference between EU law and the present laws of the candidate countries is that in the former, research-based industry now has the benefit of patent term extension, intended to compensate it for the delays in getting their products to market that are inherent in the regulatory process, in the form of Supplementary Protection Certificates ("SPC") Regulation. In the latter, such extensions are not yet generally available, although the Czech Republic, Poland and Slovenia, are proposing to bring in SPC legislation even before accession. Hungary, on the other hand, is requesting a transitional period before it is required to bring an equivalent provision in even after accession.

The SPC Regulation has applied since the beginning of 1993 throughout all of the European Union and the rest of the European Economic Area. It has broadly the effect of permitting patentees to "extend", insofar as they relate to a medicinal product having a marketing authorisation, certain pharmaceutical patents which would otherwise have expired, for the shorter of

  • a further 5 years beyond their original 20 year term; or
  • 15 years from the grant of the first EEA marketing authorisation for the medicinal product that they protect.

Getting to the present stage of relative uniformity even throughout the existing Member States was not simple. To start with, the application of the SPC regime to Greece, Portugal and Spain was deferred until 1998 but there were no transitional provisions providing for marketing authorisations applying from a certain date. In other countries there were transitional provisions, but the Member States picked a variety of different cut-off dates from which the relevant marketing authorisation had to have been obtained, which meant that in those countries which picked earlier cut-off dates (1982 rather than 1985) more drug patents initially benefitted from SPCs, and in those which picked later ones (1988) fewer did.

Finally, there were the national regimes introduced after the start of 1993, pending the coming into force of the European Economic Area Treaty. This led to certain anomalies in the transitional provisions as to replacing the national provisions most notably in Sweden.

Moreover differing national offices have in the past adopted differing approaches (only one of which can be correct), for example as to what is a first marketing authorisation. Many of the issues which have arisen in relation to SPCs have done so in the context of attempts to establish that the “first authorisation” in the Community was later than one of the cut-off dates, or to ensure that the maximum length of protection is secured. As new countries join, there will be products with existing marketing authorisations in those new Member States which may have been granted other than under the Community’s provisions. To what extent should such authorisations granted be properly regarded as “first marketing authorisations in the Community” for the purposes of the Regulation? The national patent offices seem now to have taken the view, although this has never been contested in a proceeding, that any marketing authorisation within the Community, even if not granted under the provisions of the relevant EU Directive, was sufficient to constitute a first marketing authorisation for the purposes of the SPC Regulation. So the applicant for a marketing authorisation should from now on in take care as to where the first such authorisation will end up being granted, because it could well affect the total length of protection the product gets.

This issue was expressly addressed in the amending legislation providing for the EEA and the accession of Austria, Finland and Sweden to the EU. The first of these stated that:

... an authorisation to place the product on the market granted in accordance with the national legislation of the EFTA State shall be treated as an authorisation granted in accordance with Directive 65/65/EEC ...

It would seem likely therefore that the amending legislation bringing any new members in will address the point as well. Nevertheless, complicating factors can be confidently predicted to reappear once the new members begin attempting to apply the SPC Regulation in their own regimes.

Progress of the accession negotiations

The Copenhagen European Council of June 1993 laid down four basic criteria for accession. The candidate countries need to:

  • have set up stable democratic institutions;
  • have a functioning market economy that is able to withstand competitive market pressures;
  • adopt the entire body of existing EU law; and
  • last but not least have the administrative capacity to implement this "body of law".

There is no option of not aligning the candidate countries’ laws in any area: if they genuinely want entry to the club, they have to accept all of the rules. And at present, negotiations are in progress on the basis that entry to the club is genuinely what they want - though there have been increasing signs in some, such as Poland and Estonia, of popular uncertainty as to whether the membership is worth the subscription. However, the Commission has acknowledged that, as in earlier enlargements, some technical adjustments and temporary transitional measures, will be necessary although the Commission measures must be limited in time and scope, and will be accompanied by a plan with clearly defined stages. As the negotiations are being conducted at governmental level, there is little information as yet available as to what transitional measures in the field of pharmaceutical patent protection may ultimately be agreed.

The negotiations are taking the form of a series of bilateral intergovernmental conferences between the EU-Member States and each of the candidate countries, the most recent of which was completed in July this year. The actual negotiations are based on detailed evaluations prepared by the Commission on the situation of each country in relation to the accession criteria and their factual legislative and administrative alignment as regards each specific sector of Community law. Table 3 shows where the negotiations are on a country by country basis for five of the CEE countries, with respect to each area currently under discussion - and quite a lot of areas are not shown, being provisionally ‘closed’, meaning that agreement has been reached so the discussions are finished subject to approval by the various national governments. But the rate of progress is different for each candidate country because each one is judged on its merits and a technical evaluation of its individual efforts. This means that each candidate or group of candidates is expected to join the EU when it is able to show that it has met the four criteria for membership, which could be a different date for each one of the 12.

Table 3

Chapter Czech Republic Estonia Hungary Poland Slovenia
Free movement of persons
Free movement of capital
Company law
Justice/ home affairs
Financial control
Financial/ budgetary

Dates for accession have not been fixed yet by the Council of Ministers, but as stated above the earliest date is 2003, which is the date the European Union has set itself for being ready to receive any of the new members.[19] Preparing the Union for enlargement was the objective of the not-wholly successful Nice Intergovernmental Conference on institutional reform in December 2000, and the ratification process of the accession treaties will only start after the results of the necessary institutional reforms of the EU have been carried through.

So there is a real issue as to whether either side will meet this deadline. In reality, 2005 is now seen as the earliest possible date for accession by any of the candidates.

As the table shows, justice and home affairs, which includes the effectiveness of the administration and court systems, remains a live issue for most of them. The bottom line with any agreement is, no matter how closely the terms agreed may fit the EU negotiators’ proposals, the agreement is only as good as the systems for implementing and enforcing it. There are still areas of the current EU where enforcement is something of a hit and miss affair, and the majority of the candidate countries are still in transition from a ‘command and control’ system where the civil administration and the courts were entirely secondary to the dictates of the Party. There is no doubt that the efforts being made to transform their economies to Western-style free markets are sincere. Nevertheless, it will take some time before the benefits of joining and the exposure of the individuals who make up the operational elements of the administration and judicial systems to Western European methods of analysis combine to bring about a grass-roots shift to a more Western way of doing things.

First published in the March 2002 edition of EIPR.

[1] Lithuania, however, joined the WTO only in May 2001
[2] [1995] RPC 568, SRIS C/56/97
[3] SRIS C/62/95, SRIS C/98/97
[4] Bristol Myers Squibb v Baker Norton & Napro - Mr Justice Jacob, July 1998. In May 2000 the Court of Appeal upheld the findings on novelty and obviousness and in addition found the patent invalid as a method of treatment.
[5] Section 6
[6] Blanks in this and subsequent tables indicate only the author’s inability to locate any concrete information on a point.
I am indebted to Trevor Cook’s Special Report, The protection of regulatory data in the pharmaceutical and other secotrs, pub. Sweet & Maxwell, 2000, for the following discussion.
Greece, Portugal and Spain
>[9] In 1965 it took an average of 8.1 years to bring a new pharmaceutical to market; by 1995, the average had reached 14.9 years. Much of this increase is attributable to the additional testing and clinical trials which are now required to ensure adequate safety.
[10] 733 F.2d 858, 221 USPQ 937
[11] Proceedings WT/DS114/R
[12] With the notable exception of Switzerland - which of course is not a member of the European Union
[13] In certain cases another express exception, that for “acts done privately and for non-commercial purposes” has been asserted, although given that the aim will almost always be wholly commercial, this has had little success as a defence.[14] As it is described in section 60(5)(b) of the UK Patents Act, reflecting, as for example German law, the wording of Article 31 of the 1975 text of Community Patent Convention, and Article 27 of the 1989 text.
[15] [1985] RPC 515
[16] Or goods protected by trade mark or other IPRs
[17] Article 3 and 4 deal with National Treatment and Most Favoured Nation Treatment respectively but essentially preclude, with certain exceptions, discriminatory treatment as between different Member States.
[18] First established in European law in the case of Pharmon v Hoechst ([1985] 3 CMLR 775)
[19] The latest proposed accession date is currently 2007, for Lithuania