7. Infringing Article 102(a) TFEU? The case of patented pharmaceuticals
7.3 Solutions considered from in-and-outside the realm of competition law
7.3.2 Solutions found within international patent law
leading to diverging conclusions and interpretations, corroding legal certainty for dominant Originators with an EU-wide MA for specific marketed drugs.
Alternatively, it has been suggested to take ex ante probabilities of success and investment of a prospective pharmaceutical product into account in the context of the first of the United Brands-test.232 In principle, there is no concrete objection to this assumption; however, it is submitted that feasibility in practice is doubtful, as confidential economic overhead costs for all projects must be collected by the CA in question. Infringement investigations are time-consuming, and the inclusion of requiring internal documentation would cause further administrative burden on authorities, thereby delaying definitive decision-making even more.
Consequently, the executive capacity of CAs would be more strained, pharmaceutical undertakings would operate under more uncertain market conditions, and the benefits of concluding that prices are too high would only conceptualise long after the damage to the social health system has occurred.
In conclusion, equating high prices of IP protected pharmaceuticals is objectionable, not only on normative and legal, but operational grounds too. It is therefore submitted that competition law intervention on grounds of Article 102(a) TFEU, while certainly possible – and lauded – in cases of off-patent drugs, the framework does not lend itself appropriate for application against IP protected pharmaceuticals. Hence, Member States and EU institutions are advised to look for alternative alleys to keep drugs and treatments affordable without tampering with innovation incentives.
or groundbreaking therapeutic indications for untreated diseases can understandably be defended on grounds of the underlying R&D-investments that enabled the discovery thereof.
This argument is less veritable however when it is invoked for drug repurposing, dosage regimes, drug combinations and known enantiomers of existing compounds. Since prices are not primarily dictated by the term of protection,234 evergreening practices whereby Generic competition is foreclosed, and thus prices are kept high ought to be the real focus of intervention. The EU cannot yet directly tackle this problem independently, given that the ambit of patent law is not within its sphere of competence. Amendment of the EPC – or bringing patent law within its scope through inter alia the establishment of the Unitary Patent Court – would be required to address this, which is a lengthy, political, and diplomatic process. While certainly worthy of consideration, it is unsuitable for attaining a decline in the current price inflations of pharmaceuticals.
Secondly, an extreme approach suggests the abolishment of second medical use patentability altogether and replace it with a stand-alone shorter exclusivity right, thereby following the narrative that justified the exclusion of medical treatment patentability under Article 53(c) EPO.235 Objections thereto generally center around the chilling effects on innovation investments – due to less attractive opportunities of return for research – and price gouging practices during the leftover sole patent period.236 However, the reality is that both of these concerns already take place under the status quo – at least to an appreciable extent.
Investments are already based on projected rates of success and willingness to pay rather than expected added societal benefit. Evergreening practices merely keep this price salvageable for longer than the patent system seemed to have intended.237 Ex ante legal certainty regarding the term of protection would aid both undertakings and national healthcare systems, as negotiations would be more transparent and both parties would have incentives to negotiate a mutually beneficial price.
Finally, a third solution would be the issuance of compulsory licenses ex Article 31 TRIPS. If exorbitant pharmaceutical prices are causing the healthcare systems of Member States to be unable to efficiently guarantee access to affordable medicine, it could be defended that the
234 De Jongh, T. Radauer, A. Bostyn, S. & Poort J. (n48), 157.
235 Bostyn S., ‘Personalised medicine, medical indication patents and patent infringement: emergency treatment required’ 2016 Intellectual Property Quarterly 2, 193-195.
236 Ibid. for a comparable nuance of those fears.
237 Dwivedi G., Hallihosur S. & Rangan L. (n49), 329.
need to create competitive price constraints would create emergencies for patients and society at large, justifying the issuance of compulsory licenses.238 This measure however, is controversial in of itself to say the least, and would lead to staunch opposition from the pharmaceutical sector and drive undertakings away from the supply in the EU, causing bigger problems in facilitating supply. Besides, Article 31(b) TRIPS requires the potential licensee to obtain authorisation of the Originator, and the latter is entitled to adequate remuneration on grounds of Article 31(h) TRIPS, inadvertently opening up debates and litigation akin to what constitutes as a(n) (un)fair price as discussed above.
Article 31(k) TRIPS states that the latter requirement is not applicable in case a judicial or administrative procedure has led to the conclusion that a compulsive license is required to combat an anticompetitive practice concerning a patent. The burden to establish this would therefore again fall on CAs as competent authorities. This would require a similar substantial assessment of competitive criteria as with Article 102(a) TFEU, and thus fail to mitigate administrative objections mentioned under section 7.2.
Thus, although a fair alternative in theory, utilising ‘TRIPS flexibilities’ to combat domestic pharmaceutical prices is not without its own practical complications, and one may justifiably doubt whether these measures will actually achieve their goal without creating substantial inherent problems on their own for the European pharmaceutical market.
238 Kianzad B. (n75), 208-210.
Conclusion & discussion
The premise of this thesis has been providing an answer to the question of whether the legal framework developed in the area of combatting excessive prices ex Article 102(a) TFEU is suitable in situations where the pharmaceutical is protected by virtue of exclusivity rights.
It has been shown that the pharmaceutical market is R&D-intensive, involves large investments in uncertain projects whereof only a handful of projects are responsible of recouping the costs of the remaining unfruitful R&D ventures. Hence, costs are mainly indirectly linked to the final product, and merely looking at production costs would not do justice to the legitimate arguments put forward by pharmaceutical suppliers.
Rigorous regulatory laws enacted to guarantee safety, efficacy and access to medication also inherently constrain the self-correcting factors of markets. Due to market entry being subject to regulatory authorisation, the fragmentation of the demand side of the pharmaceutical market through multiple down-stream responsible agencies with conflicting interests, conventional market forces are unsatisfactory in facilitating competitive Generic entry wherewith prices would be lowered organically.
both IP rights and competition law acknowledge the benefits of innovation and technological progress for society. The ECJ has explicitly confirmed that the enjoyment of IP rights does not in itself amount to either a dominant position or abuse thereof on a market. High prices of IP protected products have to be put in the context of the underlying reasoning of IP law, being that it serves as a trade-off between innovator and society for a limited period of exclusive enjoyment, whereafter the subject becomes public domain.
Article 102(a) TFEU has proven to be an effective tool against excessive prices charged by pharmaceutical companies in cases concerning off-patent products. It is submitted however, that this methodology will translate poorly to situations concerning patented pharmaceuticals.
The benchmarks used either do not exist in cases of patented pharmaceuticals or would lead to the exclusion of costs related to other unsuccessful endeavors required to be offset be the products in question. The latter do not hike up production costs for the product under scrutiny, but nevertheless rightfully are included in pricing considerations for marketed pharmaceuticals to maintain profitably as a business.
Alternative benchmarks have been suggested, such as making QALYs, reflecting the willingness to pay for health services – as formulated in VBP-calculation methods – fungate as maximum prices for patented pharmaceuticals, or by taking ex ante probabilities for rate of success and returns on investments into account. Both of these come with significant drawbacks however, either in the form of strains on CAs’ recourses, being too abstract to objectify or too volatile and dependent on casuistic context in time, subject, and relevant pharmaceutical product. This would risk opening the door to lengthy litigation procedures, concessions or compromising legal certainty as a consequence of a lack of capacity for the EU institutions to set precedents in case law or decisional practice.
All in all, high pharmaceutical prices seem to be a symptom of a larger, fundamental problem with the market structure and forces at play. The costly investments in R&D and infrastructure, legal barriers of entry and the (over-)extension of the patent system through evergreening practices all prevent the emerge of competitive entry, subsequently leading to lower prices. The risks associated with CAs acting as price regulators would furthermore include the chilling effect on certain lifesaving, but costly R&D.
Solutions therefore ought to be found elsewhere, inter alia by tackling secondary patents – or rather the de facto exclusive competence for patent holders to file them – or alternatively, to open up the market through the usage of compulsory licenses as provided for by TRIPS. The answer to the research question thus is that the excessive pricing framework ex Article 102(a) TFEU is not suitable for application in cases of patented pharmaceuticals, and that alternatives are found in amendment of the EPC, or utilisation of TRIPS compulsory licensing framework.
Conclusively, it is submitted that any solution will leave certain stakeholders dissatisfied.
Refusing to act at all will lead to the continuant strain on the limited budget Member States have to finance healthcare and buy pharmaceuticals, while sanctioning on grounds of competition law or otherwise meddling with the principles backing up IP law comes at the risk of subduing vital innovative investments. It is up to national governments, albeit it through collective action through the EU institutions, to ‘pick their poison’ and choose an option that ends up with the least damage to societal welfare.
Bibliography Books:
Cooter R. & Ulen T., Law and Economics (6th edn Berkely Law Books 2016).
Correa C., Trade related aspects of intellectual property rights: a commentary on the TRIPS agreement ( 2nd edn OUP 2020).
Ghidini G., Peritz R. & Ricolfi M. (eds), TRIPS and developing countries: towards a new IP world order? (Edward Elgar Publishing 2014).
Whish R. & Bailey D., Competition Law (9th edn OUP 2018).
Chapters from books:
Bakhoum M., ‘Intellectual Property Rights (IPRs), Competition Law and Excessive Pricing of Medicines’ in: Correa C. & Hilty R (eds.), Access to Medicines and Vaccines:
Implementing Flexibilities Under Intellectual Property Law (Springer 2022), 277-296.
Brennan T., ‘Should Innovation Rationalize Supra-Competitive Prices? A Skeptical Speculation’ in: Konkurrensverket, The Pros and Cons of High Prices (Leananders Grafiska 2007), 88-127.
Cockburn I., ‘Intellectual Property Rights and Pharmaceuticals: Challenges and
Opportunities for Economic Research’ in: WIPO, The Economics of Intellectual Property:
Suggestions for Further Research in Developing Countries and Countries with Economies in Transition 2009, 150-173.
Crampes C., Encauoua D. & Hollander A., ‘Competition and Intellectual Property in the European Union’ in: Clarke R. & Morgan E. (eds.), New developments in UK and EU competition policy (Edward Elgar Publishing 2007), 202-231.
Heinemann A., ‘Abusive filing of IP rights’ in: Mathhews D. & Zech H. (eds.), Research Handbooks in Intellectual Property series (Edgar Elgar Publishing 2017), 468-481.
Hernández F., ‘Article 102 TFEU: Patent Filings as an Abuse of Dominant Position after AstraZeneca: the Patent–Antitrust Interface under a new Perspective’ in: Figueroa P. , Guerrero A. (eds.), EU Law of Competition and Trade in the Pharmaceutical Sector: (Edgar Elgar Publishing 2019), 219-246.
Kianzad B., ‘Excessive Pharmaceutical Prices as an Anticompetitive Practice in TRIPS and European Competition Law’ in: Mathis K. & Tor A. (eds), New Developments in Competition Law and Economics (Springer 2019), 197-220.
Klepper G., ‘Pharmaceuticals’ in: Buigues P. & Jacquemin A., European Policies on Competition, Trade and Industry, (Edgar Elgar Publishing 1995), 329-366.
López A., ‘Innovation and Appropriability, Empirical Evidence and Research Agenda’ in:
WIPO, The Economics of Intellectual Property: Suggestions for Further Research in Developing Countries and Countries with Economies in Transition January (2009 World Intellectual Property Organization), 2-32.
Motta M & de Streel A., ‘Excessive Pricing in Competition Law: Never say Never?’ in:
Konkurrensverket, The Pros and Cons of High Prices (Leananders Grafiska 2007), 14-46.
Odudu O., ‘The Distributional Consequences of Antitrust’ in: Marsden P. (eds.), Handbook of Research in Trans-Atlantic Antitrust (Edward Elgar Publishing, 2007), 605-622.
Ullrich H., ‘Strategic patenting by the pharmaceutical industry: towards a concept of abusive practices of protection’ in: Drexl J. & Nari L. (eds.), Pharmaceutical innovation, competition and patent law (Edgar Elgar Publishing 2013), 241-272.
Journal Articles:
Abbas M., ‘Evergreening of pharmaceutical patents: A blithe disregard for the rationale of the patent system’ 2019 Journal of Generic Medicines 15(2), 53-60.
Akker I. & Sauter W., ‘Excessive pricing of pharmaceuticals in EU law: balancing competition, innovation and regulation’ 2021 SSRN Papers.
Bader M, Gassmann O. & Ziegler N., ‚Getting the most out of your IP –
patent management along its life cycle‘ 2012 Drug Discovery Today 17(7-8), 281-284.
Basarik H., ‘The Role of Article 102 in European Pharmaceutical Sector’ 2015 Global Antitrust Review 8, 27-67.
Bostyn S., ‘Personalised medicine, medical indication patents and patent infringement:
emergency treatment required’ 2016 Intellectual Property Quarterly 2, 151-201.
Bostyn S., ‘Review of the Balance of Competences - Intellectual Property Law’ 2013.
Batchelor B. & Healy M., ‘CJEU AstraZeneca judgment: groping towards a test for patent office dealings’ 2013 European Competition Law Review 34(3), 171-173.
Canoy M. & Tichem J., ‘Lower Drug Prices can Improve Innovation’ 2018 European Competition Journal 14(2-3), 278-302.
Danielli D., ‘Excessive pricing in the pharmaceutical industry: adding another string to the bow of EU competition law’ 2021 Health Economics, Policy and Law 16, 64-75.
Dwivedi G., Hallihosur S. & Rangan L., ‘Evergreening: A deceptive device in patent rights’
2010 Technology in Society 32(4), 324-330.
Evans D. & Padilla A., ‘Excessive Prices: Using Economics to Define Administrable Legal Rules‘ 2005 Journal of Competition Law and Economics 1(1), 97-122.
Fisch A., ‘Compulsory Licensing of Pharmaceutical Patents: an Unreasonable Solution to an Unfortunate Problem’ 1994 Jurimetrics Journal 34(3), 295-315.
Fisher W., ‘Intellectual property and innovation: Theoretical, empirical, and historical perspectives’ 2001 Beleidsstudies Technologie Economie, 1-29.
Flint A. & Payne J., ‘Intellectual property rights and the potential for universal access to treatment: trips, acta and HIV/AIDS medicine’ 2013 Third World Quarter 34(3), 500–515.
Fontijn C., Akker I. & Sauter W., ‘Reconciling competition and IP law: the case of patented pharmaceuticals and dominance abuse’ ACM Working Paper.
Fox E., ‘What Is Harm to Competition? Exclusionary Practices and Anticompetitive Effect’
2002 Antitrust Law Journal 70(2), 371-411.
Garrison L. & Towse A., ‘Value-Based Pricing and Reimbursement in Personalized Healthcare: Introduction to the Basic Health Economics’ 2017 Journal of Personalized Medicine 7(3), 1-10.
Gunther J-P. & Breuvart C., ‘Misuse of patent and drug regulatory approval systems in the pharmaceutical industry: an analysis of US and EU converging approaches’ 2005 European Competition Law Review 26(12), 669-684.
Gurgula O., ‘Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene?’ 2020 IIC - International Review of Intellectual Property and Competition Law 51(9), 1062-1085.
Hovenkamp E. & Lemus J., ‘Delayed entry settlements at the patent office’ 2018 International Review of Law and Economics 54, 30-38.
Hou L., ‘Excessive Prices within EU Competition Law’ 2011 European Competition Journal 7(1), 47-70.
Jommi C. Armeni P., Franscesco C., Bertolani A. & Otto M., ‘Implementation of Value-based Pricing for Medicines’ 2020 Clinical Therapeutics 42(1), 15-24.
Kaplow L., ‘The Patent-Antitrust Intersection: A Reappraisal’ 1984 Harvard Law Review 97(8), 1813-1892.
Kumar A. & Nanda A,, ‘Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU, India and Other Countries‘ 2017 Pharmaceutical Regulatory Affairs 6(1), 1-6.
Lianos I., ‘Competition Law and Intellectual Property Rights: Is the Property Rights’
Approach Right?’ 2006 Cambridge Yearbook of European Legal Studies 8, 153-186.
Lichtenberg F., ‘Pharmaceutical Innovation, Mortality Reduction, and Economic Growth’
1998 NBER Working Papers 6569.
Minn M., ‘Excessive pricing of pharmaceuticals in the Eu: Balancing between Exploitation and Exploitative Abuse’ 2020 TalTech Journal of European Studies 10(3), 92-108.
Pauly M., ‘The Questionable Economic Case for Value-Based Drug Pricing in Market Health Systems’ 2017 Value in Health 20(2), 278-282.
Persson U., Svensson J. & Pettersson B., ‘A New Reimbursement System for Innovative Pharmaceuticals Combining Value-Based and Free Market Pricing’ 2012 Applied Health Economics and Health Policy 10(4), 217-225.
Posner R., ‘Intellectual Property: The Law and Economics Approach’ 2005 Journal of Economic Perspectives 19(2), 57-73.
Posner R., ‘The law & economics of intellectual property’ 2002 Daedalus: Journal of the American Academy of Arts & Sciences 131(2), 5-12.
Pozzo R., ‘Immanuel Kant on Intellectual Property’ [2006] Trans/Form/Ação 29(2).
Radelli M., ‘Patent Evergreening: technological advancement and abusive commercial practices. Availability of essential medicine in the case of access to insulin’ 2021 Queen Mary Law Journal 16(2), 66-95.
Raftery J., ‘Value based pricing: can it work?’ 2013 BMJ 347(7929).
Shadowen S., Leffler K. & Lukens J., ‘Anticompetitive Product Changes in the Pharmaceutical Industry’ 2009 Rutgers Law Journal 41(1), 1-81.
Schmidt H., ‘Competition Law and IP Rights: Not So Complementary: Time for Re-alignment of the Goals?’ 2019 World Competition Law & Economics Review 42(4), 451–474.
Sussex J., Towse A. & Devlin N., ‘Operationalizing Value-Based Pricing of Medicines A Taxonomy of Approaches’ 2013 PharmacoEconomics 31(1), 1-10.
Tuominen N., ‘Patenting Strategies of the EU Pharmaceutical Industry: Regular Business Practice or Abuse of Dominance’ 2012 World Competition 35(1), 27-54.
Vondeling G, Ciao Q., Postma M. & Rozenbaum M., ‘The Impact of Patent Expiry on Drug Prices: A Systematic Literature Review’ 2018 Applied Health Economics and Health Policy 16(5), 653-660.
Policy Documents & reports:
De Jongh, T. Radauer, A. Bostyn, S. & Poort J., ‘Effects of Supplementary Protection Mechanisms for Pharmaceutical Products’ 2018 Technopolis Group Final Report.
Estoppey L., Kurth F. & Romanens M., ‘Toxic Pharma Prices: from Hypothesis to Action?’
2016 Athery’s e-publications.
European Commission, ‘Report from the Commission to the Council and the European Parliament: Competition Enforcement in the Pharmaceutical Sector (2009-2017)’
(Publications Office of the European Union 2019).
European Commission, ‘Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Pharmaceutical Strategy for Europe’ [2020] {SWD(2020) 286 final}.
European Commission notice on the definition of relevant market for the purposes of Community competition law [1997] OJ C 372/5.
European Commission, ‘Pharmaceutical Sector Inquiry Final Report’ [2009].
Executive Summary of the Discussion on Competition and Generic Pharmaceuticals [2015]
DAF/COMP/M(2014)2/ANN6/FINAL.
Guidance on the Commission's enforcement priorities in applying Article 82 of the EC Treaty to abusive exclusionary conduct by dominant undertakings [2009] OJ C 45/7.
Guidelines on the application of Article 101 of the Treaty on the Functioning of the European Union to technology transfer agreements [2014] OJ C 89/3.
Kanavos P. Manning J., Taylor D. Schurer W. & Checchi K., ‘Implementing value-based pricing for pharmaceuticals in the UK’ 2010 2020Health Organisation Final Report.
OECD, ‘Competition and Regulation Issues in the Pharmaceutical Industry’ [2000]
DAFFE/CLP(2000)29.
OECD, ‘Competition Issues in the Distribution of Pharmaceuticals’ 2014 DAF/COMP/GF(2014)3.
OECD, ‘Excessive Prices in Pharmaceutical Markets’ [2018] DAF/COMP(2018)12.
Thomas J., ‘Patent “Evergreening”: Issues in Innovation and Competition’ 2009 CRS Report for Congress.
Websites & Blogs:
Autoriteit Consument & Markt, ‘ACM imposes fine on drug manufacturer Leadiant for CDCA’s excessive price’ (19 July 2021) <https://www.acm.nl/en/publications/acm-imposes-fine-drug-manufacturer-leadiant-cdcas-excessive-price>.
Diederik Schrijvershof, Martijn van der Hel & Jeanne Pletterburg, ‘Pharma and medical devices controversial issues at ACM and NZa in 2019’ (18 February 2019) <
https://www.maverick-law.com/en/blogs/pharma-and-medical-devices-controversial-issues-at-acm-and-nza-in-2019.html>.
European Commission, ‘Antitrust: Commission opens formal investigation into Aspen Pharma's pricing practices for cancer medicines’ (10 February 2021)
<https://ec.europa.eu/commission/presscorner/detail/en/ip_21_524>.
European Commissioner Neelie Kroes, ‘Delivering Better Markets and Better Choices European Consumer and Competition Day London’ (15 September 2005)
<https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_05_512>.
European Commissioner Neelie Kroes, ‘Preliminary Thoughts on Policy Review of Article 82 Speech at the Fordham Corporate Law Institute New York, 23rd September 2005’ (23 September 2005) <https://ec.europa.eu/commission/presscorner/detail/en/speech_05_537>.
Marcel Levi, ‘Dure medicijnen? Het is vette woekerwinst die ten goede komt aan het farmabedrijf’ (9 April 2022) <https://www.parool.nl/columns-opinie/dure-medicijnen-het-is-vette-woekerwinst-die-ten-goede-komt-aan-het-farmabedrijf~bcd99dc3/>.
Margrethe Vestager, ‘Statement by Executive Vice-President Vestager on the Commission decision to accept commitments by Aspen to reduce prices for six off-patent cancer medicines by 73% addressing excessive pricing concerns' (10 February 2021)
<https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_21_526>.
Oxera, ‘Competition law in pharmaceuticals: a moving target?’ (Oxera 15 December 2008)
<https://www.oxera.com/insights/agenda/articles/competition-law-in-pharmaceuticals-a-moving-target/>.
Stichting Farma ter verantwoording, ‘Stichting Farma ter Verantwoording gaat Autoriteit Consument en Markt verzoeken op te treden tegen farmaceutisch bedrijf’ (24 August 2018)
<https://www.farmaterverantwoording.nl/nl/2018/08/24/stichting-farma-ter-verantwoording-gaat-autoriteit-consument-en-markt-verzoeken-op-te-treden-tegen-farmaceutisch-bedrijf/>.
Wilbert Zuil, ‘ACM: Miljoenenboete farmaceut is ook waarschuwing aan andere fabrikanten’
(19 July 2021) <https://www.skipr.nl/nieuws/acm-beboet-leadiant-voor-20-miljoen-na-prijsverhoging-van-50-000-procent/>.
Vinje T., ‘The Intellectual Property and Antitrust Review: European Union’ (The Law Reviews 15 July 2021) <https://thelawreviews.co.uk/title/the-intellectual-property-and-antitrust-review/european-union>.
Competition Authorities’ decisions
European Commission:
Case COMP/A 37.507/F3 – AstraZeneca, Commission Decision of 15 June 2005 relating to a proceeding under Article 82 of the EC Treaty and Article 54 of the EEA Agreement OJ L 332.
Case AT.39985 – Motorola, Commission Decision of 29 April 2014 addressed to Motorola Mobility LLC relating to proceedings under Article 102 of the Treaty on the Functioning of the European Union and Article 54 of the EEA Agreement C(2014) 2892 final
Case AT.39612 – Servier, Commission Decision of 9 July 2014 relating to a proceeding under Article 101 and Article 102 of the Treaty on the Functioning of the European Union C(2014) 4955 final.
Case AT.40394 – Aspen, Commission decision of 10 February 2021 relating to a proceeding under Article 102 TFEU and Article 54 of the EEA Agreement C(2021) 724 final.
Autorita' Garante della Concorrenza e del Mercato:
Case A480 – AGCM decision of 29 September 2016: price increase of Aspen’s drugs.
Case A524 – AGCM decision of 31 May 2022: abuse of dominant position by Leadiant.
Competition and Markets Authority:
Case CE/9742-13 - Decision of the Competition and Markets Authority of 7 December 2016:
Unfair pricing in respect of the supply of phenytoin sodium capsules in the UK.