Hostname: page-component-cd9895bd7-hc48f Total loading time: 0 Render date: 2024-12-27T05:09:55.542Z Has data issue: false hasContentIssue false
  • English
  • Français

Challenges to sovereign ambitions: forces of convergence and divergence within the global pharmaceutical sector and the UK's withdrawal from the European Union

Published online by Cambridge University Press:  25 June 2020

John S. F. Wright Open the ORCID record for John S. F. Wright [Opens in a new window]  and
Dimitrios Doukas
John S. F. Wright*
Affiliation:
Public Policy, Regulation and Governance, Institute for Public Policy and Governance, University of Technology Sydney, PO Box 123 Broadway, Sydney, NSW2007, Australia
Dimitrios Doukas*
Affiliation:
EU Law, School of Law, The University of Manchester, Oxford Road, ManchesterM13 9PL, UK
*
*Corresponding authors: Email: [email protected]; [email protected]
*Corresponding authors: Email: [email protected]; [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States.

Keywords

Brexitgovernancepharmaceuticalsregulationsovereignty
Type
Article
Information
Health Economics, Policy and Law , Volume 16 , Issue 3 , July 2021 , pp. 256 - 272
Check for updates
Copyright
Copyright © The Author(s), 2020. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

References

Abraham, J (2005) Regulating the drugs industry transparently. BMJ 331, 528–529.CrossRefGoogle ScholarPubMed
Aldonas, GD (2004) ‘International Trade and Pharmaceuticals’, Testimony of Under-Secretary of Commerce for International Trade before a Joint Session of the Senate Finance Committee, Subcommittees on Health and Trade April 27. Available at https://www.finance.senate.gov/imo/media/doc/042704gatest.pdf (Accessed January 2020).Google Scholar
Barber, S (2019) ‘Brexit and Medicines Regulation’, Briefing Paper No. 8148, London: House of Commons. Available at https://researchbriefings.parliament.uk/ResearchBriefing/Summary/CBP-8148 (Accessed July 2019).Google Scholar
Bauschke, R (2010) The Effectiveness of European Regulatory Governance: The Case of Pharmaceutical Regulation. Heidelberg: Ruprecht-Karls-Universität, Available at http://archiv.ub.uni-heidelberg.de/volltextserver/12639/1/Bauschke_Heidok_Dissertation.pdf (Accessed July 2019).Google Scholar
Busfield, J (2003) Globalisation and the pharmaceutical industry revisited. International Journal of Health Services 33, 581–605.CrossRefGoogle Scholar
Busfield, J (2010) ‘A pill for every ill’: explaining the expansion in medicine use. Social Science & Medicine 70, 934–941.CrossRefGoogle Scholar
Cohen, JL (2012) Globalization and Sovereignty: Rethinking Legality, Legitimacy and Constitutionalism. Cambridge: Cambridge University Press.CrossRefGoogle Scholar
DHSC Department of Health and Social Care (2018) Contingency Legislation to Establish MHRA as a Standalone Medicines and Medical Devices Regulator in a Result of No-deal on EU Exit, IA No: DHSC IA 4074, 21 September 2018. Available at https://consultations.dh.gov.uk/mhra/mhra-no-deal-contingency-legislation-for-the-regul/user_uploads/consultation-ia-mhra-dhsc-2.pdf (Accessed July 2019).Google Scholar
DHSC (2019) Explanatory Memorandum to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. Available at http://www.legislation.gov.uk/uksi/2019/775/memorandum/contents (Accessed July 2019).Google Scholar
Dworschak, S (2016) Frühe Marktzutritte im Arzneimittelsektor – Anreize, Ausgestaltung und kartellrechtliche Bewertung. Berlin: Duncker & Humblot.CrossRefGoogle Scholar
EUOECD (2018) Excessive Pricing in Pharmaceutical Markets – Note by the EU to the OECD, 28 November 2018, DAF/COMP/WD(2018)112.Google Scholar
European Convention (2003) Presidium, Draft Constitution, Explanatory Notes, CONV 724/03, 26 May 2003. Available at http://european-convention.europa.eu/pdf/reg/en/03/cv00/cv00724.en03.pdf (Accessed July 2019).Google Scholar
Faunce, T (2015) How the Australia-US free trade agreement compromised the pharmaceutical benefits scheme. Australian Journal of International Affairs 69, 473–478.CrossRefGoogle Scholar
Faunce, T and Lexchin, J (2007) ‘Linkage’ pharmaceutical evergreening in Canada and Australia. Australia and New Zealand Health Policy 4, 1–13.CrossRefGoogle ScholarPubMed
Faunce, T, Bai, J and Nguyen, D (2010) Impact of the Australia–US Free Trade Agreement on Australian medicines regulation and prices. Journal of Generic Medicines 7, 18–29.CrossRefGoogle Scholar
Gehring, T and Krapohl, S (2007) Supranational regulatory agencies between independence and control: the EMEA and the authorization of pharmaceuticals in the European Single Market. Journal of European Public Policy 14, 208–226.CrossRefGoogle Scholar
Gleeson, D, Lexchin, J, Labonté, R, Townsend, B, Gagnon, M-A, Kohler, J, Forman, L and Shadlen, KC (2019) Analyzing the impact of trade and investment agreements on pharmaceutical policy: provisions, pathways and potential impacts. Globalization and Health 15(Suppl 1), 78.CrossRefGoogle ScholarPubMed
Grigoriadis, L (2014) The application of EU Competition Law in the pharmaceutical sector: the case of parallel trade. European Business Law Review 25, 141–201.Google Scholar
Halberstam, D (2012) Local, global and plural constitutionalism: Europe meets the world. In De Búrca, G and Weiler, JHH (eds), The Worlds of European Constitutionalism. Cambridge: Cambridge University Press, pp. 150–202.Google Scholar
Hancock, M (2018) EU Exit – Human Medicines Supply in a March 2019 ‘No Deal’ Scenario. London: DHSC. Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/735745/brexit-medicines-letter.pdf (Accessed July 2019).Google Scholar
HC House of Commons (2018) The impact of Brexit on the pharmaceutical sector, 9th Report of Session 2017–19, London: HC. Available at https://publications.parliament.uk/pa/cm201719/cmselect/cmbeis/382/382.pdf (Accessed July 2019).Google Scholar
HMG Her Majesty's Government (2017) Life Sciences Industrial Strategy. Available at https://www.gov.uk/government/publications/life-sciences-industrial-strategy (Accessed July 2019).Google Scholar
HMG (2018) The Future Relationship between the UK and the EU. Available at https://www.gov.uk/government/publications/the-future-relationship-between-the-united-kingdom-and-the-european-union (Accessed July 2019).Google Scholar
Juillet, Y (2007) Internationalisation of regulatory requirements. Pharmaceuticals Policy & Law 9, 369–382.Google Scholar
Lexchin, J (2011) Canada's patented medicine notice of compliance regulations: balancing the scales or tipping them? BMC Health Services Research 11, 64.CrossRefGoogle ScholarPubMed
Lexchin, J and Gleeson, D (2016) The trans-pacific partnership agreement and pharmaceutical regulation in Canada and Australia. International Journal of Health Services 46, 597–613.CrossRefGoogle ScholarPubMed
Lopert, R and Gleeson, D (2013) The high price of ‘free’ trade: U.S. trade agreements and access to medicines. Global Health and the Law 41, 199–223.Google Scholar
Marsh, D and McConnell, A (2010) Towards a framework for establishing policy success. Public Administration 88, 564–583.CrossRefGoogle Scholar
MHRA (2014) Notes for Applicants and Holders of a Manufacturer's Licence – Guidance Note 5 (2014). Available at https://www.gov.uk/government/publications/medicines-notes-for-applicants-and-holders-of-a-manufacturer-licence (Accessed July 2019).Google Scholar
MHRA (2019) Comparator Products in Bioequivalence/Therapeutic Equivalence Studies after Brexit (2019). Available at https://www.gov.uk/guidance/comparator-products-in-bioequivalencetherapeutic-equivalence-studies-after-brexit (Accessed January 2020).Google Scholar
Miller, V (2017) ‘EU Agencies and post-Brexit Options’, Briefing Paper No. 7957, London: HC. Available at https://researchbriefings.parliament.uk/ResearchBriefing/Summary/CBP-7957#fullreport (Accessed: July 2019).Google Scholar
Paris, F and Ghei, N (2003) The role of reciprocity in international law. Cornell International Law Journal 36, 93–123.Google Scholar
Permanand, G (2006) EU pharmaceutical Regulation: The Politics of Policy-Making. Manchester: Manchester University Press.Google Scholar
Roth, W-H (2007) Möglichkeiten und Grenzen eines einheitlichen Binnenmarktes für Arzneimittel. Europarecht 42, 10–49.Google Scholar
Scholtz, N (2015) Medicinal products in the European Union: the legal framework for medicines for human use. European Parliamentary Research Service. PE 554.174. pp. 1–28. Available at http://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_IDA%282015%29554174 (Accessed January 2020).Google Scholar
Schwarze, J (1998) Die Bedeutung des Territorialitätsprinzips bei mitgliedstaatlichen Preiskontrollen auf dem europäischen Arzneimittelmarkt, In Schwarze, J (ed.), Unverfälschter Wettbewerb für Arzneimittel im europäischen Binnenmarkt: pharmazeutische Produkte im Widerstreit von freiem Warenverkehr und nationalen Preiskontrollen. Baden-Baden: Nomos, pp. 59–74Google Scholar
Schweitzer, SO (2007) Pharmaceutical Economics and Policy, 2nd Edn., Oxford: Oxford University Press.Google Scholar
Smith, C (2019) ‘Safety of Medicines and Medical Devices’, Briefing Report, London: House of Lords. Available at https://researchbriefings.parliament.uk/ResearchBriefing/Summary/LLN-2019-0024 (Accessed July 2019).Google Scholar
Son, K-B, Lopert, R, Gleeson, D and Lee, T-J (2018) Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States. Globalization and Health 14, 101.CrossRefGoogle ScholarPubMed
Walls, H, Smith, RD and Drahos, P (2015) Improving regulatory capacity to manage risks associated with trade agreements. Globalization and Health 11, 14.CrossRefGoogle ScholarPubMed
Wright, JSF, Barron, AJG, Shah, SMB and Klingler, C (2017) Convergence, divergence and hybridity: a regulatory governance perspective on health technology assessment in England and Germany. Global Policy 8, 69–75.CrossRefGoogle Scholar
Agreement on the Withdrawal of the UK from the EU and EAEC (2020) OJ L 29/7Google Scholar
AstraZeneca (2012), Case C-457/10P, EU:C:2012:770CrossRefGoogle Scholar
AKKA (2017), Case C-177/16, EU:C:2017:689Google Scholar
BAA (1999), Case C-100/96, EU:C:1999:129Google Scholar
Boehringer (2007), Case C-348/04, EU:C:2007:249CrossRefGoogle Scholar
Bristol-Myers (1996), Joined Cases C-427/93, C-429/93 and C-436/93, EU:C:1996:282Google Scholar
Centrafarm (1974), Case 16/74, EU:C:1974:115CrossRefGoogle Scholar
[CMA] Competition and Markets Authority, Paroxetine (2016), Case CE/9531/11, Available at: https://assets.publishing.service.gov.uk/media/57aaf65be5274a0f6c000054/ce9531-11-paroxetine-decision.pdf (Accessed July 2019)Google Scholar
CMA, Pfizer (2016), Case CE/9742/13. Available at: https://assets.publishing.service.gov.uk/media/594240cfe5274a5e4e00024e/phenytoin-full-non-confidential-decision.pdf (Accessed July 2019)Google Scholar
De Peijper (1976), Case 104/75, EU:C:1976:67CrossRefGoogle Scholar
Decision 1/2017 of the Committee established under the EU-Switzerland MRA on the Amendment of Chs. 4, 6, 7, 8, 9, 11, 15, 17 and 20 (2017) OJ L323/51Google Scholar
Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (2001) OJ L311/67, as amended (consolidated version) (2019) OJ L12/1Google Scholar
Directive (EU) 2015/2436 of the European Parliament and of the Council to approximate the laws of the Member States relating to trade marks (2015) OJ L336/1Google Scholar
DocMorris (2003), Case C-322/01, EU:C:2003:664Google Scholar
Drug Price Competition and Patent Term Restoration Act (‘Hatch-Waxman Act’), 24 September 1984, Public Law 98-417, 98 Stat. 1585Google Scholar
Duphar (1984), Case 238/82, EU:C:1984:45CrossRefGoogle Scholar
EAEPC (2018), Case T-574/14, EU:T:2018:605CrossRefGoogle Scholar
EU (Withdrawal) Act 2018, c.16. Available at: http://www.legislation.gov.uk/ukpga/2018/16/contents (Accessed: July 2019)Google Scholar
EU (Withdrawal Agreement) Act 2020, c.1. Available at: http://www.legislation.gov.uk/ukpga/2020/1/contents (Accessed: January 2020)Google Scholar
EU-Australia Mutual Recognition Agreement – Sectoral Annex on Medicinal Products GMP Inspection and Batch Certification (2012) OJ L359/2Google Scholar
EU-Canada Comprehensive Economic and Trade Agreement (CETA) (2017) OJ L11/23Google Scholar
EU-Canada Mutual Recognition Agreement – Sectoral Annex on Good Manufacturing Practices (1998). Available at: https://ec.europa.eu/health/sites/health/files/files/international/doc/mraeccan_en.pdf (Accessed July 2019)Google Scholar
EU-Japan Mutual Recognition Agreement (2001) OJ L284/3Google Scholar
EU-New Zealand Mutual Recognition Agreement in Relation to Conformity Assessment (1998) OJ L229/62Google Scholar
EU-Switzerland Mutual Recognition Agreement in Relation to Conformity Assessment (2002) OJ L114/369Google Scholar
EU-US Mutual Recognition Agreement – Amended Sectoral Annex for GMPs (2017) OJ L58/36Google Scholar
Generics (1997), Case C-316/95, EU:C:1997:347CrossRefGoogle Scholar
Generics (UK) (1998), Case C-368/96, EU:C:1998:583Google Scholar
GlaxoSmithKline (2006), Case T-168/01, EU:T:2006:265CrossRefGoogle Scholar
GlaxoSmithKline (2009), Joined Cases C-501/06P, C-513/06P, C-515/06P and C-519/06 P, EU:C:2009:610Google Scholar
Grund (2012), Case E-7/11. Available at: https://eftacourt.int/download/7-11-judgment/?wpdmdl=1720 (Accessed July 2019)Google Scholar
Human Medicines Regulations 2012, S.I. 2012/1916. Available at: http://www.legislation.gov.uk/uksi/2012/1916/contents (Accessed July 2019)Google Scholar
IHT (1994), Case C-9/93, EU:C:1994:261Google Scholar
Ker-Optika (2010), Case C-108/09, EU:C:2010:725Google Scholar
Kohlpharma (2004), Case C-112/02, EU:C:2004:208Google Scholar
Lélos (2008), Joined Cases C-468/06 to C-478/06, EU:C:2008:504Google Scholar
Lundbeck (2016), Case T-472/13, EU:T:2016:449CrossRefGoogle Scholar
Napp (2016) EWHC 1982 (Admin)Google Scholar
Novartis (2004), Case C-106/01, EU:C:2004:245Google Scholar
Novartis (2005), Joined Cases C-207/03 and C-252/03, EU:C:2005:245Google Scholar
Novartis (2017), Joined Cases C-629/15P and C-630/15P, EU:C:2017:498Google Scholar
[OFT] Office of Fair Trading (2011), Reckitt, Case CE/8931/08. Available at: https://assets.publishing.service.gov.uk/media/555de4bbe5274a7084000156/rb-decision.pdf (Accessed July 2019).Google Scholar
Political Declaration Setting Out the Framework for the Future Relationship between the EU and the UK (2019). Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840656/Political_Declaration_setting_out_the_framework_for_the_future_relationship_between_the_European_Union_and_the_United_Kingdom.pdf (Accessed January 2020)Google Scholar
Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (2004) OJ L136/1Google Scholar
Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products (2009) OJ L152/1Google Scholar
Rhône-Poulenc (1999), Case C-94/98, EU:C:1999:614Google Scholar
Roussel (1983), Case 181/82, EU:C:1983:352Google Scholar
Servier (2015), Case C-691/13, EU:C:2015:121Google Scholar
Smith (1996), Case C-201/94, EU:C:1996:432CrossRefGoogle Scholar
Syfait (2004), Case C-53/03, Opinion of AG Jacobs, EU:C:2004:673Google Scholar
Synthon (2008), Case C-452/06, EU:C:2008:565Google Scholar
United Brands (1978), Case 27/76, EU:C:1978:22CrossRefGoogle Scholar
UK-US Mutual Recognition Agreement (2019), 14 February 2019. Available at: https://www.gov.uk/government/collections/uk-us-mutual-recognition-agreement (Accessed July 2019)Google Scholar
Agreement on the Withdrawal of the UK from the EU and EAEC (2020) OJ L 29/7Google Scholar
AstraZeneca (2012), Case C-457/10P, EU:C:2012:770CrossRefGoogle Scholar
AKKA (2017), Case C-177/16, EU:C:2017:689Google Scholar
BAA (1999), Case C-100/96, EU:C:1999:129Google Scholar
Boehringer (2007), Case C-348/04, EU:C:2007:249CrossRefGoogle Scholar
Bristol-Myers (1996), Joined Cases C-427/93, C-429/93 and C-436/93, EU:C:1996:282Google Scholar
Centrafarm (1974), Case 16/74, EU:C:1974:115CrossRefGoogle Scholar
[CMA] Competition and Markets Authority, Paroxetine (2016), Case CE/9531/11, Available at: https://assets.publishing.service.gov.uk/media/57aaf65be5274a0f6c000054/ce9531-11-paroxetine-decision.pdf (Accessed July 2019)Google Scholar
CMA, Pfizer (2016), Case CE/9742/13. Available at: https://assets.publishing.service.gov.uk/media/594240cfe5274a5e4e00024e/phenytoin-full-non-confidential-decision.pdf (Accessed July 2019)Google Scholar
De Peijper (1976), Case 104/75, EU:C:1976:67CrossRefGoogle Scholar
Decision 1/2017 of the Committee established under the EU-Switzerland MRA on the Amendment of Chs. 4, 6, 7, 8, 9, 11, 15, 17 and 20 (2017) OJ L323/51Google Scholar
Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (2001) OJ L311/67, as amended (consolidated version) (2019) OJ L12/1Google Scholar
Directive (EU) 2015/2436 of the European Parliament and of the Council to approximate the laws of the Member States relating to trade marks (2015) OJ L336/1Google Scholar
DocMorris (2003), Case C-322/01, EU:C:2003:664Google Scholar
Drug Price Competition and Patent Term Restoration Act (‘Hatch-Waxman Act’), 24 September 1984, Public Law 98-417, 98 Stat. 1585Google Scholar
Duphar (1984), Case 238/82, EU:C:1984:45CrossRefGoogle Scholar
EAEPC (2018), Case T-574/14, EU:T:2018:605CrossRefGoogle Scholar
EU (Withdrawal) Act 2018, c.16. Available at: http://www.legislation.gov.uk/ukpga/2018/16/contents (Accessed: July 2019)Google Scholar
EU (Withdrawal Agreement) Act 2020, c.1. Available at: http://www.legislation.gov.uk/ukpga/2020/1/contents (Accessed: January 2020)Google Scholar
EU-Australia Mutual Recognition Agreement – Sectoral Annex on Medicinal Products GMP Inspection and Batch Certification (2012) OJ L359/2Google Scholar
EU-Canada Comprehensive Economic and Trade Agreement (CETA) (2017) OJ L11/23Google Scholar
EU-Canada Mutual Recognition Agreement – Sectoral Annex on Good Manufacturing Practices (1998). Available at: https://ec.europa.eu/health/sites/health/files/files/international/doc/mraeccan_en.pdf (Accessed July 2019)Google Scholar
EU-Japan Mutual Recognition Agreement (2001) OJ L284/3Google Scholar
EU-New Zealand Mutual Recognition Agreement in Relation to Conformity Assessment (1998) OJ L229/62Google Scholar
EU-Switzerland Mutual Recognition Agreement in Relation to Conformity Assessment (2002) OJ L114/369Google Scholar
EU-US Mutual Recognition Agreement – Amended Sectoral Annex for GMPs (2017) OJ L58/36Google Scholar
Generics (1997), Case C-316/95, EU:C:1997:347CrossRefGoogle Scholar
Generics (UK) (1998), Case C-368/96, EU:C:1998:583Google Scholar
GlaxoSmithKline (2006), Case T-168/01, EU:T:2006:265CrossRefGoogle Scholar
GlaxoSmithKline (2009), Joined Cases C-501/06P, C-513/06P, C-515/06P and C-519/06 P, EU:C:2009:610Google Scholar
Grund (2012), Case E-7/11. Available at: https://eftacourt.int/download/7-11-judgment/?wpdmdl=1720 (Accessed July 2019)Google Scholar
Human Medicines Regulations 2012, S.I. 2012/1916. Available at: http://www.legislation.gov.uk/uksi/2012/1916/contents (Accessed July 2019)Google Scholar
IHT (1994), Case C-9/93, EU:C:1994:261Google Scholar
Ker-Optika (2010), Case C-108/09, EU:C:2010:725Google Scholar
Kohlpharma (2004), Case C-112/02, EU:C:2004:208Google Scholar
Lélos (2008), Joined Cases C-468/06 to C-478/06, EU:C:2008:504Google Scholar
Lundbeck (2016), Case T-472/13, EU:T:2016:449CrossRefGoogle Scholar
Napp (2016) EWHC 1982 (Admin)Google Scholar
Novartis (2004), Case C-106/01, EU:C:2004:245Google Scholar
Novartis (2005), Joined Cases C-207/03 and C-252/03, EU:C:2005:245Google Scholar
Novartis (2017), Joined Cases C-629/15P and C-630/15P, EU:C:2017:498Google Scholar
[OFT] Office of Fair Trading (2011), Reckitt, Case CE/8931/08. Available at: https://assets.publishing.service.gov.uk/media/555de4bbe5274a7084000156/rb-decision.pdf (Accessed July 2019).Google Scholar
Political Declaration Setting Out the Framework for the Future Relationship between the EU and the UK (2019). Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840656/Political_Declaration_setting_out_the_framework_for_the_future_relationship_between_the_European_Union_and_the_United_Kingdom.pdf (Accessed January 2020)Google Scholar
Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (2004) OJ L136/1Google Scholar
Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products (2009) OJ L152/1Google Scholar
Rhône-Poulenc (1999), Case C-94/98, EU:C:1999:614Google Scholar
Roussel (1983), Case 181/82, EU:C:1983:352Google Scholar
Servier (2015), Case C-691/13, EU:C:2015:121Google Scholar
Smith (1996), Case C-201/94, EU:C:1996:432CrossRefGoogle Scholar
Syfait (2004), Case C-53/03, Opinion of AG Jacobs, EU:C:2004:673Google Scholar
Synthon (2008), Case C-452/06, EU:C:2008:565Google Scholar
United Brands (1978), Case 27/76, EU:C:1978:22CrossRefGoogle Scholar
UK-US Mutual Recognition Agreement (2019), 14 February 2019. Available at: https://www.gov.uk/government/collections/uk-us-mutual-recognition-agreement (Accessed July 2019)Google Scholar