Brexit Scenarios and Trade in Pharmaceutical Products

 
PIIS086904990013996-7-1
DOI10.31857/S086904990013996-7
Publication type Article
Status Published
Authors
Affiliation: Institute of Europe RAS
Address: Russian Federation, Moscow
Journal nameObshchestvennye nauki i sovremennost
EditionIssue 1
Pages117-131
Abstract

The paper reviews different Brexit scenarios (from membership in the European Economic Area to a no-deal withdrawa)l in the context of trade in the pharmaceutical industry. It examines which consequences a trading relationship based on the WTO rules would have had on the pharmaceutical industry. The article stresses the importance of the mutual recognition principle and demonstrates its implementation in the European Union’s relations with third countries. The author concludes that the EU-UK Trade and Cooperation Agreement addresses the stakeholders’ major concerns. However, its application will require additional guidance from the parties and the element of competition is to strengthen.

KeywordsBrexit, European Union, Single Market, international trade, pharmaceutical market, European Commission, WTO, free trade agreements, tariff and non tariff barriers
Received25.02.2021
Publication date03.03.2021
Number of characters36668
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1 Обеспечение свободы торговли – одновременно и причина, и цель существования Европейского союза. Состояние будущих торговых отношений стало ключевым вопросом и в теме выхода Великобритании из ЕС. Несмотря на политическое значение процесса для европейского проекта, именно торговля находилась в центре переговоров. В декабре 2020 г. сторонам удалось прийти к масштабному торговому соглашению, определившему, как британские фармацевтические компании будут работать с европейскими клиентами и наоборот. Однако до последнего момента существовало несколько альтернативных сценариев. В данной статье предложено рассмотреть каждый из них с точки зрения появления тех или иных торговых ограничений для понимания возможностей и связанных с ними рисков.
2 В первой части исследованы факторы зависимости британской отрасли от единого внутреннего рынка. Большая часть их действует и в противоположном направлении, однако было правильным сосредоточиться именно на эффектах для Великобритании. Будучи инициатором перемен, эта страна и теперь имеет статус третьей по отношению к 27 государствам объединения. Вторая часть статьи посвящена договорным вариантам Брекзита: от маловероятного изначально членства в ЕЭЗ до заключенного в итоге экономического соглашения, выходящего за рамки классической зоны свободной торговли. Наконец, третья часть касается выхода Великобритании из ЕС без соглашения.
3

Значение европейского рынка для британской фармацевтической отрасли

4 В описании значения торговли для обеих сторон первым фактором неизменно остается ее объем. В 2019 г. Великобритания была третьим партнером ЕС-27 по объему экспорта и импорта медицинских и фармацевтических товаров (10% и 12%, соответственно)1. Общий объем европейского2 экспорта в этой категории составил 202,9 млрд евро, из которых в США – 64,8 млрд, в Швейцарию – 22,3 млрд евро, а в Соединенное Королевство – 20 млрд евро. В том же году двадцать семь стран импортировали продукции на 92,7 млрд евро, из них американской – на 29,2 млрд евро, швейцарской – на 29,8 млрд евро и британской – на 10,7 млрд евро [Eurostat 2021]. 1. Статья опирается на Международную стандартную торговую классификацию ООН (англ. SITC), четвертый пересмотренный вариант. Медицинская и фармацевтическая продукция представлена в отделе 54.

2. В исследовании прилагательное «европейский» относится к 27 странам-членам Европейского союза.
5 В финансовом выражении для Великобритании европейский рынок еще более значим [Хесин 2016, с. 16–17; Бажан 2017, с. 26]. В 2019 г. указанные выше цифры товарооборота с ЕС составили 46% экспорта фармацевтических товаров (в первую очередь в Германию, Нидерланды, Ирландию, Францию и Италию) и 76% импорта (главным образом из Нидерландов, Германии, Бельгии, Ирландии и Франции). В списке основных получателей британской продукции за Евросоюзом следуют США (23%), Китай (4%) и Япония (3%). Импортирует же Великобритания, помимо ЕС-27, преимущественно из Швейцарии (13%) и США (9%) [Eurostat 2021].
6 Фармацевтика – одна из главных экспортных отраслей Соединенного Королевства с долей в 6,5% [Barber 2019, p. 13]. Фармацевтические предприятия в Британии входят в списки крупнейших налогоплательщиков и работодателей среди всех отраслей, поэтому любые изменения в их финансовом положении серьезно скажутся на всей экономике. К примеру, с точки зрения рыночной капитализации AstraZeneca и GlaxoSmithKline заняли в 2020 г. второе и четвертое места, соответственно [Killian 2020]. По данным представителей фармацевтической ассоциации, от этой отрасли – по определению нетрудоемкой – сегодня зависит 63 тыс. рабочих мест (0,2% от общего числа занятых). Из них 24 тыс. задействованы в НИОКР [House of Commons 2020a; Office for National Statistics 2020]. В 2018 г. выпуск сектора составил 0,7% ВВП и 7% промышленного производства [Barber 2019, p. 11]. Вместе с тем производительность труда по валовой добавленной стоимости – 330 тыс. фунтов на одного работника [House of Commons 2020a].

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1. Babynina L.O. (2019a) Posledstviya brekzita bez sdelki // Itogi pravleniya Terezy Mehj. Otv. red. E.V. Anan'eva. DIE RAN. № 364. S. 99–105.

2. Babynina L.O. (2019b) Evropejskij soyuz: vyzov brekzita // Evropa mezhdu trekh okeanov. Pod obsch. red. Al. A. Gromyko, V. P. Fyodorova. Moskva, Sankt–Peterburg: Nestor–Istoriya. S. 71–89.

3. Babynina L.O. (2020) Problemy Evropejskogo soyuza v kontekste brekzita // Evropa v poiske novykh reshenij. Otv. red. R.N. Lunkin, P.V. Oskolkov. DIE RAN. № 372. S. 46–52.

4. Bazhan A.I. (2017) Konkurentsiya kak prichina Brekzita // Ehkonomicheskie aspekty Brekzita. Otv. red. A.I. Bazhan. DIE RAN. № 345. S. 26–34.

5. Kondrat'eva N.B., Khromakov D.O. (2020) Farmatsevticheskij rynok ES: problemy konkurentsii. // Mirovaya ehkonomika i mezhdunarodnye otnosheniya. T. 64. № 2. S. 53–62.

6. Pravitel'stvo RF (2020) Postanovlenie «O vvedenii vremennogo zapreta na vyvoz otdel'nykh vidov produktsii iz Rossijskoj Federatsii». 2 marta (http://static.government.ru/media/files/ odPVbEJwgG6QH0ryelXGwq AIBTnzjfMm.pdf).

7. Khesin E.S. (2016) Ehkonomicheskie posledstviya vykhoda Velikobritanii iz ES // Referendum o chlenstve Britanii v Evrsoyuze: khod, itogi i posledstviya. Chast' I. Otv. red. E.V. Anan'eva. DIE RAN. № 330. S. 13–21.

8. Shelyubskaya N.V. (2017) Problemy razvitiya nauki i innovatsij v ES v svete Brekzita // Ehkonomicheskie aspekty Brekzita. Otv. red. A.I. Bazhan. DIE RAN. № 345. S. 79–89.

9. ABPI (2020a) COVID threat must inject urgency into trade talks, say UK & EU pharma bodies (https://www.abpi.org.uk/media-centre/news/2020/ september/ covid-threat-must-inject-urgency-into-trade-talks-say-uk-eu-pharma-bodies/).

10. ABPI (2020b) Joint EU-UK pharmaceutical industry response to Brexit deal. December 24 (https://www.abpi.org.uk/media-centre/news/2020/december/joint-eu-uk-pharmaceutical-industry-response-to-brexit-deal/).

11. Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (2002) Official Journal, L 114, April 30, p. 369–429 (https://eur-lex.europa.eu/legal-content/ EN/TXT/?uri=CELEX%3A22002A0430%2805%29).

12. Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (2020) Official Journal, L 29, p. 7–187 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12020W/TXT#d1e32-102-1).

13. Babynina L.O. (2019a) Posledstviya brekzita bez sdelki [The Implications of No-deal Brexit]. Itogi pravleniya Terezy Mej. E.V. Ananieva (ed.). DIE RAN, no. 364, pp. 99–105.

14. Babynina L.O. (2019b) Evropejskij soyuz: vyzov brekzita [The European Union: the Challenge of Brexit]. Evropa mezhdu trekh okeanov [Europe Between Three Oceans]. Al.A. Gromyko, V.P. Fyodorova (eds.). Moscow, St.-Petersburg: Nestor-Istoriya, pp. 71–89.

15. Babynina L.O. (2020) Problemy Evropejskogo soyuza v kontekste brekzita [The Problems of the European Union in the Context of Brexit]. Evropa v poiske novyh reshenij [in: Europe in Search of New Solutions]. R.N. Lunkin, P.V. Oskolkov (eds.). DIE RAN, no. 372, pp. 46–52.

16. Banik N., Stevens P. (2015) Pharmaceutical tariffs, trade flows and emerging economies (https://geneva-network.com/wp-content/uploads/2015/09/ GN-Tariffs-on-medicines-1.pdf).

17. Barber S. (2019) Brexit and medicines regulation (https://researchbriefings.files.parliament.uk/documents/CBP-8148/CBP-8148.pdf).

18. Barnier M. (2020) Press statement by Michel Barnier following Round 6 of the negotiations for a new partnership between the European Union and the United Kingdom. European Commission. July 23 (https://ec.europa.eu/commission/ presscorner/detail/en/STATEMENT_20_1400).

19. BBC (2018) Brexit: Amber Rudd says Plan B options plausible. December 8 (https://www.bbc.com/news/uk-politics-46490642).

20. Belfast Telegraph (2018) ‘At least 10’ Cabinet ministers back Norway-style Brexit. December 7 (https://www.belfasttelegraph.co.uk/news/northern-ireland/at-least-10-cabinet-ministers-back-norway-style-brexit-37604287.html# An_increasing_trade_surplus).

21. Bazhan A.I. (2017) Konkurenciya kak prichina Brekzita [Competition as the Cause of Brexit]. Ekonomicheskie aspekty Brekzita [The Economic Aspects of Brexit]. A.I. Bazhan (ed.). DIE RAN, no. 345, pp. 26–34.

22. Cabinet Office (2020a) Moving goods into, out of, or through Northern Ireland. GOV.UK (https://www.gov.uk/government/collections/moving-goods-into-out-of-or-through-northern-ireland#history).

23. Cabinet Office (2020b) Press release: Ireland/Northern Ireland Specialised Committee 05 November 2020 GOV.UK (https://www.gov.uk/government/news/ irelandnorthern-ireland-specialised-committee-05-november-2020).

24. Casalicchio E., Pogatchnik S., Isaac A., Gallardo C. (2021) Dublin and London blast Brussels over Brexit deal override in vaccine fight. Politico. January 29 (https://www.politico.eu/article/uk-eu-coronavirus-vaccine-fight-crisis-call/).

25. Commission Implementing Regulation (EU) 2021/111 of 29 January 2021 making the exportation of certain products subject to the production of an export authorisation (2021) Official Journal, L 31I, January 30, pp. 1–8 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R0111).

26. Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part (2017) Official Journal, L 11, January 14, pp. 23–1079 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:22017A0114 (01).

27. Curtis J. (2021) Northern Ireland Protocol: Article 16 and EU vaccine export controls. House of Commons Library. February 2 (https://commonslibrary. parliament.uk/northern-ireland-protocol-article-16-and-eu-vaccine-export-controls/).

28. Decision of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation on the conclusion of seven Agreements with the Swiss Confederation (2002) Official Journal, L 114, April 30, p. 1.

29. Department of Health & Social Care (2018) Batch testing medicines if there’s no Brexit deal: Guidance. GOV.UK (https://www.gov.uk/government/ publications/batch-testing-medicines-if-theres-no-brexit-deal/batch-testing-medicines-if-theres-no-brexit-deal).

30. DIHK (2020) Idea Paper Extension WTO Pharmaceutical Agreement. April 24 (https://www.wto.org/english/tratop_e/covid19_e/dihk_extension_e.pdf).

31. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products Text with EEA relevance. (2011) Official Journal, L 174, pp. 74–87 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32011L0062).

32. EFPIA (2020) Joint Letter on the Need for a Mutual Recognition Agreement between the EU and UK (https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/need-for-a-mutual-recognition-agreement-between-the-eu-and-uk/).

33. European Commission (2015) Administrative Arrangement to exchange non-public information on medicinal products between DG SANTE/EMA and FDHA/Swissmedic. July 9 (https://www.ema.europa.eu/en/documents/other/ administrative-arrangements-exchange-non-public-information-medicinal-products-between-dg-sante_en.pdf).

34. European Commission (2020a) European Union, Trade in goods with Norway (https://webgate.ec.europa.eu/isdb_results/factsheets/country/details_ norway_en.pdf).

35. European Commission (2020b) European Union, Trade in goods with Switzerland (https://webgate.ec.europa.eu/isdb_results/factsheets/country/details_ switzerland_en.pdf).

36. European Commission (2020c) European Union, Trade in goods with Canada (https://webgate.ec.europa.eu/isdb_results/factsheets/country/details_ canada_en.pdf).

37. European Commission (2020d) European Union, Trade in goods with USA (https://webgate.ec.europa.eu/isdb_results/factsheets/country/details_usa_en.pdf).

38. European Commission (2020e) Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions: Pharmaceutical Strategy for Europe. November 25 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761).

39. European Commission (2021a) Union and Common Transit (https://ec.europa.eu/taxation_customs/business/customs-procedures/what-is-customs-transit/common-union-transit_en).

40. European Commission (2021b) CETA explained (https://ec.europa.eu/trade/policy/in-focus/ceta/ceta-explained/).

41. European Commission (2021c) Commission Notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period. Official Journal, C 27/11, January 25 (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021XC0125 (01)&from=EN).

42. European Commission (2021d) Commission puts in place transparency and authorisation mechanism for exports of COVID-19 vaccines. January 29 (https://ec.europa.eu/commission/presscorner/detail/en/IP_21_307).

43. European Medicines Agency (2019) Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 11 July 2019 (https://www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-11-july_en.pdf).

44. European Medicines Agency (2021a) Mutual recognition agreements (https://www.ema.europa.eu/en/human-regulatory/research-development/ compliance/good-manufacturing-practice/mutual-recognition-agreements-mra).

45. European Medicines Agency (2021b) Switzerland (https://www.ema. europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/switzerland).

46. Eurostat (2020) International trade in medicinal and pharmaceutical products (https://ec.europa.eu/eurostat/statistics-explained/index.php?title=International_ trade_in_medicinal_and_pharmaceutical_products&oldid=457953).

47. Eurostat (2021) Comext DS-018995, Division 54 'Medicinal and pharmaceutical products' of the Standard international trade classification revision 4 (SITC Rev. 4) (http://epp.eurostat.ec.europa.eu/newxtweb/).

48. GATT (1994) Trade in Pharmaceutical Products. March 25 (https://www.wto.org/gatt_docs/English/SULPDF/91770009.pdf).

49. Government of Canada (2016) Opportunities and Benefits of CETA for Canada’s Pharmaceutical Exporters (https://www.international.gc.ca/trade-commerce/assets/pdfs/agreements-accords/ceta-pharma-2016-eng.pdf).

50. Herszenhorn D.M, Hanke Vela J. (2021) EU brandishes export ban to claim dibs on vaccines. Politico. January 28 (https://www.politico.eu/article/eu-brandishes-export-ban-to-claim-dibs-on-vaccine-astrazeneca-pfizer/).

51. Hesin E.S. (2016) Ekonomicheskie posledstviya vyhoda Velikobritanii iz ES [The Economic Implications of the UK Withdrawal from the EU]. Referendum o chlenstve Britanii v Evrsoyuze: hod, itogi i posledstviya [in: The UK EU Membership Referendum: It’sCourse, Results and Implications]. Chast' I. E.V. Ananieva (ed.). DIE RAN, no. 330, pp. 13–21.

52. House of Commons (2013) Leaving the EU: Research Paper, vol. 13/42. July 1 (https://researchbriefings.files.parliament.uk/documents/RP13-42/RP13-42.pdf).

53. House of Commons (2018a) The impact of Brexit on the pharmaceutical sector.

54. House of Commons (2018b) EU Exit Analysis Cross Whitehall Briefing. January (https://www.parliament.uk/globalassets/documents/commons-committees/Exiting-the-European-Union/17-19/Cross-Whitehall-briefing/EU-Exit-Analysis-Cross-Whitehall-Briefing.pdf).

55. House of Commons (2020a) Oral evidence: Brexit and the Northern Ireland Protocol, HC 767. November 11 (https://committees.parliament.uk/oralevidence/ 1204/html/).

56. House of Commons (2020b) The UK-EU future relationship: the March 2020 EU draft treaty and negotiations update: Briefing Paper. Number 8923. May 27 (https://researchbriefings.files.parliament.uk/documents/CBP-8923/CBP-8923.pdf).

57. Johnson B. (2020) Statement made on 3 February 2020. UK Parliament. February 3 (https://questions-statements.parliament.uk/written-statements/detail/ 2020-02-03/HCWS86).

58. Jozepa I., Fella S., Browning S., Seely A., Ferguson D., Smith L., Priestley S. (2020) The UK-EU future relationship negotiations: Level playing field: Briefing Paper. Number CBP8852. June 19. (https://researchbriefings.files.parliament.uk/documents/CBP-8852/CBP-8852.pdf).

59. Killian A. (2020) Top 10 largest UK companies by market cap. IG. December 21 (https://www.ig.com/uk/news-and-trade-ideas/top-10-largest-uk-companies-by-market-cap-190715).

60. Knightley P., Evans H. (1979) Suffer The Children: The Story of Thalidomide. New York: The Viking Press.

61. Kondrat’eva N.B., Khromakov D.O. (2020) Farmatsevticheskiy rynok ES: problemy konkurentsii [EU Pharmaceutical Market: Problems of Competition]. Mirovaya ekonomika i mezhdunarodnyye otnosheniya, vol. 64, no. 2, pp. 53–62.

62. Lexchin J., Gagnon M.-A. (2014) CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs. Globalization and Health (https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC4108121/).

63. May T. (2017) Speech Laying Out the U.K's Plan for Brexit. Time. January 17 (https://time.com/4636141/theresa-may-brexit-speech-transcript/).

64. MHRA (2019) Annual Report and Accounts 2018/19 (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/821766/annual_report_2019_for_govuk_new.pdf).

65. MHRA (2020) Guidance on 150-day assessment for national applications for medicines GOV.UK. December 31 (https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines).

66. Neville S. (2019) Will drugs companies follow EU agency from London to Amsterdam? Financial Times. May 16 (https://www.ft.com/content/70897a14-733c-11e9-bf5c-6eeb837566c5).

67. O’Caroll L., Devlin H. (2018) Britain loses medicines contracts as EU body anticipates Brexit. The Guardian. September 2 (https://www.theguardian.com/ business/2018/sep/02/britain-loses-medicines-contracts-as-eu-body-anticipates-brexit).

68. OECD (2020) The Face Mask Global Value Chain in the COVID-19 Outbreak: Evidence and Policy Lessons. May 4 (https://read.oecd-ilibrary.org/view/?ref=132_132616-l4i0j8ci1q&title=The-Face-Mask-Global-Value-Chain-in-the-COVID-19-Outbreak-Evidence-and-Policy-Lessons)

69. Office for National Statistics (2020) Employment in the UK: November 2020 (https://www.ons.gov.uk/employmentandlabourmarket/peopleinwork/ employmentandemployeetypes/bulletins/employmentintheuk/november2020).

70. Political declaration setting out the framework for the future relationship between the European Union and the United Kingdom (2019) Official Journal, C 384I, November 12, pp. 178–193 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12019W%2FDCL%2801%29).

71. Pravitel’stvo RF (2020) Postanovleniye «O vvedenii vremennogo zapreta na vyvoz otdel’nykh vidov produktsii iz Rossiyskoy Federatsii» [Resolution of the Government of the Russian Federation “On the Temporary Ban on Export of Certain Goods from the Russian Federation”]. 2 marta (http://static. government.ru/media/files/odPVbEJwgG6QH0ryelXGwqAIBTnzjfMm.pdf).

72. PwC (2016) Brexit Monitor: The impact on Pharma & Life Sciences (https://www.pwc.nl/en/brexit/documents/pwc-brexit-monitor-pharma-life-sciences.pdf).

73. Shelyubskaya N.V. (2017) Problemy razvitiya nauki i innovacij v ES v svete Brekzita [The Problems of Science and Innovations in the EU in the Light of Brexit]. Ekonomicheskie aspekty Brekzita. [The Economic Aspects of Brexit]. A.I. Bazhan (ed.). DIE RAN, no. 345, pp. 79–89.

74. Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part. (2020) Official Journal, L 444, December 31, pp. 14–1462.

75. Unified Patent Court (2020) UK Withdrawal from the UPCA. July 20 (https://www.unified-patent-court.org/news/uk-withdrawal-upca).

76. WTO (2021) The WTO's Pharma Agreement (https://www.wto.org/english/tratop_e/pharma_ag_e/pharma_agreement_e.htm).

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