The trade in illegal pharmaceuticals is a global problem for public health. The transgressions of the rules that govern the distribution and marketing of medicinal products comes in many different forms, including substandard medicines, falsified drugs, counterfeits, ineffective medicines, falsely-labelled medicines and unregistered medicines. All of which breach different provisions of the pharmaceutical legislation and could be appropriately qualified as illegal.
In order to prevent the presence in the market of illegal products is necessary a global approach to define the scope of the problem and the measures to be put in place. It corresponds to the administrative, civil and criminal law to define the different problems and establish the corresponding penalties. Governments on their part should strengthen their controls to detect illegal medicines.
The protection of intellectual property rights is interlinked with the protection from illegal medicines trade and a fundamental issue for the pharmaceutical sector and the patients. If we want better medicines, the patent system is the way to encourage it. An effective intellectual property system provide fair and efficient incentives for innovation. The challenge for governments is to improve the chain of responsibilities to protect the pharmaceuticals market. The improvement of the enforcement of the administrative, civil and penal regulations is imperative.
Under EU law, falsified medicinal products are defined as any medicinal product with a false representation of: (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used.
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Unregistered medicines are those which have not been granted a marketing authorization in a country. Unregistered drugs may be of good quality although some research indicates they often are not. Unregistered medicines usually circulate outside the controlled distribution chain and entail therefore a level of risk.
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IOM (Institute of Medicine). Countering the problem of falsified and substandard drugs. Washington, DC: The National Academies Press. 2013.
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JohnstonA. and HoltD.W., Substandard drugs: A potential crisis for public health, Br J ClinPharmacol78(2) (2014 Aug), 218-243.
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With regard to substandard medical products, the current WHO definition proposed the following non exhaustive elements of a definition: A falsified medical product gives a false representation of its identity and/or source and/or record keeping for traceability; pretends to have been assessed and approved by the competent regulatory authority, pretending to be a genuine quality product; has an intention to deceive by a fraudulent activity; is falsified for profit motives, disregarding public health and safety; and that disputes concerning patents or trademarks must not be confused with falsification of medical products.
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WHO's International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
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BrantJ. and MalpaniR., Eye on the ball medicine regulation - not IP enforcement - can best deliver quality medicines, Oxford, UK: Oxfam International, 2011.
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Directive 2011/62/EU.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. L 174/74 Official Journal of the European Union 1.7.2011.
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The term “falsified” refers to all forms of falsification, while the term “counterfeit” specifically refers to an infringement to intellectual property rights.
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Commission Delegated Regulation (EU) 2016/161.
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Commission Regulation implementing Regulation (EU) No 699/2014 of 24 June 2014, on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity. 25.6.2014 L 184/5 Official Journal of the European Union EN.
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Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use. 25.11.2014 L 337/1 Official Journal of the European Union.
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Commission Implemented Regulation of 23 January 2013, on the assessment of a third country's regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council. L 21/36 Official Journal of the European Union 24.1.2013 OJ L 311, 28.11.2001, p. 67.
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Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products OJ L 210, 7.8.1985, p. 29.
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CliftC., ‘Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals', in Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices, KrattigerA., MahoneyR.T. and NelsenL., eds., available at http://www.ipHandbook.org,MIHR/PIPRA, Oxford, UK/Davis, US, 2007.
GrabowskiH., ‘Data Exclusivity for New Biological Entities', Working Paper, Duke University of Economics, June 2007.
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CockburnI.M., ‘Global Innovation in Pharmaceuticals', in Globalization of Innovation: US Firms Competing in New World, MoweryD., MacherJ. and MerrillS., eds., National Academies Press, Washington D.C., 2008.
AbdulazizA., ZoeA., SaraE. and FabrizioS., A systematic review of counterfeit and substandard medicines in field quality surveys, Integrated Pharmacy Research and Practice (3) (2014), 71-88. https://dx.doi.org/10.2147/IPRP.S63690.
Article 61: Members shall provide for criminal procedures and penalties to be applied at least in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale. Remedies available shall include imprisonment and/or monetary fines sufficient to provide a deterrent, consistently with the level of penalties applied for crimes of a corresponding gravity. In appropriate cases, remedies available shall also include the seizure, forfeiture, and destruction of the infringing goods and of any materials and implements the predominant use of which has been in the commission of the offence. Members may provide for criminal procedures and penalties to be applied in other cases of infringement of intellectual property rights, in particular where they are committed wilfully and on a commercial scale. Part III: Enforcement of Intellectual Property Rights, Articles 41-61. http://www.wto.int/english/docs_e/legal_e/27-trips.doc.
The Council of Europe is the continent's oldest political organisation. Founded in 1949, it has 47 member states, representing more than 820 million Europeans, and five observer states (Canada, the Holy See, Japan, Mexico and the United States of America).
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Council of Europe. Convention on the counterfeiting of medical products and similar crimes involving threats to public health. Moscow, 28.X.2011. Council of Europe Treaty Series-No. 211. (MEDICRIME Convention, CETS No. 211).
EUROPEAN COMMISSION. Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use. 23.11.2013. Official Journal of the European Union C 343/1.
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Refer to USP 1079 for more information on CRT.
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ICH Guidance for Industry: Q1A (R2) Stability Testing of New Drug Substances and Products. And USP <1079> good storage and shipping practices.
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Commission Delegated Regulation (EU) 2016/161 of 2 October 2015, supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use. 9.2.2016 L 32/1 Official Journal of the European Union.
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The European Directorate for the Quality of Medicines and Healthcare (EDQM) is part of the Council of Europe and responsible for the European Pharmacopoeia.
