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Commercial deals to delay introduction of generics: European companies fined

● The company Lundbeck and generic drugmanufacturers have been fined a total of about 146million euros for delaying market entry of generic versions of citalopram in Europe.

resulted in many prescriptions be ing diverted to brands which were not really novel; since the isomers were patented, generic versions could not be marketed (3). Pursuing these anti-generic strat egies (multiplicity of patents, illegal agreements and launch of isomers) is directly detrimental to public health budgets. ©Prescrire References 1- Judgment of the General Court of the European Union “Arrêt dans l’affaire T-472/13 H. Lundbeck A/S and Lundbeck Ltd v European Commission” 8 September 2016: 177 pages. 2- Court of Justice of the European Union “The Court of Justice dismisses the appeals of a number ofmanufacturers ofmedicines involved in an agree ment seeking to delay the marketing of the gener ic antidepressant citalopram” 25 March 2021: 3 pages. 3- IGAS “Évaluation de la politique française des médicaments génériques” Septem ber 2012: 151 pages. ▶ Translated from Rev Prescrire February 2022 Volume 42 N° 460 • Page 147

I n the early 2000s, the company Lundbeck signed agreements with four companies which, as a result, undertook not to market generic drugs based on citalopram in Europe. Lundbeck had previ ously threatened them with legal action for patent infringement. The agreement included large compensatory payments by Lund beck to the generic drug manufac turers (1). After being informed of these agreements by the Danish antitrust authority in 2003, and following inspections, the European Com mission opened an investigation in 2008, concluding in 2013 that there had been anti-competitive practices. Lundbeck’s patents over

manufacturing processes did not justify exclusion of all competition. The Commission imposed a fine of 93.7 million euros on Lundbeck, and a fine of 52.2 million euros on the generic drug manufacturers involved. In its view, the basis for these agreements was “the parties’ common commercial interest not to engage in competition” (1,2). In 2021, the European Court of Justice rejected appeals by the five companies (2). According to the Commission, by delaying market entry of generic versions of citalopram , Lundbeck was facilitating another anti-generic strategy: the launch of an isomer of citalopram , escitalopram (1). Until 2004, the marketing of isomers had

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Prescrire Int • July/August 2022

The evaluation of drugs to treat type 2 diabetes ● Prescrire has responded to a public consultation, organised by the EMA, regarding a reflection paper on the clinical data required for the evaluation of these drugs. N umerous new glucose-­ lowering drugs have been authorised for use in type 2 of diabetes, including long-term complications (2).

as it would be unethical to deny patients an effective treatment when one exists. It is also important for all new drugs to be evaluated in at least two double-blind randomised clin ical trials, in order to limit the impact of any potential biases in an individual trial. ©Prescrire

Prescrire’s view is that any new drug authorised in the European Union, whatever its indication, should have been shown to repre sent a therapeutic advance, in order to offer the patients con cerned better quality care than that already available. In an indication like type 2 dia betes, a new drug can only be shown to represent a therapeutic advance in direct comparison with a standard treatment, using clinical endpoints. Comparison with pla cebo must remain the exception,

diabetes in the European Union. The European Medicines Agency (EMA) organised a public consult ation between May and August 2022, inviting comments on a re flection paper on the data required for the evaluation of drugs used in type 2 diabetes (1). In Prescrire’s response to this consultation, we stressed that the primary aim when treating patients with type 2 diabetes is to prevent or delay the clinical complications

▶ Translated from Rev Prescrire April 2023 Volume 43 N° 474 • Page 305

References  1- EMA “Reflection paper on data required in confirmatory studies of medicinal prod ucts for the treatment of type 2 diabetes” 10 May 2022: 7 pages. 2- Prescrire Editorial Staff “Submis sion of comments on ’Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes’ (EMA/240473/2022)” 30 August 2022: 10 pages.

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