Patients must have Immediate Access to Affordable Generic Medicines at Day One After Patent Expiry: The EGA Response to the Public Consultation ‘DG Competition Pharmaceutical Sector Inquiry: Preliminary Report’

Abstract

In her speech launching DG Competition's preliminary report on the pharmaceutical sector inquiry on 28 November 2008, Commissioner Neelie Kroes clearly identified the Report's unspoken conclusion ‘competition in this industry does not work as well as it should’. Among others, the Report rightly identifies delays to generic entry as an important failure of the competitive process in the pharmaceutical sector. The result is that national health-care systems (and patients) pay unnecessarily high prices for pharmaceuticals and, ultimately, that patients are unable to obtain the medicines they need. The behaviour of originator companies is correctly stated to be a significant factor in delays to the entry of generic medicines. As set out in the Report, originator companies have a ‘tool box’ of strategies that they deploy to frustrate the entry of generic medicines. In the opinion of the European Generic Medicines Association (EGA), a number of strategies is the most significant in creating hurdles to generic competition. In highlighting these strategies, the Report confirms the experiences of generic companies operating in Europe. The EGA's members regularly encounter use of each of these strategies when seeking to launch new generic products in EU markets, and will frequently encounter the use of multiple strategies by an originator company in relation to a single medicine and across a range of Member States.

Keywords

EGA (EUROPEAN GENERIC MEDICINES ASSOCIATION)sector inquiry public consultation strategies recommendations originators

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References

European Commission Competition DG. (2008) available at: ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf.

Neelie

Kroes

(2008) Antitrust: Report of Sector Inquiry into Pharmaceuticals. Brussels, 28 November, Speech 08/659, available at: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/speech_nk_hearing.pdf?reference=SPEECH/08/659&format=HTML&aged=0&language=EN&guiLanguage=en.

Absent an absolute ban, changes should be introduced (i) to prevent third party interventions delaying the activation of marketing authorisations once granted and (ii) to give generic companies access to complete information as to the existence and content of third party interventions.

Article 10(6) of Directive 2001/83/EC (as amended by Directive 2004/27/EC) (‘Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products’).

Council Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (the ‘Transparency Directive’).

Although such information and marketing may be prohibited under national rules on unfair advertising or competition in some Member States, the position varies across the EU and the general prohibitions are insufficiently precise to constitute an effective deterrent to this form of behaviour.