June 2011 – One of the main concerns of the current Czech government is the wide-ranging fight against corruption in the public sector and elsewhere … not least the healthcare and pharmaceutical sectors. Now the Ministry of Health (the “Ministry”) has prepared its own measures aimed at cracking down on the apparent corruption surrounding the prescription and sale of pharmaceuticals. According to the Ministry, the measures should more effectively limit the possibility of corruption and unethical behaviour in the marketing of medicinal products.
Present situation
Current Czech law already contains provisions that regulate the advertising of medicinal products. One of the main reasons that they were adopted was the need to limit the opportunities for medical sales representatives to exercise undue influence over persons qualified to prescribe medicinal products. For that reason, current law regulates not only the advertising of medicinal products to the general public, but also the activities of persons who may seek to influence the sale of medicinal products (such as by advertising medicinal products to persons qualified to prescribe or supply them). There are even restrictions on the provision of inducements to prescribe or supply medicinal products and on the sponsorship of professionals attending promotional meetings or scientific congresses (e.g. paying such people’s travel and hotel expenses).
Proposed changes
The proposed new legislation goes even further, imposing restrictions on a fresh group of activities that are deemed to constitute “advertising”. These activities comprise (i) market research and (ii) non-intervention studies. However, studies which do not directly relate to the use of the product in question as a prescription drug but which have wider scientific benefits will be exempt from the proposed changes.
As regards the sponsorship of people attending scientific conferences, the Ministry proposes to broaden the scope of the restriction and apply it in future not only to persons qualified to prescribe or supply medicinal products (mainly physicians and pharmacists), but also to hospitals or employees of health insurance companies. Moreover, the sponsored person will have to provide evidence that he/she has actively participated in the congress (e.g. made a presentation on a specific topic); this should, in the view of the Ministry, further limit the possibility for pharmaceutical companies to influence relevant professionals.
In addition, the proposal calls for a significant increase in the maximum fines for any breach of the rules.
Well-meant, but mistaken
The proposed measures are now being considered within the relevant ministries and other central governmental bodies and are due to be presented to the Government by the end of June 2011. They could enter into force in January 2012. However, it remains to be seen whether and in what form the measures will become law.
The attempts of the Ministry to fight corruption and unethical behaviour in the pharma sector should be welcomed. The current proposal complements earlier measures taken by the Ministry with regard to apparent irregularities within the Ministry itself and in major hospitals established and managed by the state. It is also in line with planned amendments in other fields, such as public procurement.
However, at least some of the measures have been criticised by the affected parties as inappropriate or ineffective. For example, categorising market research and post-registration studies as “advertising” does not seem to be entirely fair. The purpose of market research is completely different from that of advertising; and adjudicating on whether or not certain post-registration studies are of “scientific benefit” (and therefore qualify for exemption from the new regulations) is likely in practice to be an arbitrary and subjective process.
Likewise, the planned increase in the restriction of sponsorship of scientific congresses seems to have been ill-conceived. It appears that the Ministry has confused two separate topics: inducements (such as gifts) and hospitality. In the first place, the provision of inducements is already largely forbidden under current law, so there is no need to forbid it again. And although there is theoretical scope for increased restrictions on the provision of hospitality, they are not particularly practical as the maximum cash value of such hospitality is already very low.
Finally, it is questionable whether the proposed measures are compliant with EU law. The advertising of medicinal products has already been regulated by EU law, in particular by Directive 2001/83. Any additional regulation in this field adopted by the Czech Republic may have a negative impact on the internal market (i.e. pharma companies would face different rules – and so have to adopt different strategies – at home and abroad) and therefore be in breach of EU law.
Conclusion
The proposed amendments by the Ministry of the advertising of pharmaceuticals may have been prompted by the best of motives, but their appropriateness and compliance with EU law are questionable. The Ministry would do better to focus on the effective enforcement of current regulations than create new sets of complicated rules that may scarcely bring about any improvements.
For more information please contact Tomáš Čihula, Counsel, at .