A new Bill amending the Act on Advertising (No. 40/1995 Coll.) has been proposed by the Czech Government and is currently being considered by the Parliament. According to the Czech Government, corruption and other unfair business practices are still a pressing issue in the Czech public healthcare sector, particularly with respect to advertising of medicines for human use. The new law should address these issues. It is proposed that the new law will be effective from 1 January 2013 although, realistically, it will be later. Besides, after the first reading in the Parliament it now seems the Bill will be subject to numerous changes.
The new Bill defines more precisely what constitutes “advertising of medicines”. Such advertising shall include all forms of informing, surveying and incentives for the purpose of promoting drug prescription, sale, dispensing or consumption. The definition of the sponsorship of scientific conferences becomes wider and also encompasses other similar professional events. The definition of activities falling within the scope of market surveys is extended so it now comprises non-interventional post authorization studies, but does not cover safety studies that are not intended to promote drug prescription, sale, dispensing and consumption.
Sponsorship by pharmaceutical companies
The Bill introduces a new regulatory framework for healthcare professionals’ meetings organized for the purpose of drug prescription, sale, dispensing and consumption. It also covers meetings at scientific conferences or other similar professional events. Such meetings will comply with law if the sponsor or organizer who received sponsorship only provides participants (restrictively) with transportation or travel expenses, accommodation, food or registration fees that would strictly serve for the purpose of the professional event. The Czech Government asserts that the proposal aims above all at the elimination of the “conference tourism” practices.
Liability extends to natural persons
Individuals can now be liable for offering, stipulating and providing gifts in connection to dispensing prescription drugs to the same extent as legal and self-employed persons. The Bill also prohibits healthcare providers and other natural persons authorized to dispense medicines, to provide, offer or stipulate any financial or other benefit in connection to the dispensing of prescription drugs.
Provision of samples
The Bill sets out a maximum amount of samples that the persons authorized to prescribe drugs can obtain. This maximum amount is restricted to a volume sufficient to treat 5 patients during a calendar year (in case of short-term diseases) or 5 patients during 3 months (in case of long-term use). Samples subsidized by the public healthcare insurance policy must not be provided after two years from market launch.
Contests, lotteries and consumer competitions
The Bill explicitly bans advertising of medicines for human use in the form of a contest, lottery or other similar game based on a number of medicines prescribed, consumed or dispensed.
Limiting promotion by sales representatives
According to the Bill, a pharmaceutical or other sales representative shall not visit a healthcare professional during the consultation hours. The Czech Government believes the visits of sales representatives are excessively burdensome for the day to day operations of healthcare professionals and consume much of their time to the detriment of patients. Much of the discussion, including parliamentary and expert debate on this topic, is still ongoing. As this point is highly controversial, some professionals and politicians are taking a strong position that such regulation is fruitless, does not serve any real purpose and the actual control of such regulation would be minimal.
Last but not least, sanctions for breach of the new obligations under the Bill are envisaged to rise. According to the Czech Government pharmaceutical companies often engage in risk-seeking behavior despite the sanctions. Therefore the Government pushed through stricter financial sanctions for pharmaceutical companies in case of violation of their legal obligations (up to 15 million Czech crowns – approx. EUR 600,000).
Other articles in the Life Sciences newletter for December 2012:
> Pan-European declaration of non-infringement can be brought before the English Courts
> Germany: No imminent threat of patent infringement upon obtaining a marketing authorisation
> Spain: Supreme Court ruling on reference pricing system
> CJEU dismisses appeals by AstraZeneca and upholds General Court Judgement
> Dutch reference to the CJEU: Georgetown University v Dutch Patent Office