The Czech Parliament is currently discussing an amendment to Act No. 40/1995 Coll., on the regulation of advertisements (“Advertising Act”), which targets sponsorship, transparency and other matters relating to the advertising of medical products (“Amendment”). The Amendment was originally intended to become effective as of 1 January 2013, but it is now clear that it will not be adopted before the third quarter of 2013. The crucial changes proposed by the Amendment are as follows:
Definition of Pharmaceutical Advertising
The Amendment will supplement the definition on what constitutes the advertising of medicinal products. Such advertising will now include all forms of providing information, surveys, or incentives intended to endorse the prescribing, sale, dispensing or consumption of medicinal products.
Activities in the area of market research aimed at endorsing prescriptions, the sale, dispensing or consumption of medicinal products, including non-interventional post-registration studies, will now expressly be deemed a form of advertising by the Amendment. Such studies will therefore be subject to the rules governing advertisement of medicinal products.
Post-registration safety studies, not intended to endorse the prescription, sale, dispensing or consumption of medicinal products, will be not considered advertising.
The Amendment will further impose a ban on advertising medicinal products in the form of a contest or lottery based on the number of prescribed, consumed or dispensed medicinal products, and will ban any offering of bonuses on the dispensing of prescription only medicinal products reimbursed by public health insurance.
Pursuant to the Advertising Act, hospitality provided to health case professionals, namely to persons authorised to prescribe, supply or sell medicinal products, (“HCPs”) during promotional meetings and scientific congresses must be reasonable and secondary to the purpose of the meeting. Hospitality must not be provided to persons other than the HCPs themselves, e.g. to any family members. The hospitality offered to HCPs must be offered to them during the course of the event and not before or after such event has taken place.
The Amendment will specify that the above rules also apply to any meetings of HCPs similar to scientific congresses and that the hospitality provided to HCPs may only be in the form of arranging transportation or reimbursing travel costs, accommodation, refreshments or registration fees.
The Amendment will introduce an obligation on sponsors of HCPs’ meetings to notify the State Institute for Drug Control (“SIDC”) of the date, venue, focus, agenda and sponsor of the meeting at least ten working days in advance of the meeting and to notify the SIDC of the nature and amount of sponsorship provided during the meeting at least ten working days after the meeting takes place. Information on sponsored events will be disclosed to the public by the SIDC on its website.
On SIDC’s request HCPs will also be obliged to disclose information on the hospitality and benefits received in relation to the promotion of medicinal products.
Provision of Samples and Visits of HCPs
Pursuant to the Advertising Act samples of medicinal products may only be given to HCPs on receipt of a signed and dated request and can only be provided in a limited quantity in the smallest registered package available on the market.
The Amendment is to specify the ‘limited quantity’ as being a quantity necessary to treat five patients with a short-term illness for a year and five patients with a long term illness for three months in each calendar year.
The Amendment will also prohibit the provision of samples of medicinal products reimbursed by the public health insurance funds two years after their introduction to the market.
The Amendment will further impose a ban on visits made by medical sales representatives to HCPs during their contracted working hours.
The Amendment will increase the penalties that can be imposed for breach of the Advertising Act. The maximum fine that may be imposed for an individual breach will be increased from CZK 5,000,000 (approx. EUR 200,000) to CZK 15,000,000 (approx. EUR 600,000).
Advertising of Medicinal Devices
Currently, the advertising of medical devices is not regulated by the Adverting Act or by the Amendment. The Czech Ministry of Health has however recently drafted new legislation specifically concerning medicinal devices pursuant to which the advertising of medical devices shall be regulated in the same manner as the advertising of medicinal products. The new legislation on medicinal devices is yet to be discussed by the Czech Parliament.