Consumers could shortly be provided with more information about prescription medicines than they currently have access to. The European Commission seems to have deemed that it is now high time to somewhat relax the current stringent ban on direct-to-consumer advertising for prescription medicines which is prevalent across Europe.
To date, EU law permits the advertising of non-prescription medicines but strictly prohibits the direct-to-consumer advertising of prescription medicines.
Neither does the current law make any detailed provision for the type or amount of information on prescription medicines that consumers are entitled to.
The proposed law will maintain the general ban on direct advertising for prescription drugs but will allow industry to utilise the various media in order to provide additional information to the public. The objective behind these new rules is to ensure that EU citizens are provided with understandable, good-quality, objective, reliable and non-promotional information about the benefits and the risks of medicines and treatments.
This new law forms part of a wider package being proposed by the Commission targeting defaults in the regulation of the pharmaceutical sector.
Other measures forming part of this package aim to modernise the rules on pharmađcovigilance in order to ensure that legitimate drugs are marketed safely. The Commission is also proposing a new law in order to protect EU citizens against the risk of counterfeit drugs.
This proposed package has been met by mixed reactions. The medical profession has been greatly sceptical of the benefit to be garnered by consumers from the envisaged relaxation of advertising rules. It is insisting that the provision of information on prescription medicines ought to remain within the sole remit of the prescribing doctor rather than within that of the manufacturer. The profession is insisting that if industry were to be allowed to inform the public directly, a system should at least be put in place to oblige manufacturers to validate the information given according to certain quality criteria.
Allowing industry to "push" information to patients could also lead to increased or inappropriate consumption of medicines, professional doctors' associations and health organisations maintain. Patients would increasingly ask their doctors for prescriptions based on the advertisement and not according to their actual needs, the medical profession has warned.
On the other hand, the pharmaceutical industry which has been consistently lobbying for a change to the EU law on direct advertising of prescription medicines to consumers, has applauded the Commission's effort to somewhat relax the current rules.
Industry is of the opinion that it has had to date too little freedom to inform patients on the products it is legally liable for. It is only right that consumers are able to obtain more information on a prescribed medicine than they are currently entitled to, industry has asserted.
Dr Vella Cardona is a freelance consultant in EU, intellectual property and competition law. She is also a visiting lecturer at the University of Malta.
mariosa@vellacardona.com
To date, EU law permits the advertising of non-prescription medicines but strictly prohibits the direct-to-consumer advertising of prescription medicines.
Neither does the current law make any detailed provision for the type or amount of information on prescription medicines that consumers are entitled to.
The proposed law will maintain the general ban on direct advertising for prescription drugs but will allow industry to utilise the various media in order to provide additional information to the public. The objective behind these new rules is to ensure that EU citizens are provided with understandable, good-quality, objective, reliable and non-promotional information about the benefits and the risks of medicines and treatments.
This new law forms part of a wider package being proposed by the Commission targeting defaults in the regulation of the pharmaceutical sector.
Other measures forming part of this package aim to modernise the rules on pharmađcovigilance in order to ensure that legitimate drugs are marketed safely. The Commission is also proposing a new law in order to protect EU citizens against the risk of counterfeit drugs.
This proposed package has been met by mixed reactions. The medical profession has been greatly sceptical of the benefit to be garnered by consumers from the envisaged relaxation of advertising rules. It is insisting that the provision of information on prescription medicines ought to remain within the sole remit of the prescribing doctor rather than within that of the manufacturer. The profession is insisting that if industry were to be allowed to inform the public directly, a system should at least be put in place to oblige manufacturers to validate the information given according to certain quality criteria.
Allowing industry to "push" information to patients could also lead to increased or inappropriate consumption of medicines, professional doctors' associations and health organisations maintain. Patients would increasingly ask their doctors for prescriptions based on the advertisement and not according to their actual needs, the medical profession has warned.
On the other hand, the pharmaceutical industry which has been consistently lobbying for a change to the EU law on direct advertising of prescription medicines to consumers, has applauded the Commission's effort to somewhat relax the current rules.
Industry is of the opinion that it has had to date too little freedom to inform patients on the products it is legally liable for. It is only right that consumers are able to obtain more information on a prescribed medicine than they are currently entitled to, industry has asserted.
Dr Vella Cardona is a freelance consultant in EU, intellectual property and competition law. She is also a visiting lecturer at the University of Malta.
mariosa@vellacardona.com