How much and in what form pharma manufacturers are allowed to tell patients about the medicines they are taking varies widely across the EU. Hilary Ayshford attended the TOPRA conference where legislation was outlined that could rationalise the situation
The provision of information on medicinal products to patients has been a contentious issue for years. Gaps in the current legislation have led to divergent practices among the EU member states and information that is freely available in some countries may be banned in others.
Naturally, the pharma manufacturers claim they are best placed to advise patients about the medication they are taking, while healthcare professionals believe that the responsibility falls within the bounds of the doctor patient relationship. On one thing, however, all the stakeholders are in agreement: the current ban on direct-to-patient advertising should be maintained.
As part of its package of proposals published at the end of last year, the Commission has proposed an amendment to Directive 2001/83/EC that will introduce a new title into the Code on information to patients, laying down the general rules that will apply to all medicinal products in the Community.
Addressing the TOPRA conference on Proposals for New Pharmaceutical Legislation, Irene Sacristan Sanchez, of the pharmaceuticals unit of DG Enterprise and Industry of the European Commission, stressed the Commission's conviction that not only is there a need to take action at Community level, in particular to address shortcomings in the existing legislation, but also that there is a role for the industry in the provision of information.
"This is becoming very pressing," she said. "Some countries view everything done by the industry as advertising per se because of where it comes from, while others allow the possibility of non-promotional information. It can lead to the case where we have a legally authorised product with the same product information and marketing authorisation valid throughout the whole community, but the information that a patient can get in two different member states is completely different."
The Commission's proposal aims to achieve a harmonised framework for the provision of information of a non-promotional nature by the Marketing Authorisation Holder (MAH) to the public on prescription products while maintaining the current prohibition on advertising.
But one of the main issues to be resolved is exactly what constitutes "advertising". Rather than try to define the term, Sacristan told the delegates, it is better to draw the line between promotional and non-promotional information on the basis of the quality and the purpose of the information and not necessarily the source. "But this does not mean that we consider that industry should be the sole or even the main provider of information," she stressed.
The proposal contains provisions on the content of information to be disseminated, the channels for dissemination, the quality criteria and conditions to be fulfilled, specific rules on Internet websites, monitoring mechanisms and sanctions in case of non-compliance.
"Through this combination of elements we would identify characteristics that information has to fulfil to be allowed; everything else is not allowed."
The type and content of information that may be disseminated by the MAH falls into four categories:
1. The information that is authorised with the product when the MA is issued - i.e. the SPC and the PIL;
2. Information that does not go beyond the contents of the approved texts but that may be presented in a different way;
3. Factual information not perceived as advertising: e.g. prices, reference material and environmental impact;
4. Other medicinal product-related information concerning non-interventional studies, measures accompanying prevention or treatment of the disease.
Channels were one of the most discussed areas in the run-up to the adoption of the legal proposal, and concern about "push" mechanisms led to the explicit exclusion of TV and radio.
Printed media still has a crucial role to play, however, because not everyone has regular access to electronic forms of communication. Unsolicited printed material and mass media are specifically excluded, but it will be up to member states to identify health-related publications in their territory in accordance with local practices.
To meet the requisite quality criteria the information must:
Be objective, unbiased, complete and state benefits and risks alike
Take into account the general needs and expectations of the patient
Be evidence-based, verifiable, including a statement on the level of evidence
Be up-to-date, including the date of publication or last revision
Be reliable, factually correct and not misleading
Be understandable for the general public
State the source of the information
Not contradict the approved SPC, labelling and package leaflet
A mail or e-mail address must be given, and there must also be no inclusion of comparisons between products.
Specific rules are proposed for the Internet, notably that a website must be registered in a member state and the member state will be responsible for monitoring the content. Links to other sites are prohibited unless they are also registered and web-TV and unsolicited material are prohibited.
"The one area where we felt we needed complete provisions was the Internet because it is cross-border in nature - otherwise we could be in a position where a website is controlled 27 times," Sacristan told the TOPRA delegates.
In cases of non-compliance the proposal says that the level of sanctions is to be decided by the member state.
The doctor's view
For Lisette Tiddens-Engwirda, of CPME (Standing Committee of European Doctors), healthcare professionals should remain the principal source of health information to the patient.
CPME is in favour of a well-informed and empowered patient and wants to support different means that can help to achieve this, but the organisation believes allowing the pharma industry to "inform" patients directly would amount to indirect advertising. It is not opposed to the provision of information on the websites of pharmaceutical companies, but opposes allowing the industry to inform patients on an individual basis.
The pharmaceutical industry has a key role to play in providing information on its medicines to healthcare professionals. It is also important that the industry takes responsibility for ensuring that the information provided on its drugs is accurate and up to date and essential that the EMEA and the national regulatory authorities evaluate the information given.
She was particularly concerned that the Commission's proposals do not clearly define "pull" methods of information provision. CPME is not opposed to the provision of information on the websites of pharmaceutical companies, but does not think it appropriate to allow the industry to inform individual patients directly or by any other means.
"It is very difficult to draw a line between advertising and non-promotional information and, for that matter, information presented in a different way," she told the TOPRA conference.
"Most doctors and pharmacists know that patients can be very persuasive when they want a specific medication that they believe is good for them. It is sometimes difficult for doctors or pharmacists to withstand this pressure. An example is the over-prescription of antibiotics."
The end user's view
According to the European Commission's pharmaceutical sector inquiry in 2008, during the period 2000-2007 originator companies spent on average 17% of their turnover from prescription medicines on r&d worldwide; and 23% of their turnover on marketing and promotional activities.
Ilaria Passarani, health policy officer at BEUC, the European consumers" organisation, expressed concern that allowing pharmaceutical companies to supply information direct to consumers would encourage them to devote an even greater share of turnover to marketing at the expense of r&d.
BEUC and its member organisations strongly support the consumer right to access high quality, unbiased and comparative information about health, medicines and treatments but believe that information on medicines should be framed into a wider,
comprehensive and coherent policy of promoting better health information for all, patients, citizens, users or consumers.
In particular, BEUC would like to see statutory information made equally available and accessible in all member states; improvements to the package information leaflet content and its relevance as information tool; and the EMEA's role as a central and impartial source of information about medicines to be fostered.
The industry's view
Patients have a right to information on their prescribed medicines, and companies want to be recognised as trusted partners in providing that information - not alone but alongside and in co-operation with healthcare professionals, patient groups, government agencies and other providers.
What the pharmaceutical industry wants, as outlined by Paul Woods, global compliance policy director at AstraZeneca and co-chair of EFPIA's information to patients task force, is improved access for all EU citizens to non-promotional health and medicines information in their language when they seek it. What it does not want is a US-style direct-to-consumer advertising model.
An important principle is that the acceptability of Information should be based on its quality rather than its source. "It should not suddenly become unacceptable because it has a company logo on the back page," Woods told the TOPRA conference.
But companies must be clear on what they can and can't provide and industry would support robust and clear guidance on comprehensive quality control mechanisms backed up by monitoring and enforcement measures that ensure that the information is non-promotional and of a good standard but without an unnecessary additional bureaucratic burden.
Woods also warned against the risk of downwards harmonisation rather than implementing current best practice across Europe. "Any new regulation must enhance, not reduce the amount of good quality information. No member state should be in a position where it has to take a backward step from its current position in relation to providing information for patients. There is nothing in this proposal that goes further than what is currently allowed in some member states," he stressed.
The aims and objectives of the proposal are very similar to what industry wants:
Ensure the functioning of the internal market
Better protect the health of EU citizens
Provide a clear legal framework for companies for information provision on prescription-only medicines to the general public
Ensure that direct to consumer advertising remains forbidden
EU-wide standards of high quality
Address different needs and capabilities of patients
Allow companies to provide in an understandable way objective and non-promotional information about benefits and risks of their medicines
To ensure compliance with quality criteria while avoiding unnecessary bureaucracy
The real question, Woods concluded, is whether the Commission proposal will meet the stated objectives. The devil, he said, is in the detail, but the proposal should be welcomed not only by industry but also by all players who are concerned about patient welfare.