Information exchange or promotion - The commission's proposal on information to patients on prescription-only medicinal products

Ian Dodds-Smith

Silvia Valverde - Arnold & Porter (UK) LLP

Society's interest in health issues has greatly increased in recent years with patients becoming ever more health conscious. Patients want to be informed of both established treatments and treatments under research. Many have access to detailed information from a variety of sources through the internet.

In most sectors, those who manufacture products would expect to be a major source of information for those who consume their products. Provision, however, of information to patients on prescription medicines by the pharmaceutical industry raises various regulatory issues.
This article describes the regulatory framework covering information to patients on prescription-only products, and focuses upon the recent Commission proposal to bring about harmonised changes on this subject. The proposal seemingly seeks to balance two important, but conflicting, principles. On the one hand, there is the need to ensure that patients are not exposed to undue influence, or incorrect or misleading information, and that the importance of their doctors as a source of objective advice is not undermined; on the other, there is the desire to respect patients' rights to receive useful information about treatment options that affect their health, and the recognition that the pharmaceutical industry is not only well placed to provide useful, up-to-date and balanced information on their own products, but also have a legitimate interest in providing it.

LEGAL FRAMEWORK
The advertising and provision of information on medicinal products in the EU is controlled by the provisions of Directive 2001/83/EC (the Directive), although Regulation 726/2004 also contains relevant requirements for publication of authorisation information, including summaries of the assessment conducted on product approvals sought centrally. New provisions added as a result of the review of EU legislation in 2004 promoted better quality information for patients, for example, through requirements to ensure readability of the labelling and the package leaflet, and publication of information on the outcome of the assessment procedures. However, there are no other specific rules on the wider provision of information to patients in the Community legislation and, therefore, this activity has not been harmonised, and different member states have developed different approaches.
The Directive includes a general requirement that advertising should not mislead and should "encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties." Regardless of content, however, member states are required to prohibit the advertising of medicinal products to the general public where those products have been classified as prescription-only. The Directive makes a specific derogation in respect of approved vaccination campaigns. These controls derive originally from Directive 92/28/EEC, which justified restrictions on advertising to the general public by saying that "excessive and ill-considered" promotion could adversely affect public health, whether products were classified as prescription-only or non-prescription. The rationale for the further restriction on advertising of prescription-only products was not specifically discussed. The Commission's explanatory memorandum of 1990 contained no discussion on the issue; it merely noted that all member states forbade such advertising and, in the event, the status quo was not disturbed.
The historical reason for such national control, in fact, lay as much in the desire to protect the interests of the medical profession as the sole source of information and counselling, as in the desire to protect patients from inaccurate or unbalanced information. In member states such as the UK even the introduction of detailed package leaflets in the late 1970s, in response to changes in EU law, was met by concerted objections from those representing doctors on the basis that such information undermined the doctor-patient relationship. No doubt, recognising that information to patients is capable of control in much the same way as any other type of information, more recently the objection to manufacturer involvement in the provision of information has often seemed motivated not so much by a fear of the risk of dissemination of inaccurate information but more by a fear that it will encourage patients to ask their doctors for treatment of relatively self-limiting conditions and as a result would put still greater strain on doctors' time and healthcare budgets.
The definition of advertising in article 86 of the Directive is oddly drafted and difficult to apply:
"[A]ny form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products [...]"(emphasis added)
As such it focuses not on the nature of the information supplied, but on a subjective assessment of the purpose of its dissemination. As if anticipating the difficulty in applying this definition in a way that would promote a harmonised application in member states, the relevant article goes on to describe a series of activities to be treated as meeting this definition. Uncontroversially these include detailing by sales representatives and the provision of gifts and other inducements to prescribe. Less helpfully, they refer to sponsorship of "promotional meetings" attended by persons qualified to prescribe and the "advertising" of medicinal products to the general public. Activities expressly excluded from the definition are the provision of package leaflets and of information of a non-promotional nature in response to specific enquiries, factual and informative announcements and reference material ("provided they include no product claims") and statements relating to human health "provided there is no reference, even indirect, to medicinal products."
This framework leaves open the possibility of supplying some information on prescription medicines (licensed and unlicensed) to patients without it being seen as "promotional", but the dividing line between promotional and non-promotional information is blurred. Unsurprisingly, practices common and accepted in some member states have been viewed as controversial in others. Thus, in the UK the competent authority allows the provision to the general public of non-promotional information through press releases on the launch of prescription medicines or milestones in research of unlicensed medicines, whereas many other member states adopt a more restrictive approach. A permissive approach requires a narrow interpretation of what is a "product claim"; references to research results and positive benefit and risk assessments implicitly involve a form of "claim", even if entirely accurate and balanced.
The Medicines and Healthcare products Regulatory Agency's Blue Guide on Advertising of Medicines in the UK notes that press releases and other information provided to the lay press, television or radio must be "factual and non-promotional, where appropriate putting the treatment in the context of the effects of the disease", and that it "should not encourage the general public to ask their GP to prescribe the product." To this end "the use of brand names should be minimised and the tone and content should be factual and balanced." The reality, however, is that information is often sought by patients concerned about their health. While its supply may not be motivated primarily by a desire to encourage such activity, in practice, members of the public will be likely to consult their doctors about new medicines. Nevertheless, that surely cannot, of itself, be treated as objectionable in terms of promotion of public health, although the Code of Practice of the Association of the British Pharmaceutical Industry prohibits the provision to lay persons of information on a new medicine until reasonable steps have been taken to inform doctors and pharmacists.
The Code also encourages companies to put extensive reference material on their websites, including the summary of product characteristics (SmPC), the package leaflet and the public-assessment report. Details of the registration studies (published or not) and material supplied for health-technology assessments on a product's clinical and cost-effectiveness, medicine guides and information about diseases and specific medicines are all allowed under the code, but they must "represent fairly the current body of evidence relating to a medicine and its benefit/risk profile." Such an interpretation of the Directive is increasingly focusing upon the accuracy and balance of information and a generous interpretation of the intent behind dissemination. Nevertheless, it is entirely consistent, in our view, with the overriding requirements of article 10 of the European Convention of Human Rights (freedom of expression) that the right to impart information and to receive it should not be curtailed unless this is necessary and proportionate to protect other important interests, such as the protection of public health.

CHRONOLOGY OF THE COMMISSION LEGAL PROPOSAL
Setting aside the harmonised rules for the content of patient package leaflets, the lack of a comprehensive Community legal framework for information to patients has become more critical over the years. Patients are increasingly inquisitive and wish to be more involved in processes whereby decisions are made affecting their treatments and health. They increasingly use the internet to seek information about medicines and treatments, and much of this information is not designed for laypersons and is of questionable accuracy. It is now widely accepted that modern health challenges such as an ageing population and an increase in adverse conditions such as obesity can only be confronted satisfactorily through a partnership with informed patients. These trends have motivated the European Commission to try to harmonise and improve the access of patients to information on prescription medicines.
Article 88a of the Directive (introduced by the amending Directive 2004/27/EC) provided the legal basis for the Commission to explore current practices on information to patients, and allowed the Commission to put forward proposals for an information strategy for patients. Accordingly, on 19 April 2007, the Commission issued a public consultation on a draft report on current practice. On 18 December 2007, the Commission published its working document, and finally, on 20 December 2007, it published its official communication on the matter. Both the report and the communication concluded that the rules and practices on information to patients were very varied among member states, resulting in unequal access to information on medicines and very variable quality of information.
Last February, the Commission issued a public consultation on the key ideas for the forthcoming draft legal proposal. On 26 May, the Commission published the outcome of this consultation, including copies of all the responses received and a summary of the outcome. Responses were received from healthcare professionals and organisations, patient organisations, regulators, pharmaceutical companies, research organisations, consumer associations, media and patient information organisations and social insurance companies. On the basis of these responses and the results of the impact assessment of the proposal, the Commission will finalise a draft proposal which will start the co-decision procedure involving the European Parliament and the Council. Although the Commission's intention is to issue its official proposal by the end of 2008, the final text of the amending Directive will not be adopted before the end of 2009.

THE LEGAL PROPOSAL
The proposal distinguishes between general and policy objectives. General objectives are to serve the interests of patients, reducing differences in access to information and ensuring good-quality, objective and reliable information. The policy objectives are establishing a framework that promotes those priorities, maintaining the prohibition on direct-to-consumer advertising of prescription medicines and avoiding unnecessary bureaucracy.

Scope
The text of the proposal recognises that one of the essential elements to be included in the final proposal is a clear distinction between advertising and information on prescription medicines. However, the wording of the proposal is, in this respect, confusing. On one side, it provides that communications not covered by the definition of advertisement should be regarded as information, and on the other, it adds that clear criteria would be needed to distinguish permitted and prohibited information. This seems to contradict the suggestion that the legislation already properly defines the dividing line between promotion and information. No criteria are described. It is not surprising, therefore, that the majority of responses received from interested parties comment on this and stress that a clear definition should be provided in the amending Directive.
In this respect, the Commission has two main options: to establish a working definition that could be readily applied to decide whether a particular activity is advertising or information; and to define categories of information that it would be acceptable for the industry to distribute to the public. Although the proposal does not refer to article 86 of the Directive, which, as has been seen, exempts certain categories of information from the definition of advertising, it would be possible to build on this provision to create a clearer list of information categories that would be considered acceptable for distribution to patients.
Clearly distinguishing between advertising and information would only be the first step in achieving a complete harmonisation among member states on this subject. The second step would be to oblige member states to allow information considered as acceptable and non-promotional to be provided to patients by industry.
The proposal mentions that its objective is to set out rules on the provision of information "by marketing authorisation holders". This could be construed as implying that the proposal does not envisage enabling the provision of information prior to the grant of a marketing authorisation, despite that many patients are interested in accessing information on unlicensed medicines and in participating in clinical trials. This aspect should be clarified as it would be artificial to limit the provision of factual information to marketed products. The Directive's controls apply not only to marketing authorisation holders, but also to applicants and to other situations where there is not a marketing authorisation.

Content
While it is easy to see the need for the information provided to be "compatible" with the approved SmPCs and with the content of patient leaflets (and most responders do so), it is less clear that there is a need (as suggested by the proposal) to prevent information going beyond the key elements specified in the SmPC, provided such information remains consistent with it. On the contrary, it is a reality that patients often need to be provided with information that goes beyond the scope of the SmPC, for example, after prescription information such as scope of the optimum areas and timelines for injection, general information on compliance, emergencies, how to travel with their medicines, how to best use any associated delivery device, how to communicate about their condition or how to identify related problems. Such information may be provided by patient associations, but the proposal needs to take into account that not all patients have the motivation or the means to join or participate in patient associations.
An important issue is that as soon as the information provided goes beyond the elements and terms of the SmPC, it becomes more difficult to guarantee that the information is objective, clear and capable of substantiation. One solution could be in the strict control of the sources of such information, for example using public-private partnerships (PPPs), such as the ones in operation in some member states. These PPPs comprise national competent authorities, health-care professionals and other interested parties, including members of the industry, and they contribute in the preparation of information on medicinal products and treatments that comply with all the desirable objectives. Good examples of this initiative are the "Medicines Guides" prepared by a UK PPP, including UK health authorities (NHS direct) and health-care professionals and patients, supported by pharmaceutical companies. The EU Pharmaceutical Forum created by the Commission in June 2005 has identified similar initiatives in other EU member states.

Types of activities
The proposal distinguishes between two main type of activities used in the provision of information: the "push" type (cases where the patient is passively receiving the information) and the "pull" type (cases where the patient is actively searching for the information). Within the latter category, a distinction is made between "soft" and "active" pull. The proposal considers as "soft pull" those activities where the industry disseminates information on prescription medicines through internet websites that may be searched by the public or through oral general communications; for example, presentations and seminars that patients may attend. The proposal considers "active pull" to include written replies by the industry to enquiries from citizens solicited through post or e-mail.
These two categories are the basis for the operation of the monitoring system proposed. The current text of the proposal differentiates between types of actions, but not between types of information or means that can be used to disseminate information.
In all legal proposals there is always a provision that creates special debate. In this case, section 3.3.1 of the proposal has been the object of great criticism and publicity. In that section, the Commission suggests "it should be possible [under the safeguard that all advertising of prescription medicines to the public is banned] for the pharmaceutical industry to disseminate information on prescription-only medicines through TV and radio programmes, through printed material actively distributed, through information in printed media [...] etc." Some independent organisations refer to this paragraph when accusing the pharmaceutical industry of seeking to promote prescription medicines and the Commission of supporting the industry's aims while ignoring patient interests.
The European Federation of Pharmaceutical Industries Associations, the national industry associations and individual pharmaceutical companies have, however, all highlighted in their responses and in previous related consultations that the European pharmaceutical industry does not believe that US-style direct-to-consumer advertising is an appropriate model for the Community, and also that it does not believe that mass media, such as TV and radio, are appropriate ways for the industry to communicate information on prescription medicines to European citizens. In any event, the wording of the proposal in this section is confusing as it refers only to channels for dissemination of information without explaining what types of communication are envisaged and with what content. The Commission's objectives will only be achieved if there is a clearer definition of when the dissemination of information is to be treated as "advertising".

Quality criteria
The quality criteria provided in section 4 of the proposal are clearly worded and do not raise major problems, except in its last sentence, which prohibits comparisons between medicinal products. On the one hand, it is easy to understand why regulators believe that comparisons between products may, in most cases, not be appropriate, as it would imply an "advertising" activity. However, it is also clear that comparisons would be extremely useful, and in some cases there might be a real and urgent need for patients to have access to objective, detailed and clear comparisons between medicines and treatments. This is another example of an important patient need that might possibly be covered by a PPP-type initiative. This is not contemplated in the proposal, but it could be a solution that balances the conflicting interests raised by this activity.

Monitoring and sanctions system
The proposed monitoring and sanctions system is based on the different classification of the types of activities. In summary, it is proposed that "push" activities would be controlled by a simple notification mechanism ("tell and do"), where information providers inform the national co-regulatory bodies about their activities before action is taken. "Soft pull" activities would be controlled by continuous monitoring of content without validating ex post or ex ante specific actions. "Active pull" activities would be monitored on the basis of complaints.
Again, there are many aspects of the proposed monitoring system that are not clear; for example, the form, scope and extent of the notification mechanism, the role of the national co-regulatory bodies that would be monitoring without validating, and how certain activities not considered in the proposal are to be treated, such as telephone inquiries commonly received by industry from patients.
The proposal also opens an interesting debate between two potential options for monitoring this activity. One option would be control via the national competent authorities; a second would be relying on industry self-regulation.

***
The Commission's proposal has raised numerous questions and also new opportunities to reopen old debates. For example, if information provided by the industry through websites is considered useful to patients and acceptable and will be monitored on a regular basis by the competent authorities, would it not make sense to allow website addresses to be included in package leaflets so that patients become aware of them?
The issue underlying this proposal is whether the pharmaceutical industry is an appropriate source of information on prescription medicines in general. Many stakeholders, mainly health-care professionals and institutions and national regulators, have suggested that there may be a conflict of interest in the involvement of the industry in this activity. A majority of the media and patient information organisations (and the industry itself) believe, however, that pharmaceutical companies would be appropriate information providers, as long as there is a clear distinction between information and advertising. This appears to be the stance currently adopted by the Commission.
This latter approach is far more in line with the fundamental right to freedom of expression and right to receive information, enshrined in article 10 of the Convention. European Courts have decided in various cases that the commercial dissemination of information that contributes to public debate on matters such as public health should be subject to less restrictions than pure commercial advertising. Although the Strasbourg Court has not been requested to examine this question, there is a strong argument that objective and factual scientific discussion about life-saving treatments does contribute positively to the public debate on protection of health.
This legal proposal is a good opportunity to strike the correct balance between protecting European patients from undue influence and inappropriate information, but also empowering them with information that could make a real difference in managing their conditions and improving their lives.

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