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Information to patients: the final step?

New legislation on patient information was moving through the European Commission and Parliament over a year ago, but what has happened in the intervening months?

Information to patients - the final stepSome time ago, I wrote about the imminent arrival of new legislation from the European Commission regarding patient information, but nothing has been finalised since. A brief overview of the history of this particular proposal helps to explain a bit more about the tortuous journey so far.

A step towards an EU law on information to patients was taken in 2008, when the European Commission submitted its first proposals to make certain information available to patients across the European Community. The proposals were instantly greeted with hostility from many quarters, including European patient groups and factions within both the Commission and the Parliament.

Events such as changes in presidency or elections in the European Parliament meant that the proposals sat with the institution and, to all intents and purposes, it appeared that the legislation was dead.

Then, suddenly, in November 2010, the European Parliament proposed amendments to the original texts, including a huge twist in a commitment to make information available to the public.

Debate on new texts
The revised proposals set out a clear framework whereby companies with marketing authorisation for a product may – and to some extent must – provide good quality and objective information on their prescription-only medicines to the general public. As a follow-up to the heavy amendments adopted by Parliament, the European Commission withdrew its proposal.

Almost one year later, again with customary urgency, the Commission adopted its revised proposals in October 2011. The next step is for the new texts to be debated by the European Parliament and the Council of Ministers, and, if approved, then to be adopted into European Law. The EU executive, however, presented a third 'version' of the proposals in February 2012. The texts - now two directives and two regulations - represent a technical change meant to facilitate negotiations with stakeholders while the content stays the same.

For those unfamiliar with the process through which proposals become European legislation, here is some background on the decision-making process.

There are three main institutional actors involved. First, the European Commission is the only institution with a legal right to present legislative proposals. Once its proposal is released, the Parliament and Council have equal standing in the adoption process. In practice, this means that the two institutions have to reach a consensus. They have two chances to do so, which are called readings.

If, during the first and second reading, no agreement is reached, a Conciliation Committee is formed from representatives of Parliament, Council and Commission, this being the last chance for the initial proposal to turn into legislation. If the work of the Conciliation Committee does not conclude with an agreed proposal, or if the agreed proposal is then not adopted by the Parliament in session or the Council, then the whole legislative process ends and the Commission must present a new proposal. Moreover, during all this time, if the Commission considers it appropriate, it may withdraw its proposal.

The diagram below summarises the different possible scenarios in the legislative process and helps to explain both the complexity of the procedure and the reason why things can take so long.

The EU's ordinary legislative procedure

The EU's ordinary legislative procedure

Indications from Brussels are that this legislation has finally become a matter of some urgency in the EU legislators' minds.

Finally, it seems that there has been a realisation that the information is out there anyway, but that there is no way of vetting the quality. It is this drive to provide reliable and appropriate information, vetted and approved so that it can be trusted by patients, that is fuelling this renewed interest.

A direct quote from the Commission fully characterises this new awareness that legislators are lagging behind the reality that already exists: 'Patients are increasingly interested in learning more about the medicines they take and want more of a say in how they are treated. At the same time, patients are confronted with a growing volume of information from various sources and often find it difficult to identify reliable information about medicines. The increased use of the internet over recent years makes the need for clarity even more important. Online information on medicines must be accurate and reliable.'

Now that this proposal appears to be nearing reality, it is important to understand fully what its implications could be for the industry, as well as what it means in terms of communicating with patients in Europe.

The key elements of the amended proposals are:

1. There are specific types of information that will be allowed on prescription-only medicines. For instance, such information includes:

  • Information on the label and package leaflets
  • Information on prices
  • Information on pre-clinical tests and clinical trials of the medicine concerned
  • Information on the instructions for correct use of the respective medicine.

2. Only specific channels of communication will be allowed for providing the above-mentioned information.
Examples of such channels are officially registered internet websites or printed information, as long as it had been specifically requested by members of the public.

3. There will be certain quality-related criteria with which all information has to comply: such as the request for information to be objective and unbiased, evidence-based, up to date, reliable, factually correct and not misleading, understandable and clearly understood. At the same time, the needs and expectations of patients are to be met through the provided information.

4. As a general principle, information which has not been approved in advance is to be checked by competent authorities before dissemination. At the same time, information not approved in advance as part of the marketing authorisation has to be pre-approved by the appropriate national authorities before being disseminated to the general public by the company in question. However, there may be cases in which member states cannot allow this due to constitutional issues. In such situations, member states may impose ex-post controls in order to authorise medicines at a national level. Consequently, national authorities may act as a filter between information providers – companies – and information recipients – patients.

With these key aspects in mind, there are still a few questions that are raised by this proposal that are worth considering:
One issue refers to drawing a distinct line between providing information and advertising. It is extremely important to be able to distinguish between advertising and non-promotional information on prescription-only medicines, keeping in mind the interest of providing more and improved information to patients while, at the same time, maintaining the ban on pharmaceutical companies advertising prescription-only medicines directly to the public.

No 'pushing' of information
Another question relates to the possibility of providing information on prescription-only medicines via certain channels of communication, such as television, radio or other media. In this case, the Commission proposal aims to reduce the risk of information being 'pushed' to patients by, generally speaking, not allowing the dissemination of such information via communication channels such as television, radio or the printed press, such as magazines.

On the contrary, the Commission's approach, as set out in these proposals, favours a 'pull' approach, where information is only provided to patients who actually ask for it.

Regarding the suggestion of making information available over the internet, marketing authorisation holders, ie pharmaceutical companies, must register websites containing information about their prescription medicinal products with the national competent authorities of the member states. The registration of websites, coupled with the pre-control and monitoring of information by the competent authorities of the member states, aims to ensure that information made available by pharmaceutical companies to the general public is non-promotional and reliable.

In summary, Europe may finally get some legislation allowing communication of information on prescription-only medicines to the public. While many in the industry will argue that maybe this does not go far enough, perhaps experience in other countries with less rigorous controls argues that this is a sensible start, and certainly far better than the current 'head-in-the-sand' approach to patients obtaining information. Certainly a better and appropriately informed public can only be a positive thing for the future of better treatment in Europe.

Max Jackson, Sudler & Hennessey
The Author
Max Jackson
is CEO at Sudler & Hennessey for EMEA and APAC, as well as chairman of the European Association of Communications Agencies Health Communications Council (EACA HCC).

6th March 2012


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