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Pan-European compliance

Marketing drugs across the region provides many challenges, not least of which is the need to remain obedient to a plethora of regulations and codes of conduct
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The promotion of pharmaceuticals across Europe is regulated by the European directive 2001/83/EC as amended. This directive is incorporated into national law in each of the European countries and, therefore, although the directive forms the basis of the law, differences may occur in the way it is interpreted locally.

Self regulation
The promotion of pharmaceuticals is further governed by the pharmaceutical industry's own self-regulatory codes of conduct.

Most countries in Europe have their own national industry association – for example, the Association of the British Pharmaceutical Industry (ABPI) in the UK, the Irish Pharmaceutical Healthcare Association (IPHA) in Ireland and Farmaindustria in Italy. These national associations are members of the European association, the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA produces an overarching code of conduct for Europe, which provides the minimum standards that must be implemented into the codes of conduct at a national level by its members. It is not itself a code under which complaints may be processed (these must be dealt with nationally) or under which national decisions may be appealed.

Variations
Therefore, because the legal and self-regulatory frameworks are the same across Europe, there are many similarities in the way that pharmaceuticals can be promoted in the individual countries of Europe. However, the interpretation and implementation at a national level also leads to many differences. There is also variation in the prominence of the self-regulatory code of practice mechanisms for dealing with complaints relative to regulatory authority actions and inter-company legal action. This can make life complex for those who are involved in producing or reviewing materials and activities for Europe. If these differences are overlooked, significant changes may be required at the national affiliate level before the materials can be used or activities may result in non-compliance and its subsequent consequences.

Core campaigns
Core campaign materials are not normally printed centrally but are sent to the various affiliate countries around Europe for adaptation in order to be compliant with local regulations and self-regulatory codes of conduct. Although the core materials are certified locally before use, there is no point in producing materials intended for pan-European use that can only, in reality, be used by one or two countries without them undergoing radical changes. The aim is, therefore, to produce campaigns that are acceptable in most markets with only minor modification. As a result, it is important that those involved in producing or approving core campaign materials at least consider the key elements of the core campaign and the potential regulatory and self-regulatory differences in the countries in which the campaign will be used.

Data on file … is only allowed in UK, Ireland and Greece, but not normally in most other European countries

Basic principles
There are numerous basic principles which require consideration for core campaigns, as with all national campaigns. However, this article focuses on the specific issues when producing materials intended for pan-European use. Examples of specific country variations are provided below, but this is not a comprehensive list.

Consistency with licence
Depending on the route chosen for the licence application, the product licence may vary across Europe. Therefore, the first step in the compliance procedure must be to confirm that any claims are consistent with the product licence in all of the countries where the promotional material is intended to be used.

Standards of proof
Substantiation is the verification of claims or statements made in promotional materials; this verification is usually achieved by citing references. It is important to find out what types of references are allowed as standard of proof for substantiation of claims, as this varies across Europe. Types of data include:

  • Published data from journals in the public domain is universally acceptable, but some countries prefer peer-reviewed journals
  • Abstracts from data presented at international conferences may be used in UK, Ireland, Greece, Czech Republic, Netherlands, Sweden, Turkey, Germany, Italy and France, if under 12 months old
  • Posters presented at international conferences may be used in UK, Ireland, Greece, Czech Republic, Netherlands, Sweden and Turkey
  • Data on file – i.e. not in the public domain – is only allowed in UK, Ireland and Greece, but not normally in most other European countries, unless it was submitted as part of the regulatory dossier.


Visuals, images and words
Promotion should be carried out in such a way that it recognises the special nature of medicines and, furthermore, they must not be promoted in the same way as consumer goods. Companies must maintain high ethical standards and recognise the professional standing of the recipients. The promotion must not cause offence; this can be a difficult area to get right, as the subjects and images that may cause offence vary around the world.

An example of this may be images of female body parts used in advertising, which may be acceptable in some countries but not in others. Therefore, at the concept stage confirm that proposed visuals/images would be acceptable in the countries where the material is intended for use.

Additionally, the words used in the promotional claims that are acceptable in English may not be acceptable and have an entirely different meaning when translated into other languages. It is therefore extremely advisable to check with staff from the affiliate country at this stage.

Pre-approval or submission to competent authorities
In some European countries, it is a requirement for the materials to be pre-approved or submitted to the ministry of health within a certain time-frame. For example, Italy operates a negative clearance system which requires the submission to Italian Medicines Agency (AIFA) ten days prior to use. In France, materials must be submitted to the French Agency for the Safety of Health Products (AFSAAPS) within eight days of use, while the UK only requires the pre-approval of materials for new chemical entities for six months or if serious breaches have occurred in the past.

Market research
Market research, although mentioned in a number of the codes, is not normally considered promotional if conducted correctly. Care must be taken to ensure that the market research and the materials used in it are non-promotional, otherwise it may be considered disguised promotion. The results of the market research can be used promotionally in some countries but not in others, such as Turkey. Therefore, if considering using market research promotionally or carrying out market research on advertising claims, individual country rules regarding this should be checked.

Even when all of the above have been considered, it will not be possible to ensure that a campaign will be acceptable in all countries where it is intended for use. Therefore, it is extremely important and mandatory in most countries that the marketing campaign should be reviewed, approved and certified for use locally.
Promotional activities are regulated as follows:

International Congresses
According to European law, a medicine must not be promoted in a European country prior to the grant of its marketing authorisation (MA) or outside the terms of the licence, for example, for an unlicensed indication or dose, pertaining to the country where the promotion is to take place.

Despite the difficulties that these differences create, many companies are producing core promotional campaign materials or planning activities centrally, because of the advantages

One exception to this rule is that in some countries, such as UK and Ireland, it is possible to promote a product or indication which is unlicensed, or off-label, from a booth at international meeting of a high scientific standing organised by a bona fide third party, providing certain other conditions are also met, relating to the relevant codes of conduct.

This exception does not apply to most other European countries, such as Germany and France, where it remains against the law to promote a product either outside the terms of its licence or which is unlicensed even if it is an international congress and the product is registered elsewhere.

Prior permission
In some countries, when engaging 'state employees' (e.g. hospital doctors) as consultants or providing hospitality, pharmaceutical companies must ensure either that prior permission has been granted by the healthcare professional's employer or that the regulatory authorities have been notified.

Here are some examples:

  • In Belgium, a prior 'visa' from the regulatory authorities is required for overnight stays
  • French physicians or pharmacists who receive partial or total funding of travel/accommodation expenses need to submit the request for funding to Conseil National de l'Ordre Médecins (CNOM) for doctors, and Conseil National de l'Ordre Pharmaciens (CNOP) for pharmacists
  • Italy requires notification to the Italian Medicines Agency (AIFA)
  • Netherlands requires that if the hospitality provided to Dutch healthcare professionals is outside the Netherlands, then the CGR (Netherlands self-regulatory authority) must be notified
  • In Sweden, approval is required by the Swedish Association of the Pharmaceutical Industry (LIF).


However, despite the difficulties that these differences create, many companies are producing core promotional campaign materials or planning activities such as international congresses or promotional meetings centrally, because of the advantages in cost savings, consistency of messages and branding.

The key to remaining compliant in this challenging and varied environment is to be aware of the pitfalls outlined here but, above all, to plan project activities well in advance and involve all stakeholders both at the affiliate level and in head office.


Dr Judith GriceThe Author
Dr Judith Grice
is managing director at PharmaCodes Compliance

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3rd November 2011

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