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Regulation review

How has the past five years shaped pharma, and what does the future hold for the next five?

To commemorate five years of Pharmaceutical Marketing Europe, we asked Tim Worden at Taylor Wessing for his thoughts on significant regulation that has come into force during the past five years, as well as what he predicts will be the key areas for regulators in the next five years.

The past five years
From a regulatory perspective, one of the biggest changes in the last five years was the introduction of the new Community Code relating to medicines. The new Code amended the first consolidation of regulatory legislation, which was carried out by the European Commission in 2001.

Some of the main issues addressed by the new Code are:

the introduction of a streamlined 'decentralised procedure' for the authorisation of medicines

the need to facilitate entry onto the market of generic medicines, while encouraging continued R&D by innovator companies

the need for clear Patient Information Leaflets (PILs).

Generics entry
The entry of generic medicines onto the market has been facilitated by the introduction into European law of the 'Bolar' provision. In essence, this provides that conducting such clinical trials as are necessary in order to apply for a generic product marketing authorisation shall not be regarded as infringing an innovator's patent.

In return, innovator companies benefited under the new Code from a harmonised 10 year 'data exclusivity' period across the Community. The data exclusivity period is the period of protection awarded to data filed by an innovator company in support of its application for a marketing authorisation.

During that period a regulatory authority cannot make reference to such data to process an application for a generic marketing authorisation. Prior to the new Code, data exclusivity periods had varied across Europe, being either six or 10 years.

The new 10-year period comprises eight years of data exclusivity and two years of market exclusivity, meaning that a generic company can rely on innovator data in applying for a marketing authorisation for their generic after eight years, but cannot place their product on the market for a further two years.

Patient information leaflets
In relation to PILs, by 1 July 2008 the patient information leaflets of all medicines marketed in the EU must have been tested on potential patients to ensure that they are clear and easy to use.

The next five years?
Biosimilars - generic versions of biological medicinal products - are undoubtedly going to be in the spotlight from a regulatory perspective. Fundamental differences between small molecule medicines and biologics, and the fact that the first biologics are coming off patent, mean that the Commission will have to continue to grapple with how biosimilars should be regulated.

Another issue is the advent of advanced therapy medicinal products - products based on gene therapy, somatic cell therapy and tissue engineering. The Commission has introduced the Advanced Therapy Regulation relating to the authorisation of such products, which shall apply from the end of 2008. As the development of these advanced therapies progresses over the next few years, a number of regulatory challenges will undoubtedly arise.

Communicating to patients
Consultation is currently underway on the provision of information on medicines to patients. The aim, among other things, is to provide equal access to such information for patients throughout the EU. The Commission is clear that the ban on advertising prescription-only medicines to the public will remain, but the increased ability for pharmaceutical companies to communicate with patients no doubt represents an interesting opportunity.

Increasing scrutiny
Finally, there is the matter of scrutiny. Pharma faces increasing attention from regulators, governments and the public. The Commission is carrying out an investigation into the industry, with a particular focus on concerns relating to the delaying of market entry of generic medicines. An interim report is due in autumn this year. It remains to be seen how the pharmaceutical industry will fare in an increasingly challenging environment over the next five years. At this stage, however, one thing is for sure - the level of regulation is bound to increase.

The Author
Tim Worden
Associate, Taylor Wessing

8th July 2008

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