Ireland: Reform of EU Pharmaceutical Legislation

On 18th July, 2001 the European Commission announced proposals for a comprehensive reform of the current EU Pharmaceutical Legislation. The proposals concentrate on the national and Community-wide authorisation procedures for human and veterinary medicinal products.

Specifically, it is proposed to further update Regulation 2309/93, which provides for a centralised registration procedure for specified human and veterinary medicinal products valid throughout the 15 Member States. This procedure will continue to be administered by the European Agency for the Evaluation of Medicinal Products (EMEA). The Commission also intends to introduce two new Directives which will harmonise application procedures in all Member States for the authorisation of human and veterinary medicinal products respectively. The intention behind the Directives is to ensure that these pharmaceutical products are marketed under identical conditions of use across the Community. The Directives will also allow for applicants and national regulatory bodies to draw upon the expertise of the EMEA prior to and during the application and evaluation process.

The original Regulation established a centralised regulatory procedure for the authorisation of certain identified medicinal products for human and veterinary use, as well laying down guidelines for supervision and pharmacovigilence of such products. Responsibility for administration of the application and supervisory process was devolved to the European Agency for the Evaluation of Medicinal Products (EMEA). This will continue to be the case under the new proposals and, indeed, the role of the EMEA has been strengthened/expanded in certain key areas.

The following are the main reforms proposed:-

• The categories of medicines which are to be the subject of a Community-wide authorisation will be expanded.
• The time period for the examination of and decision on an application is to be shortened.
• An additional fast-track procedure is to be introduced to provide for an accelerated assessment procedure for medicinal products of major interest from the point of view of public health and therapeutic innovation.
• The requirements for documentation and information to accompany an application are to be amended in line with the requirements of the Human Use and Veterinary Use Directives.
• A medicinal product which is not yet authorised may nevertheless be made available to patients on compassionate grounds, subject to certain conditions.
• The ten year period of protection for the use of data relating to proprietary medicinal products will be maintained, however a balance will be struck between the protection afforded to the holders of these proprietary rights and producers of generic medicinal products.
• The period of validity of the authorisation, once granted, is to change.
• There will be increased obligations on all parties (authorisation holders and regulatory authorities) in relation to monitoring and reporting adverse effects of products in application ("pharmacovigilence").
• An authorisation may be granted subject to specific obligations, in which case the authorisation will be valid for renewable periods of one year ("conditional marketing authorisation").
• The committees of the EMEA, who form the backbone of the operation of the EMEA, will be strengthened. The Regulation also envisages the establishment of a Committee on Herbal Medicinal Products when these products are eventually separately regulated within the Community.

The EU has been moving towards a common legal framework for the production, authorisation and marketing of medicinal products for the last 40 years. In addition to a centralised procedure for the authorisation of specific drugs (culminating in the proposed reforms of Regulation 2309/93), the procedures for national authorisations have been gradually harmonised and the scope of the matters which are regulated to a Community-wide standard has increased. The draft Directives on Human and Veterinary Medicinal Products (to be commonly known as the "Human Use" and "Veterinary Use" Directives) seek to capitalise on previous measures which have established common national procedures and criteria for the authorisation of medicinal products as well the mutual recognition of such national authorisations. The proposed Directives apply to the substantial majority of medicinal products which are marketed or proposed to be marketed within the Community.

• Identify the range of products which will be subject to national authorisation under the newly harmonised rules.
• Provide for harmonised rules on marketing authorisation licence procedures, time limits for decisions on application, duration of authorisations, pharmacovigilence, packaging and labelling requirements, advertising of pharmaceuticals, classifications of prescription and non-prescription drugs, mutual recognition procedures between Member States and on revocation, suspension or variation of authorisations.
• Confirm the applicability of the 10 year protection rule for data relating to proprietary medicinal products.
• Harmonises the procedures in relation to homeopathic medicinal products, including designating a simplified registration procedure for certain types of homeopathic products.
• Harmonises the grounds upon which manufacturing authorisations must be sought and the procedures for the granting of such authorisations.
• Harmonise rules in relation to the wholesale distribution of medicinal products and the authorisation procedures which relate to such activities.

One of the more controversial aspects of the Human Use Directive relates to the implementation of a pilot information system on authorised pharmaceuticals relating to diabetes, AIDS and respiratory diseases such as asthma. The rationale of the Commission in this regard is to allow for the provision of strictly controlled information on chronic diseases where there is a strong patient demand for such information. The provision will also allow the European pharmaceutical sector to compete with US industry, who are currently authorised to disseminate such information via the Internet.