Legislation to Provide for Generic Substitution of Prescribed Drugs and Medicines
The Government is expected to introduce legislation providing for a system of reference pricing and generic substitution for prescribed drugs and medicines under the General Medical Services (GMS) scheme and community drug schemes. The Department of Health has confirmed that it is preparing the Health (Pricing and Supply of Medicines) Bill which is due to be published this year. The Bill is intended to promote price competition among suppliers and to increase the scope for savings for patients through the greater use of generic medicines.

Biosimilar Guidelines Overhaul
The European Medicines Agency has recently published a concept paper recommending a review of its guideline on Similar Biological Medicinal Products published in 2005. The paper advises that the guideline should be revisited in light of how biosimilars are currently being developed. The concept paper identifies a number of issues for consideration including:

• Whether the principles of biosimilarity should be clearer
• Whether a definition of “biosimilar” should be introduced as the term is often used in an inappropriate way
• The equivalence of efficacy and safety aspects
• The possibility of having the same pharmaceutical form, strength and route of administration for biosimilar products and reference medicinal products
• The utility of the current guideline lists of references, some of which are outdated

Once feedback is received on the concept paper, a revised draft guideline is expected to be released later in the year for further consultation.

European Medicines Agency: Electronic Submission of Information on Medicines
The European Medicines Agency’s new system of electronic submission of information on medicines is being introduced on a phased basis. The purpose of the new initiative is to create a list of all medicines authorised and registered in the EU, to identify medicines accurately and to strengthen the EU safety monitoring system for medicines. (To view a previous article on this, please click here.)

The first phase was the publication in July 2011 of the format for the notification of the electronic submission of medicinal product information. The format lists all of the data elements required. The format was updated in September 2011 to include the XML Schema Definition (XSD) for the individual data elements.

Phase two involved electronic submission by marketing authorisation holders using tools developed in-house by pharmaceutical companies or software vendors. It is expected that by the end of January 2012 marketing authorisation holders will be able to use data-entry and submission tools provided by EMA.

Phase three involves EMA, with the assistance of a contractor, processing and validating the information submitted to ensure that it is accurate and up to date.

It is intended that the final phase will be carried out in 2014 and will involve updating the July 2011 notification format in line with the International Organisation for Standardisation (ISO) Identification of Medicinal Products standards. Marketing authorisation holders will not be required to resubmit data previously provided, but may be asked to provide updates based on additional ISO data elements not included in the July 2011 format.

Contributed by Mary Drennan and John Magee.