EGA Press Release

Monday, 10 February 2003

G10 Workshop Identifies Key Measures to Stimulate Generics

Increasing generic prescribing, generic dispensing, and consumer awareness in generic medicines, as well as introducing more competitive price systems are the key stimulants for increasing generic competition in the EU. However, failures in the EU regulatory system, in particular disharmony of the SmPCs of reference products, and the increasing use of indications patents, are creating major problems for the marketing of generic medicines. Introducing data exclusivity for so called “new” indications would severely add to this problem.

These were the main conclusions of the G10 High Level Group on Medicines Workshop on Generic Medicines jointly organised by INFARMED (Portuguese Medicines Agency) and the EGA (European Generic medicines Association) in Lisbon on 31 January 2003.

The workshop was held to pursue the objectives of G10's Recommendation 4, which called upon EU Member States to secure the development of a competitive generic market(1), in the European Union. Opening the workshop, Luís Filipe Pereira, Portuguese Minster of Health and Member of the G10, stressed his Government's commitment to increasing the availability of generic medicines in Portugal.

Generic medicines are targeted to represent 8% of products dispensed in Portugal by the end of the year. Although still small in comparison with some other EU states such as the UK, Germany, Holland and Denmark(2), this represents a significant increase from the low point of less than 1% two years ago, and much higher than in Spain where generics have not made a significant impact. A new electronic prescribing system for practitioners, to be launched later in the year, is expected to facilitate generic uptake.

The G10 workshop identified a number of measures that EU Member States should consider for stimulating the availability of generics. These included:

• Educating doctors to use generic medicines and where appropriate the INN.
• Assisting doctors in understanding the economic implications of prescription decisions.
• Increasing the use of electronic prescribing.
• Creating substitution lists.
• Increasing incentives for generic dispensing and substitution (regarded as particularly important in systems where doctors are not economically sensitive).
• Improving consumer awareness of generic quality and availability.
• Increasing pharmacoeconomic evaluation of new products in comparison with existing products.
• Establishing generic-oriented reimbursement and health insurance systems.
• Adopting reference pricing and free pricing systems instead of controlled price systems.
• Reducing the time delay between receiving market authorisation for a generic product and gaining pricing, reimbursement and/or substitution status.

However, workshop participants stressed that registration and use of generic medicines are being hampered due to a lack of EU harmonisation in indications of reference products (i.e. original products) on which generic applicants must base a common European-wide approval. Many felt that the problem will worsen as patents on particular uses become more frequent and if data exclusivity is granted to so-called “new” indications, as this will increase the differences in use for the same molecule produced by different companies and thus prevent generic market approval or substitution/reimbursement status.

“It is clear that securing the development of a competitive generic market in the EU requires appropriate measures both at Members State and EU level. Whilst there is some evidence of action at Member State level, our concern is that this progress is being hampered by the current EU registration system,” concluded Rory O'Riordan, President of EGA and Member of the G10.

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(1) Member States—facilitated by the European Commission—should explore ways of increasing generic penetration in individual markets (including generic prescribing and dispensing). Particular attention should be given to improved market mechanism in fill respect of public health considerations.

(2) • Germany 21% value / 36% Volume • UK 18% value / 52%Volume • Denmark 35% Value / 60% Volume • Spain 3.8% volume / 3,3% value •

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