EGA PRIORITIES 2007
12th
ANNUAL EGA MEETING
21-22 September 2006 — Budapest
CONFERENCE SUMMARY REPORT
Greg Perry, Director General of the European Generic
medicines Association, Outlines the Association's Top 10 Priority Areas by
way of summarising the 12th EGA Annual Meeting in Budapest.
- International Non-proprietary Name (INN)
for Biosimilars – The EGA has
welcomed the European Commission’s approval this year of two biosimilar products
and are particularly encouraged by the European Medicine Agency’s interpretation
of the science underpinning these applications as demonstrating equivalent
therapeutic effect to the reference product.
But while vindicated in our belief in the ability of science to demonstrate comparability, the EGA remains
concerned that this new generation of affordable medicines may not reach
patients as quickly as possible. We will make every effort to overcome the
numerous barriers that delay the access of patients and healthcare systems
to high quality, lower cost versions of these life-saving medicines. The
EGA will continue to work in 2007 to:
- Ensure that biosimilar products are entitled to carry the same INN as the reference product;
- Implement reliable and efficient mechanisms to ensure the traceability of all biological medicines, including biosimilar products;
- Pave the road at national level for pricing, reimbursement and substitution status, and to ensure the interchangeability of biosimilar medicines.
- Pharmaceutical Forum – The EGA is actively committed to the success of the Pharma Forum and to achieving a more transparent and sustainable environment for generic medicines. Through the Forum the EGA will work to seek greater commitment from governments for measures to increase patient access to generics, particularly by reducing time delays for access to markets and by dealing with market distortions caused by specific regulatory and patent issues.
We will continue to support “real rewards for real innovation”,
ie, for products which bring significant therapeutic improvements or added value
to patients, and for stronger generic competition under European pricing and
reimbursement systems. Similarly, the EGA will seek to encourage headroom for
competition and the sustainability of the EU generic medicines industry while
working with governments to improve information on the quality, safety, efficacy
and economic advantages of generic and biosimilar medicines to European patients.
- Implementation of the New Medicines Legislation - The Bolar provision has been implemented differently in various Member States which is liable to bring about unfortunate developments in this area as originators may try to use the courts to limit the impact of the Bolar provisions. If they do, the legislation will more than likely not be as successful as intended, as it was clearly aimed at getting generic products onto the market as quickly as possible after patent expiry.
- Patent Linkage - We have been relatively successful in stopping the spread of patent linkage. The fact is, Member State agencies do not want it, and neither does the Commission. It is not compatible with EU law and we have made a formal complaint against the Slovak Republic for its inclusion of a patent linkage clause in its medicines legislation. This will be a case to watch closely. Internationally, patent linkage is being pushed by the United States Trade Representative (USTR), and we are cooperating with and advising generic associations elsewhere in the world on how best to oppose these efforts.
- Generic Penetration levels are
unsatisfactory in many countries, and EGA will work to improve them throughout
Europe. Certain countries clearly need a special, dedicated effort in this
respect. At the top of this list are Spain and Italy. Progress has been made
in France, but there is still much more to be done. Belgium is another country
that needs more attention, and the recent introduction of partial tendering
is particularly discouraging.
The Simoens Report has
identified where improvements can and must be made, and we will be discussing
these measures with the various governments involved. The Simoens Report was
particularly clear on one point: for the generic industry to be sustainable and
capable of providing the price advantages and competition required by governments,
the industry must to have a large volume of the post -patent market. This is
simply not the case in Spain, Italy, Belgium and France. The EGA will be encouraging
Europe’s generic “underachievers” to set themselves a minimum target of 30% of
the packs sold in their pharmaceutical markets to be generics by 2009.
- Stronger Patent Criteria - The EGA is fully committed to patent protection and believes that it is an important stimulus to innovation. However, we are concerned about how the criteria for granting patents is being applied and about the review and granting process in general. We would like to see a more rigorous assessment of patents, particularly for the inventive step.
- Reduced Time Delays - We have seen in our internal annual report that the problem of time delays for access to the market after a product has received market authorisation continues to disrupt the generics industry. This is particularly true in the numerous Members States where it is not possible to go to market until a price, reimbursement and possibly even substitution status has been granted, and these can usually only be obtained after market authorisation. This cumbersome process can delay the launch of a product by as much as to 12 months.
- Effective Decentralised Procedure - Although the procedure only came into effect last November, generics firms are already experiencing significant delays, with some agencies asking applicants to wait nine to twelve months for the procedure to actually start. The EGA is urging the CMDh to carry out an internal inquiry into these delays and to make its findings public. We are also seeking a meeting with the CMDh to discuss our concerns.
- Anti-counterfeiting - While counterfeiting of medicines almost exclusively effects high-priced originator products with high profit margins, putting an end to this practice is the responsibility of everyone in the pharmaceutical industry. It is important that counterfeit medicines not be allowed to endanger the lives of those who unwittingly fall prey to them, and that they not be allowed to destroy patients’ confidence in medicines and in the public healthcare system.
The EGA will work to move beyond solutions which depend on expensive technology that must be constantly up-dated to thwart manipulation and security breaches. Instead, the EGA will push for the adoption of a behavioural paradigm designed to ensure that the entire pharmaceutical industry does “Business with Certified Partners Only.”
- Overall, the EGA will work to create a suitable environment for generic medicines so that our industry can continue to meet society’s need for a reliable supply of affordable quality medicines. The generics industry is presently facing serious challenges through heavy price reductions, realignments in the industry, increased costs from new regulations, anti-competitive activities of originators, and from competition from outside Europe that is placing unprecedented pressures on the industry.
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