To avoid unnecessary pressure on the system and to eliminate practices which have an overall negative impact on use of resources, the EGA calls upon the Competent Authorities:

The entry of the generic versions of the medicine has served to significant lower prices for the molecule by providing robust competition. It has also increased the accessibility to Omeprazol for Europe’s patients due to affordability. By preventing and delaying generic competition, market monopoly was unjustifiably extended. The ECJ Decision may now allow public health insurers and generic drug manufacturers who were affected by the company’s behaviour to claim damages.

The Decision comes almost a year after the European Commission adopted the Final Report on its competition inquiry into the pharmaceutical sector. The inquiry concluded that originator companies use a variety of instruments to extend the commercial life of their products thereby preventing generic entry for as long as possible.

“The Commission’s determination to pursue those engaged in anti-competitive practices, together with the impact of the ECJ’s Omeprazol Decision, should help to ensure a fairer market entry for generic medicines so that they can offer affordability and sustainability for Europe’s health services” says Greg Perry, EGA director general.

More information on the AstraZeneca case is available under: http://curia.europa.eu/jcms/upload/docs/application/pdf/2010-07/cp100067en.pdf

"If the patent system is not reformed in Europe, drug manufacturers will encounter increasing hurdles to competition and real innovation." This was the message delivered by Greg Perry, director general of the EGA, in his opening address to delegates at the 6th EGA legal affairs forum on 11 March 2010, in Munich, Germany.

As the follow-up to the pharmaceutical Sector Inquiry gathers pace, the EGA seeks to continue constructive dialogue with the European Patent Office (EPO). The aim is to improve the efficiency of Europe's patent system in line with proposals from the European commission. The EPO must look to improve the quality of patent examinations and applications and accelerate examination and opposition proceedings, the EGA stresses.

It supports EPO proposals to "raise the bar" in this area in order to end patent speculation. THE EGA also backs the introduction of an "Information Disclosure Statement", a requirement for applicants to provide the results of earlier relevant patent office searches to aid the European examination procedure. However, the EGA remains concerned about the possibility of evading EPO rules that limit the filing of divisional applications.

Patent litigation discrepancies across Europe are also problematic. This disparity could be solved by the establishment of a well-balanced, central European Patent Court with technically-qualified, experienced judges. This would create an opportunity to streamline and simplify patent disputes and reduce forum shopping, the EGA believes.

"Patent linkage, which delays the market entry of generics, remains a cause for concern," Mr Perry said. The situation is critical, for example, in Portugal, where some 260 judicial proceedings against generic companies are pending. The EGA supports a legally-certain Bolar provision that would permit all administrative acts needed to market a generic and keep them out of the scope of the patent protection. This includes applying for and receiving a marketing authorisation, price and reimbursement. Mr Perry concluded that "the follow up to the Pharmaceutical Sector Inquiry is now clearly taking place. Recent moves by DG competition to investigate actions that hinder the market entry of generic citalopram* and Spain's move to accelerate pricing decisions for generic medicines were evidence of this."

*The European Commission opened formal proceedings against pharmaceutical manufacturer Lundbeck, citing potential anti-competitive behaviour (Press release Reference: IP/10/8; Date: 07/01/2010)
 

MEPS launched discussion on new controls of active pharmaceutical ingredients (APIS)
3 March 2010

"New controls of Active Pharmaceutical Ingredients (APIs) must be workable, effective and ensure continuous supply of all medicines". This was the key message of Greg Perry director general of the European Generic medicines Association (EGA) at the round table hosted by MEP Judith Merkies and MEP Marisa Matias on "Effective Controls against Falsification in Active Pharmaceutical Ingredients and Excipients" in the European Parliament on 2 March.

Greg Perry reiterated his industry support for enhancing the current audit systems proposed by the European Commission and for the written declaration by the exporting country attesting the ‘equivalence of standards’ to those of the EU.
A common agreement was reached among various speakers on the fact that an EU certification and mandatory inspections systems would unavoidably lead to limitation of ready access to affordable and innovative treatments for EU patients. Participants welcomed that these aspects were not part of the European Commission’s proposal.
Echoing views of other parties in the round table, Judith Merkies said that much has already been done in the EU and that the European Parliament should not overburden operators and authorities in the legal supply chain. "The European Commission proposal builds effectively on current practices. The main focus now must be on how to tackle the illegal supply chain and criminals as they are the main sources of the problem" Merkies said.

The European Commission, represented by Martin Terberger, Head of the Pharmaceuticals Unit at the Health and Consumers DG, expressed its concerns on putting unrealistic requirements on API controls mainly because resources are, to date, insufficient to conduct mandatory inspections. The same remark applies to excipients used in the manufacturing of medicines. Adding to this, Greg Perry declared "Excipients are widely used by other sectors in the EU and most excipients suppliers already operate according to official international quality standards". These observations were also supported by representatives of other sectors of the pharmaceutical industry.

Concluding the event, Judith Merkies and Marisa Matias called for building on existing international cooperation of inspections as the way forward to rationalise resources and avoid duplications of inspections.



EGA calls for improved regulatory framework with vision 2015 to create a stronger European generic medicine industry and increased patient access to affordable healthcare
21 January 2010

Greg Perry, director general of the European Generic medicines Association (EGA) opened the 9th edition of the EGA Scientific and Regulatory Affairs Conference in London, by reiterating the association’s vision to create an improved European regulatory framework for generic and biosimilar medicines. Entitled Vision 2015, the plan aims to meet three main objectives: create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable healthcare in Europe.

Greg Perry emphasised that significant successes had been achieved in the regulatory system since its reform in 2003 but there is clearly room for improvement. “Generic medicines are one of the most competitive sectors in Europe, accounting for almost 50% of all the medicines dispensed, bringing combined savings of between 25 and 30 billion Euros yearly. And yet numerous hurdles crop up as a result of anti-competitive activities that create unnecessary delays in the development and introduction of new generic medicines. Our vision will create a clear, open market that will benefit patients everywhere, spur innovation and generate considerable savings. Some reforms will require new law others can be achieved by better application of the current law." Greg Perry said. 

The EGA believes 5 key steps are necessary to meet their main objectives:

1. Enhance competitiveness of the EU generic medicines industry by introducing more tax and R&D incentives for generic and biosimilar research and clinical trials, as this would further spur innovation within the industry and safeguard the development of the European generic industry as a whole.

2. Eliminate barriers to generic competition by restricting third party intervention in procedures that enable anti-competitive strategies and unjustifiable delays in Market Authorisation. The regulatory process should be free from all patent linkage, and clear regulations should prevent new hurdles such as the “early notice mechanism”. Furthermore, when considering innovation, products with little therapeutic value should be distinguished from real therapeutic innovations. 

3. Introduce better regulation by building on the current success of the European authorisation systems including streamlining the Decentralised Procedure (DCP) and better adaptation of the Centralised Procedure (CP) to generic medicines. Generic applications currently account for 85% of all DCP and 41% of all CP applications.

4. Strengthen single market harmonisation by more strict adherence to the principle of Mutual Recognition - no repeat assessments by Concerned Member States and an enhanced role of CMDh 5. Increase information on generic and biosimilar medicines to patients and health care professionals across Europe. The Association is also pleading for measures to be instated eliminating negative information campaigns, an issue of major concern raised in the recent Pharmaceutical Inquiry. With over 700 companies employing over 150,000 people in Europe, the generic and biosimilar industries are uniquely placed to ensure patient access to affordable quality medicines while helping to control national health expenditures.


Keep in mind the objectives if the EC pharmacovigilance legislative proposals: improving the EU pharmacovigilance system and cutting red tape
20 January 2010

During the ongoing codecision procedure, policy makers must keep in mind the objectives of the European Commission pharmacovigilance legislative proposals which consist in strengthening, but also streamlining and rationalising, the Community pharmacovigilance system with a view to preventing unnecessary patient exposure to risks. 

This was the key message given by Suzette Kox, EGA Senior Director Scientific Affairs, at the EGA’s 3rd Pharmacovigilance Discussion Forum in London today. A number of national competent authorities and the European Consumers’ Organisation participated in the forum. “The Commission’s proposals are welcomed in general, but there are key issues at stake which need to be adequately addressed during the codecision process”, she said. “One of them is the reporting by marketing authorisation holders of all adverse reactions to one single point within the Community, namely the Eudravigilance database; this is a breakthrough proposal and should not be dismantled”. This EU database and data-processing network is the best available Community tool to detect early safety issues by using the maximum amount of information available. 

Another major EGA concern is the introduction of the new “summary of the essential information necessary to use the medicine safely and effectively” which is proposed to be included in the product information. The EGA has major problems with this new section as it will not equally apply to all patients and would thus be confusing and misleading for many of them, introducing new disharmony amongst products with the same active substance and it would also be very costly. “Any proposal should be proven to be of benefit to the patient before it is passed”, Ms. Kox concluded. The draft opinion of the European Parliament Committee on the Internal Market and Consumer Protection calls on the European Commission to come up with reflective proposals regarding the readability of product information within three years of the entry of the new directive.

The on-going discussions also provide an opportunity to clarify the requirements for periodic safety update reports (PSURs) for generic medicines. In line with the proposed risk-based approach, there will no longer be routine PSURs for active substances with a well-established safety profile.  However the single frequency for the submission of the reports for products containing the same active substance will be determined by the relevant competent authority. “Generic medicines will consequently follow the same submission cycle as the respective originator product thus allowing single safety assessment of related products for the benefit of the patient” explained Ms. Kox.