Press release

IFAH-Europe Buffet Reception
Brussels, July 7, 2003

1.      Welcome and Introduction

by Jean-Louis Delforge, DVM, Chairman, IFAH-Europe Council

Members of the European Parliament, EU Council Working Party, Committee of Permanent Representatives, European Commission, Representatives from national Ministries and other organisations and Colleagues from the Animal Health Industry.  Ladies and Gentlemen, good evening to all of you and welcome to the IFAH-Europe reception.

As Chairman of the IFAH-Europe Council, I will briefly introduce our federation. I will then leave the floor to Mr. Rick Clayton who will present the Animal Health Industry’s views on the current European pharmaceutical legislation review.

IFAH-Europe, formerly FEDESA, represents the national Animal Health Industry associations and the pharmaceutical corporate members established in Europe.

15 national associations and 16 companies are direct members of IFAH-Europe. An additional 186 SME are also member of the same national associations and take an active part in the IFAH-Europe programmes as well, across Europe.

All together, these companies cover more than 95% of the European market for Veterinary Medicinal Products.

IFAH-Europe has been specifically mandated by all of its members to represent their interests vis-à-vis the institutions of the European Community and its relevant agencies and bodies.

The European Union represents about 1/3 of the international market for Veterinary Medicinal Products. It is a very important place of investment and activities for our industry.

Our members have headquarters, Research and Development facilities, production units and marketing functions in Europe. Many of them export across the world.

Equally, Europe is an important regulatory centre that generates regulatory and social policies which not only impact member countries, but which also have high international significance.

Our priorities in IFAH-Europe are in Regulatory Affairs, comprising the element of Regulatory Process Efficiency as well as in the Food Chain.

The Animal Health Industry is small in comparison to some other sectors but IFAH-Europe would like to ensure that the contribution of our industry to the quality of animal and human life is understood by society at large.

We aim to achieve a balanced regulatory and trade framework that motivates innovation while recognising the social and political environment.

And, we encourage constructive dialogue with governments, policy makers, and the other stakeholders.

We are honoured by your presence this evening and really believe that a constructive exchange of views on the review of the European pharmaceutical legislation as it stands today, will lead to further understanding and agreements between the parties involved.

This legislation will shape our future and is of the utmost importance to our industry.

Sound scientific and realistic approaches are essential. They should also meet the practical conditions and the diversity of the European Animal Health market environment.

We all aim at the increased availability of Veterinary Medicinal Products that are registered, effective and safe and that are easily accessible through the nationally authorised routes of supply and through appropriately qualified persons.

They should also remain affordable to the animal owners.

The Review of the European Pharmaceutical Legislation has been well advanced, in particular during these last few weeks. It is at a critical stage for all of us.

I would therefore invite my colleague Mr. Rick Clayton to share with you the IFAH-Europe views on this important subject.

Thank you for your kind attention.

2.      Overview of key points for discussion – perspective of industry

Rick Clayton, Technical Manager, IFAH-Europe

Good evening ladies and gentlemen. I would like to give a brief overview of what we would like to talk about this evening in connection with the review of the pharmaceutical legislation. Of course you may have other questions relating to the regulations for veterinary medicinal products, and this gathering of 7 different nationalities from industry, politicians and member state permanent representatives provides an ideal opportunity to seek more information from various perspectives. 

Now onto industry’s view of the proposals for revisions to the pharmaceutical legislation:

(Message 1)

The 1st point to remember is the Commission did an excellent job in finding a set of proposals to balance the various needs of the different interested parties.  They should be congratulated. The 2nd worth noting is the European Parliament provided valuable input last year by refining the proposals from their broad viewpoint, and very much with the interests of the patient in mind, but also recognising the needs and value of industry’s contribution to animal health and welfare. And thirdly, the Council have just completed a detailed review of the technical practicalities of the proposals, and will certainly have added further improvements.

The out come of this is that most of industry’s concerns have been addressed to some degree.  But there are some very important points still to be resolved.

(Message 2)

Perhaps the most overriding message to come out of the debate over the last 2 years, is that the veterinary sector is very different from the human medicines sector.  Our customer needs and market forces are very different.

Therefore, although veterinary medicines are currently manufactured to equivalent standards of quality safety and efficacy, quite often it is not appropriate to automatically transpose human medicinal rules onto the human sector.

(Issue 1 – Scope of CP)

Thus, we need different set of rules for the compulsory use of the centralised procedure.  And our message here is to urge Parliament to adopt the change proposed by Council whereby it will not be compulsory for veterinary medicines containing new active ingredients to be registered via the centralised procedure.  The problems of our market mean we need an appropriate level of flexibility in the rules here.

(Issue 2 – Data protection)

Again, on data protection, we need a tailored set of rules, to better fit the unique characteristics of the veterinary sector, where we have to consider a variety of species and also consumer safety for farm animal medicines.  Compared to the human sector we have a greater ratio between the investment needed to develop a new medicines, and the potential to obtain a return on that investment from the market place.  Data protection is critical to support more investment in innovation in our sector.

We have a medicines availability crisis.  What our sector needs is more investment in new medicines, not faster access to the market generics – how will copies of existing medicines help? New products are the future legacy for the generics industry – therefore everyone one wins from data protection and innovation.  There are better ways to help the generics industry than by undermining data protection.  Therefore again, we urge Parliament to carry forward the proposals made by Council, which are a compromise between the EP and Commission. 

(Issue 3 – Renewals and pharmacovigilance )

On renewals, industry in the veterinary sector has an even stronger view that human medicines, simply because we must operate within much tighter research budgets.  Renewals can tie up resources – both manpower filling in forms and compiling a renewal dossier, but also R&D cash if new data is requested.  The company then has to choose – is it worth reinvesting in this product, or is the money best spent on developing the new product?  40% in defensive R&D versus 17% in USA. 

Industry is committed to all initiatives to reduce pre-registration data requirements and replace this with more reliance on pharmacovigilance data – more targeted and more efficient means of reviewing product safety = less products removed unnecessarily = less wasteful.  Best practice guide

(Issue 4 – POM for products for food-producing animals )

And finally the issue of prescription only medicines for food-producing animals.  Industry is not against a category of POM products.  The majority of products in all Member States are already POM.  All antibiotic products are already POM. But making everything POM just goes too far, and we cannot see a good justification for this.  The evidence indicates that this is not a consumer safety issue. The Commission explanatory memorandum mentions withdrawal periods on the label.  Farmers are professional, and are all literate and capable of reading the label, and are used to abiding by withdrawal periods; as the residue surveillance data shows – there are no problems. 

The definition of medicine is too broad, and products that simply do not need a prescription will be included; the definition of prescription is not harmonised.  This will create problems, for no good reason.

Industry consider that the Commission did an excellent job when it drafted the existing article 67: it contains a list of criteria that define when a product should be prescription only.  This is an effective system, and has worked well for many years in the member states.  Member states have established their systems around this legal framework.  The current proposal is to prepare a list of criteria by which products may be exempted from the requirement to be POM. 

Therefore our message to Parliament is please reconsider your original amendment 43; industry support the status quo; industry are not opposed to the concept of a list of exclusion criteria.  However industry cannot be expected to support this concept unless the list is prepared upfront.

Thank you for listening.  I hope you will now take the opportunity to discuss these issues with your colleagues from the Council, from the European Parliament, and from IFAH-Europe.

Photographs of the reception