Veterinary Market – How Innovative?

European veterinary market of new medicinal products noted  a dynamic growth over the past 20 years. EU regulations - numerous at that period of time - were smoothly implemented. But what is more significant – veterinary market efficiently resisted the economic slowdown. It is important to mark that such a good condition of the branch is a result of intensive growth of generic medication’s share in the whole sale and not because of the market dominance being built through innovative medications. The main cause of that situation is  lack of sufficient intellectual property protection.

In a modern pharmaceutical industry – including the veterinary sector – innovative products are one of the main factors determining the market success of the company. They should be a firm basis of competitiveness in a long term perspective. Most of the companies notice the real chances resulting from investments in innovative solutions – new molecules, indications or even new animal species, to which the product is dedicated. Despite this, the number of new innovative products which entered the EU market decreased by over 85% in less than 5 years (51 in 2006 and 7 in 2010). At the same time the number of generic registrations stayed at a relatively steady level.

Legal regulations that were implemented in the past twenty years create a hospitable environment for companies in the EU Member States whose business model relies on generic medications. The negative thing is that they do not ensure a sufficient support for research & development operations at the same time. Changes implemented in 2004 (Directive 2004/28/EC ) are especially important. The general level of intellectual property protection for referential products has been decreased since then. Let us remind that currently that security lasts 10 years (8 years of IP guard and 2 years of market guard). It is worth mentioning that regulations regarding both animal and human medicaments have the same legal base, amended between 2001 and 2004. However, there are fundamental differences between those two sectors. First of all, it is significantly harder to achieve a return of investment in animal life industry in case of smaller market segments like rare diseases, less popular species of animals of basically lesser Member States. It makes the protection of intellectual property much more substantial for implementing the innovative solutions. Moreover, it seems that the authors creating the directive had only one species in mind – namely human – which in case of variety in veterinary industry drastically increases the costs of including new species, to which the product can be dedicated.

European animal health market is a part of global market with 33% share in it nowadays. It locates Europe in the second place with a considerable loss to the north American market (almost 50%). In recent years the number of European entrepreneurs demands for changes in legal regulations have been increasing. There is a need for assuring balance between generic sector and the one basing on research and development. Those changes would eventually lead to improvements in  competitiveness of EU companies. Companies, that feel the Asian concerns’ – which have noted constant growths in recent years - breaths on their necks but then again they do not want to increase the distance between them and America.

One of the proposed solutions – enthusiastically acclaimed by the animal health industry – is the implementation of common veterinary procedure. Practice that would include one scientific evaluation, one registration dossier and one decision allowing sale in all EU Member States. We can only hope that the savings - to which the solution mentioned before undoubtedly leads – will be used by European producers to develop innovative products even in a small fraction.

It is worth pointing that all of the hot issues from veterinary sector you can find on next edition of BioForum in Budapest.

BioForum - Central European Forum of Biotechnology & Innovative BioEconomy and the accompanying events will take place on 22-23^rd May 2013 in Budapest. The originator and the main organizer of this event is a polish company: Bio?Tech Consulting (www.biotechconsulting.eu).

More on: www.cebioforum.com