Nearly two years after they last voted on amendments to the draft regulations on veterinary medicines and medicated feed, MEPs will once again get their paws on this important dossier impacting on the health of Europe’s animals, as trilogue negotiations start following an in-depth review by the Council.
This legislative package will not only impact on animal health of course. For Europe’s nine million+ livestock farmers, access to a wide range of animal medicines can help to optimise herd health management and animal welfare, while ensuring more efficient use of natural resource inputs, key elements of recent discussions on the sustainability and future of farming.
Improved availability of animal medicines can also help Europe’s 70 million pet-owning households keep the animals that share their homes happy and free from disease.
Over the past decade, fewer new disease prevention and treatment options have been made available – or are sometimes not species-adapted - for the many different animals that exist in all parts of Europe.
This is mostly due to high costs for licencing such products, linked to increasing data requirements and administrative burden, and lack of harmonisation across Europe under the current rules governing animal health products.
Since the introduction of the 2004 Directive on veterinary medicines, investment in new product development has decreased significantly, by 20 per cent. When questioned about the most impacted business decisions following the 2004 review, 100 per cent of surveyed companies said EU Regulations have had the highest impact on reduced product range and reduced coverage of species in Europe.
Revising the current legislation on veterinary medicines can help turn this situation around, but making sure that the new rules are equipped to handle future eventualities is a complex task, requiring a lot of time and expertise to ensure an adequate review of what issues are at stake.
"For Europe’s nine million+ livestock farmers, access to a wide range of animal medicines can help to optimise herd health management and animal welfare, while ensuring more efficient use of natural resource inputs, key elements of recent discussions on the sustainability and future of farming"
Back in 2010, the European Commission conducted a public consultation with the aspiration of devising better regulation by putting in place a simpler legal framework. And after nearly four years of studying the issues and reviewing with stakeholders and experts, the European Commission published a draft proposal for the new rules in September 2014.
The proposal outlined that it aimed to: increase the availability of veterinary medicinal products; reduce administrative burden; stimulate competitiveness and innovation; improve the functioning of the internal market; and address the public health risk of antimicrobial resistance.
The European Parliament and Council began their review of the proposed texts at the end of 2014, with the Parliament agreeing on a number of amendments in March 2016.
The Council deliberations continued well into 2017, and there were smatterings of impatience expressed on occasion, but the Estonian Presidency took up the dossier with vigour in the second half of the year and the mandate was agreed for trilogue negotiations with the Commission, Parliament and Council to begin onwards of January 2018.
New rules must consider future animal health concerns and keep medicines availability for treating and preventing diseases in animals to the forefront, AnimalhealthEurope and its members are working alongside the EU institutions to ensure the new framework is better-tailored to the needs of Europe’s farmers and pet owners, as well as to the specificities of Europe’s animal health sector.
"New rules must consider future animal health concerns and keep medicines availability for treating and preventing diseases in animals to the forefront"
As with any innovative business, the industry can only effectively operate in an environment which gives companies the confidence to invest in the research and development of new products and technologies.
The current administrative burden involved in bringing veterinary medicines and vaccines to market under today’s EU regulatory framework is, to put it bluntly, not stimulating innovation, so this needs to remain a central focus of the revision.
The updated legislation must streamline procedures and so relieve some of the administrative burden, while also speeding up the entire process of bringing innovations to market.
By rewarding investment in innovation through improved protection periods for technical documentation, harmonising processes for registering and authorising medicines, and by taking science-based decisions in the interests of animal health and welfare, the animal medicines industry can ensure its response to Europe’s need for new and improved disease prevention and treatment options.
Simply put, by putting in place legislation that is conducive to innovation, we will be in a significantly better position to invest more in research and development.
This would lead to a wider availability of more medicines, for more species, in more countries in Europe, making the veterinarian’s job of ensuring the health of Europe’s animals just that little bit easier.