Announced as putting in place an up-to-date, proportionate body of legislation tailored to the specificities of the animal health sector, the new EU rules on animal medicines promise to simplify licensing procedures and to review incentives to improve the development and availability of prevention and treatment options.
As trilogue negotiations progress, there are numerous ways in which the new rules can shape up to deliver on objectives to foster innovation for improving the health and wellbeing of animals, while protecting public health.
First and foremost, it is essential that the legislation remains both science-based and predictable if industry is to deliver a wide range of solutions that allow vets to both prevent and treat diseases. Today, vets across Europe are concerned by a lack of certain medicines and there are often huge differences in availability between countries.
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Take France for instance, with over 6000 products licenced, versus countries like Latvia or Lithuania with so much less. Treatment gaps exist for all kinds of animals, even for the more common species, like dairy cows, where vets are asking for solutions, such as a vaccine for prevalent ailments like lame cow disease.
More efficient rules for animal medicines with continued scientific-backing, can help stimulate innovation once again, and allow for new prevention and treatment options to be made available. This will not only increase Europe’s preparedness for future animal disease threats, but it will also ensure that vets across Europe are well-equipped to take on any animal health challenge.
The new rules could also prevent a blanket ban on substances: Abandoning a proper benefit-risk analysis of a final product is a sure way to set up a road block to innovation. For example, a decision made with regard to one element of a final product, without a detailed scientific benefit-risk analysis of the product as a whole, could lead to a serious reduction in the vet’s armoury.
A balance needs to be struck between animal health and welfare, public health and socio-economic considerations. It is of utmost importance to ensure that a broad-brush ban on certain substances, such as those used in products to treat parasite infections in both animals and fish, do not lead to the banning of important tools for managing animal health risks in farming.
In addition, with a fairly solid starting base in the Commission’s proposal, the European Parliament backed measures to stimulate research into new medicines, including extending protection periods for technical documentation for new medicines and adding new protection periods for significant investments in data generated to improve an existing product.
However, while data protection gets our tails wagging, the new rules still leave some gaps to truly meet with the current needs of vets depending on animal medicines for a menagerie of patients.
There is a major lost opportunity, for example, in not extending data protection periods for adding a new animal species or a new disease indication to an existing product. What this means is that there are fewer treatments available for additional animals or uses, creating an Orwellian “All animals are equal, but some animals are more equal than others” situation.
Moreover, it’s crucial to avoid undue delays. There really is no time to waste in applying the new rules once they come into force. These revisions need to be supported by direct application of the provisions in order to urgently reverse the trend of fewer new products being made available. A marked decline in investment, with R&D spend dropping by 20 per cent over the past 15 years, clearly indicates that these rule changes should not be needlessly delayed further from application.
And finally, the new rules also need to remove some of the existing barriers to innovation. With animal medicines taking 6-12 years to come to market and costing anything up to €150m, it’s safe to say that the EU’s regulatory process for approving animal medicines is like a bull: strong and steadfast, but not easy to get past.
The revision makes great steps in trying to knock down some of the hurdles that have caused an inordinate amount of administrative burden which causes delays. A few small extra steps can make sure that resources are focused where they are needed, to ensure better protection of animal and public health.
At present, if approved by the national route – which counts for approximately 70 per cent of products - a product from one company cannot be produced in the same way for all member states. Currently, a treatment produced for Belgium, for example, cannot be used in another country in some cases, due to minor differences in manufacturing requirements.
Greater harmonisation in the area of manufacturing specifications would mean less complex manufacturing logistics for the different member states, again ensuring better coverage of medicines available across Europe. Such harmonisations can reduce the need to invest resources in administrative tasks, freeing up resources that can be invested elsewhere, like innovation.