PM+: Red tape blocking EU animal health sector innovation
The veterinary medicines sector is unfairly expected to follow the same procedures as the human sector, argues IFAH-Europe's Roxane Feller.
Animals, just like people get sick and require medicines. Veterinary medicines, just like human medicines, must be authorised before they are placed on the market.
Although the veterinary medicines market is a small fraction - around three per cent - of the size of the human medicines market, it is subject to just as stringent a regulatory process when it comes to developing and producing medicines for animals.
There are also additional consumer safety studies needed for medicines that are developed for food-producing animals.
In fact one could argue that the veterinary sector goes through an even more stringent process as the costs for the procedures involved in making animal medicines available amount to around 13 per cent of the sector’s annual turnover; double the costs required for the human health sector.
- EU's animal health sector 'essential' in fighting disease
- Monitoring and transparency key to tackling animal antibiotic resistance
- Pressing need for 'system change' in antibiotic use
But why do animal health products go through the same procedures as human medicines when the sectors are so different? Let’s take a look at some of those differences.
The human sector deals with only one species, human beings. The veterinary sector handles a multitude of different species requiring not only different medicines for different diseases but different ways of delivering them.
The need to develop medicines for a wide range of species, sometimes with completely reformulated products and alternate routes of dispensation, make the administrative burden of getting these medicines approved seem endless.
Development requirements for the two sectors are also currently very similar even though the approach to assessing the benefit-risk of a human medicine is very different from that of a medicine say for example, for a broiler chicken. So these authorisation requirements can have a significant impact on the cost of medicines for animals.
And who pays for the cost in the end? Unlike human medicines where national health services in many countries subsidise the cost of medicines, it is the animal owners who have to pay the full costs of treating sick farm animals or pets.
A quick glance at Europe’s agri-food business with its estimated two billion birds and 300 million other animals used for farming purposes across the EU provides a rough idea of the enormous expense involved.
There is also an extra administrative layer for the veterinary sector with food safety tests needed for food-producing animals. Considered of great importance to the industry and abided to rigorously, medicines for food-producing animals require extra R&D investment to verify both consumer safety, ensuring our food is safe to eat, and environmental safety.
This administrative burden has led to a reduced rate of innovation, - 20 per cent according to our 2011 global benchmarking survey - and lower product availability, particularly for minor species and smaller countries.
Here at IFAH-Europe we believe it's time Europe’s policy-makers truly took a look at the major differences between the veterinary and human medicines sector in terms of who the products are made for and how they are provided and used.
To ensure investment in product development that is proportionate to the veterinary medicines’ value and not just an additional unnecessary administrative burden EU rules and regulations need to take into account the unique characteristics of the veterinary sector.
This content is published by the Parliament Magazine on behalf of our partners.
There is a weak correlation between animal consumption of antibiotics and human resistance, argues Rick Clayton.
EU policymakers need to chip in and do their part in tackling the illegal wildlife trade, argues Sonja Van Tichelen.
No one likes to talk about salmonella in feed, but the consequences of the recent formaldehyde denial mean we will be forced to talk about it a whole lot more, warns Phil McGuire.