PHARMACEUTICAL – Animals also need keys to Europe’s medicine cabinet

ANIMALS across the EU are being increasingly denied the medicines they need. This goes further than an animal welfare issue. If left unchecked, this situation could also pose a serious public health risk.

The problem has been caused by the EU’s medicines approval system, which was intended to protect public health, animal health and the environment. This it does – but there is room for improvement.

The system has evolved piecemeal over 20 years and has had some serious consequences, including leaving many animals with an ever-shrinking medicine cabinet, even for the treatment of fairly straightforward diseases.

The problem is much worse for rarer conditions or less widespread species. The veterinary pharmaceutical legislation review seeks to address this, and it is these consequences that I hope will be borne in mind by my colleagues in Parliament when we debate the legislation in the autumn.

There are three areas where I believe further work needs to be done, and I will be supporting amendments to solve the current problems. The amendments aim to ensure that we have flexibility for local decision-making and will encourage investment in new products for our animals while, at the same time, protecting consumers.

Local needs, local decisions.

Harmonisation and an EU-wide single approval system is a desirable objective, but not if it means losing more medicines from the market.

In some cases, forcing a medicine to be approved by the centralised procedure (as the Commission has proposed), when it is only required in one market, may mean that it does not get registered at all, even in the market where it is needed.

Common sense dictates that a medicine for reindeer should be registered in Finland and a drug for salmon in Scotland. Failure to do this at national level will create competition between member states and mean fewer animal medicines on the market.

Big is not always best.

Currently, the EU’s regulatory framework encourages investment only in so-called ‘major species’ i.e. pigs, cattle and broiler chickens. Because, while a medicine for a less-widespread species costs the same in terms of time and money to license, the potential number of patients is much lower, meaning that often the sums simply don’t add up. There are currently proposals to increase investment in medicines for rarer diseases and in less-common species. Also, in the case of very specialised products, we often rely on the nichefocus of the EU’s small and medium-sized enterprises to do the R&D and bring them onto the market.

It is vital, therefore, that the regulatory framework encourages investment and increased medicine availability, no matter what the size of the animal, or the size of the company.

Public health will remain the top priority.

If medicines are to be used for farm animals whose produce enters the human food chain, food safety must be paramount. But today’s registration system already ensures consumer health protection. Increasing the red tape needed to obtain medicines for farm animals will not increase consumer protection.

Indeed, making it harder to obtain even simple remedies for farm animals could pose a threat to public health by increasing the chance of a ‘black market’ developing.

Furthermore, if medicines are bought ‘under the counter’, the end result will be uncontrolled use of medicines that have not been approved for use in that species, but may not have even been approved for animal use at all.

There are already EU-wide safety standards. However, each member state has established its own system of controls on farm animal medicine, tailored to its own traditions to ensure that these are met. Making the system of implementation ‘one size fits all’ will not improve consumer health and, indeed, may jeopardise it.

Animal medicines are registered to the same standards of quality, safety and efficacy as human medicines. And, in the case of medicines for food-producing animals, standards are even higher to ensure that our food is safe. But it is vital to strike a careful balance between regulating and making sure that our animals have access to medicines that they need to stay healthy.

Robert Sturdy is a farmer as well as being a Conservative member of the European Parliament.