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Revising the rules on medicines

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THE phrase ‘the devil is in the detail’ is overused and should probably have been put out to grass some time ago. However, it could have been invented to describe proposals for reforming EU legislation on veterinary medicines and medicated feed, which were adopted by the European Commission last week. The Commission's proposals have been a long time coming and will doubtless be subject to discussion and amendment in the months ahead. However, once the new rules are finally agreed and brought into effect they will have far-reaching consequences for industry, regulators and veterinary practice, affecting both the supply of veterinary medicines and the way they are used.

It would be hard to disagree with the aims of the proposals, which are to make more medicines available to treat and prevent diseases in animals, tackle antimicrobial resistance and foster innovation. As always, however, much will depend on how the rules end up being applied. With new legislation, things don't always turn out as planned, particularly in areas as complicated as this. At this stage, the important thing is to try to anticipate any unintended consequences and do everything possible to ensure that the aims are met.

Regarding making more products available, the Commission acknowledges that ‘the needs of the veterinary sector differ substantially from those of the human sector in relation to medicines’, that the drivers for investment are different and that innovation is being hampered by ‘red tape’. To address this, it aims to streamline the marketing authorisation procedures that allow companies to place and maintain new products on the market, while continuing to ensure that public health, animal health, food safety and the environment are protected. Companies wanting to gain marketing authorisations for new products will be able to make use of centralised, national, mutual recognition or decentralised licensing procedures and, having done so, will potentially be able to maintain data protection for their products for longer than is currently the case. Product labelling requirements will be simplified, to assist in marketing products throughout the EU; similarly, new rules on internet trading will be introduced with a view to facilitating internet trade across the EU, while ensuring that such trade is regulated.

Currently, marketing authorisations have to be reviewed every five years. Under the proposed new rules, authorised products will have unlimited validity, but there will be an increased emphasis on post-marketing authorisation measures and pharmacovigilance, including the establishment of a single pharmacovigilance database for all products licensed in the EU.

The proposed rules include specific measures aimed at making more products available for ‘minor species’, such as bees, fish and turkeys. They also aim to introduce more flexibility into the prescribing cascade that applies when licensed products are not available for a particular species or condition, by abolishing the current ranking system.

While many of the measures are aimed at improving the availability of veterinary medicines, others will have the opposite effect. In the words of the Commission, the proposed legislation ‘pays particular attention to combating antimicrobial resistance in animals and humans’ and will make it possible to restrict the use of certain antimicrobials in animals that are reserved for the treatment of human infections. Which antimicrobials those might be is not specified and, from an animal health perspective, this could be a matter of concern for the future.

Regarding medicated feed, the aim is to harmonise production standards and marketing of medicated feed at an appropriate level of quality and safety. Antimicrobial resistance will be tackled by measures that will include a ban on using medicated feed preventively or for growth promotion, as well as tighter rules on prescribing and handling medicated feed containing antimicrobials. The proposals also include specific provision for medicated feed for pets, raising the possibility that, in the future, pets with chronic conditions might be treated with medicated pet food.

Having been adopted by the Commission, the proposals will be considered by the European Parliament and then the European Council, and could come into force in 2016-2017. They are likely to be of most immediate interest to manufacturers and regulators but, given the importance of medicines to veterinary activity, they will ultimately have a significant impact on day-to-day practice. It will be important to consider the details carefully in the weeks and months ahead.

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