The manufacture, quality control, registration, distribution and packaging of veterinary medicines are controlled by a plethora of European Regulations and Directives. These are separate from those pertaining to human medicinal products but no less demanding.
The manufacture, quality control, registration, distribution and packaging of veterinary medicines are controlled by a plethora of European Regulations and Directives. These are separate from those pertaining to human medicinal products but no less demanding. The original Directives 81/851 and 81/852 reflected in many ways the existing UK controls required under the Medicines Act 1968 with the authorisation of products being based on the principles of Safety, Quality and Efficacy. Since then there have been many changes and new legislation to try to introduce better ways of producing a single market and a single process for bringing human and veterinary medicines to the European market.
In practice the establishment of various bodies such as the European Medicines Agency (EMA) at Canary Wharf in London and a centralised procedure for new/novel and GMO products, giving an EU wide approval, together with the ability to extend national licences by mutual recognition procedures in other Member States, has not lead to many benefits for veterinary medicines, and has substantially increased the complexity and costs of registering them. In particular Mutual Recognition which was supposed to limit the concerned Member States in which application was made to raising questions only on serious safety issues, developed into an attritional process in which the original Authorisation was emasculated by imposition of countless national requirements. The failure of Mutual Recognition led to introduction of a decentralised procedure in 2004, but this has suffered from the many of the same issues and problems.
The Commission has finally recognised that the cost of bringing new veterinary medicine products to the market, especially for farm animal species is so high, and the risk of failure in the process so great, that the result has been to virtually eliminate the registration of new pharmaceutical active ingredients. An area of particular concern is the development of resistance to many of the existing worming products essential for global production, where there is likely to be a profound effect on the welfare of farm animal populations if novel products are not introduced. The Commission is instigating a detailed review of the whole process of authorising veterinary medicines. Currently the cost incurred in registering a new active is very unlikely to allow sufficient profit to be made from subsequent sales to make the investment realistic. One of the main reasons for this is that the time from discovery to market is now typically around 13 years allowing only 7 years of patented protection. Generic manufacturers can then make use of the pioneer products intellectual property to authorise their own versions, at greatly reduced cost.
Two areas of data requirements that are causing much concern for those involved in the development and production of food animal medicines are the complex rules protecting consumers from residues of medicines in human food derived from animals and those relating to possible effects of excreted medicines and their metabolites on the environment.
The EMEA has sought to mitigate this by introducing a minor use, minor species (MUMS) policy. This reduces some fees and data requirements, allows for the opportunity for free scientific advice on required studies and coupled with other financial help for small and medium enterprises was hoped to alleviate the situation. But to date it has not proven very effective. As the term minor uses, minor species suggests, it is unlikely to be in the forefront of large commercial organisations investment priorities.
All farm animal products, including new generic applications require a full Environmental Risk Assessment. The data package is expensive and open ended depending on the results obtained. In general it is modelled on that required for crop pesticides where chemicals are applied to exert a biological effect. This is not the case for the excretion products of medicines. The recent EMEA Guidelines are very proscriptive and require data compliant with current OECD Guidelines. This is being applied in a manner that is detrimental both for the continued existence of well established products and a barrier to the introduction of novel ones.
ADAS can help reduce the cost of Environmental Risk Assessment. Our specialist Cambridge Environmental Assessments (CEA) group are experts in applying our knowledge of real world agriculture to specialist modelling techniques that satisfy our clients' needs for cost effective alternatives to additional testing. For further information please contact Paul Mason on 01954 268286 or e-mail Paul.Mason@adas.co.uk.
What of the future? Currently there is a review of the regulation of veterinary medicines taking place. However this is an area where there are many political and single issue pressure group “sacred cows” at stake and finding a simplified, effective consensus is likely to prove difficult.
Recent attempts at simplification of procedures such as that for varying Authorisations have not made the process any simpler although they have introduced ways of making multiple changes possible with one application. It is the Authors experience and opinion after 30 years working in the field that all regulatory changes lead to more complication and expense. The majority of R & D expenditure by animal health pharmaceutical companies is directed at product defence rather than innovation. The recent changes in the structure of the Commission which puts political control of veterinary medicines firmly in the province of consumer protection is unlikely to improve matters.
The Veterinary Medicines Directorate which is responsible for controlling animal medicines in the UK works hard to explain and ease the regulatory burden to its customers but is constrained to work within the framework of EU legislation.
In an increasingly global world market with demand for animal food products rising along with the world population the adoption of an over precautionary regulatory approach will undoubtedly lead to shortages and price rises.
Photograph by kind permission BAH.