Speech of Avril Doyle, MEP, at the public hearing on the EU Animal Health Strategy and Vaccine Technologies
Hearing on Animal Welfare and Vaccine Technology
Brussels, 13th February 2008
Hosted and Chaired by Avril Doyle MEP
The Community Animal Health Strategy's motto is "prevention is better than cure": this reflects two major issues: 1) where the EU had to slaughter millions of animals to fight the outbreaks of Foot-and-Mouth-Disease and Swine-Fever and 2) it reflects the increased emergence and re-emergence of other threats to our animal health and welfare.
The Community's animal health has improved considerably in recent years and the present strategy aims to further improve the legal framework, surveillance and crisis preparedness. However, a very significant element concerns the support for Science and with the Community Animal Health Strategy, the EU has recognized R&D as an important element to fight infectious animal diseases and thereby adhered to the principle of prevention over cure.
There remains today many unmet therapeutic needs for veterinary medicinal products in the EU. Total sales of veterinary medicinal products in the world are only 3% of that of human medicines; ‘a paradigm shift is required to advance animal health.[1] The current regulatory framework (for veterinary medicines) is the biggest obstacle to innovation, together with a decline in the social acceptance of risk in Europe towards the animal health industry.[2] We do not want to wait until an emerging disease reaches crisis state, at which point regulations might be ‘relaxed' but no innovative products will be in the pipeline.[3] According to the Task Force on Medicines Availability (2007 report) political decisions to fund the needs of animals for medicines are needed ahead of the next planned revision the overall veterinary medicines legalisation. To wait 5-10 years to review certain aspects of the legislation would be negligent.
Furthermore, the current legal framework for (Maximum Residue Limits in foodstuffs of animal origin) MRLs has lead to particular problems for animal welfare. The Commission adopted a draft proposal in April 2007 to review MRLs and I am the European Parliament Rapporteur on this proposal. There are three main problems in this area:
1) The Availability of veterinary medicines has decreased to an extent that creates adverse effects for public and animal health and animal welfare.
There are an insufficient number of medicinal products available for the therapeutic treatment and welfare of animals. This is particularly alarming for certain minor use and minor species such as sheep and horses, bees and fish. As a result of this, there is a major deficiency of authorised medicines and the "off-label" use of products is increasing, which jeopardises effective residue control with serious implications for consumer safety. There is also serious concern within the veterinary profession at the increasing therapeutic void resulting from the loss of essential substances with the added risks for animal health and welfare, which may also compromise the safe supply of animal protein for the human food chain.
Extrapolation
The Commission proposes to make the assessment of possibilities for extrapolation a compulsory part of the overall scientific assessment and create a legal basis for the Commission to lay down the principles for applying extrapolation. This will encourage the development of drugs to cover minor food-producing animals and thereby diminish the risk to public health from "off-label" use of drugs. It will also reduce the development costs of new drugs without changing the existing high safety margins for public health.
2) CODEX Alimentarius
After going through the process of having a CODEX MRL set (where the EU has a vote and is fully involved in the Scientific Committees), companies have to repeat the effort again for the EU market. The Commission proposes adapting Community legislation to include MRLs set at Codex Alimentarius with the support of the EU, thus reducing additional and unnecessary assessments.
3) Reference Points for Action
Control services of Member States have no points of reference in particular for substances detected in food from third countries.
In this regard the Commission proposes creating a specific legal framework to set MRLs for pharmacologically active substances not intended to be authorised as veterinary medicines especially for control purposes and for imported food. The Commission proposal ensures Minimum Required Performance limits (MRPLs),[4] (control tools based on expert advice that are used as reference points for action at border inspection) are based on a sounder legal footing thus improving consumer protection and the functioning of the Single Market.
Returning to the subject of R&D, I want to call for the Commission and the Council to continue to increase their commitment to support R&D for improved animal health - not just in Europe, but globally. This support is needed because the health of animals is a public concern and offers only small return to private investors: the EU has therefore a crucial role to play.
Infectious animal diseases such as avian influenza, blue tongue and foot-and-mouth disease are global problems and they cannot be tackled in Europe alone. Unbridled climate change, coupled with the increase in global trade and indeed travel, will have a significant impact on the spread of disease and disruptions to the food chain. The appearance or development of certain exotic animal diseases in Europe can be directly linked to effects of climate change. Vectoral diseases are the most visibly influenced by global warming. The rise in global temperatures creates the conditions for viruses and the vectors that transport them to migrate north.
Given these factors, animal health must be part of the relationship with our international partners from the US, China, Russia - but also Africa, from where most Zoonoses emanate, in order to fight infectious diseases effectively and improve the quality of life for our fellow man where ever they may be. We need to work with the researchers at the places where the diseases occur to address these challenges.
Furthermore, it needs to be recognised that the consequences and cost of a major outbreak of a high-impact disease in the EU far exceeds the cost of development of an appropriate medicine. Not only does the current availability problem in the EU have implications for the health and welfare of animals, the security of the Community's food supply and public health, it also undermines the ability of the EU to meet the Lisbon agenda and to reap the enormous potential for European agriculture and offshore aquaculture.
We cannot allow inventions from other regions not to be used in the global fight against infectious diseases. We therefore must find easier ways to transfer innovations. We need global R&D collaboration to do so and to develop world class innovation. We will see an example of such an innovation later today, a vaccine targeting Newcastle Disease expressed in plant-cells for which Dow AgroSciences received global regulatory approval in the US.
With respect to R&D in Europe, FP7 is probably the most visible programme, however in budget terms FP7 only represents about 5 percent of the European R&D landscape. The member states devote far more money to R&D than the Commission ever could. I would therefore like to encourage a better and improved dialogue between the EU Member States and other regions to combine their efforts to develop effective R&D tools to control the threats against animal and human health. Infectious diseases do not stop at borders and there is no reason why national R&D expenditure to fight infectious diseases should do so.
[1] Presentation by Mr. George Gunn, President IFAH International, DIA Global Animal Health Conference, EMEA, London, 15-16 Nov, 2007.
[2] Presentation by Mr. Richard Meads, Business Decisions Limited, DIA Global Animal Health Conference, EMEA, London, 15-16 Nov, 2007.
[3] Presentation by Dr. Jim Riviere, North Carolina State University, USA, DIA Global Animal Health Conference, EMEA, London, 15-16 Nov, 2007.
[4] MRPLs were first introduced in Commission Decision 2005/34/EC laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries.
