The Commission's proposal revisiting its legislation on veterinary medicinal products is an important step towards completing the single market in pharmaceutical products in this field.
It proposes the extension of the centralised authorisation procedure and the setting up of a central database listing all veterinary medicinal products authorised in the EU.
It also calls for the harmonisation of the summary of product characteristics (SPC) or the classification of medicines. These are among a number of long-awaited measures featured in the proposal.
There is logic behind a central authorisation procedure, in terms of efficiency and availability of medicines in the member states. However, there has been an ongoing debate on the need to maintain other authorisation channels for these products.
Some companies lack the necessary resources for a centralised marketing authorisation procedure, while others supply products that are destined for very limited geographical markets.
Therefore, other authorisation channels are often a more suitable alternative for these businesses.
As shadow rapporteur on behalf of Parliament’s Progressive Alliance of Socialists and Democrats group, I welcome the Commission's proposal and the good work that has been done by rapporteur Françoise Grossetête to date.
I am pleased to see that the draft report tackles head on the major obstacles faced by the marketing of these products today.
The European Parliament is very concerned by the problems linked to the extensive overuse of antibiotics in farming practices, and the negative consequences these practices have on human health, such as antimicrobial resistance.
Our aim is to restrict the use of antibiotics for both prophylactic and metaphylactic purposes, establish a list of antibiotics reserved for human use only, reinforce the traceability of antibiotics in the EU, as well as grant the use of human medicines only as a last resort in the treatment of animals.
We want clear definitions and unambiguous marketing rules for antibiotics in the member states. There should no grey areas in the legislation that could allow for misinterpretation or abuse.
One area where the Commission's proposal is weak is its failure to adequately address the issue of environmental protection.
We don't need to reassess a wide range of existing products, but rather to consolidate existing data on the environmental fate and effects of active pharmaceutical substances that are known to represent a risk into a monograph system.
Data sharing is already applied in EU legislation, and could be adapted to veterinary medicinal products. This would be a positive step forward in safeguarding public health and environmental protection.
This has been the subject of lengthy discussions, and it seems that the most likely option would be to ask the Commission to conduct a feasibility study, taking into account the specific nature of the veterinary market.
This study would shed light on the best approach to take. I would also support the rapporteur in harmonising the summary of product characteristics based on the conditions of use. In this regard, I am proposing to give the marketing authorisation holder the option of harmonising the same product in different member states, so as to have a totally harmonised SPC - including key quality elements.
This would be to the advantage of the marketing authorisation holder, and also beneficial for the long-term maintenance of harmonised authorisations.
Our priority in the committee is to find the best way to incentivise the development of new antibiotics for veterinary use, as well as to increase the safety and the availability of veterinary medicines across EU member states.