Rapporti verbatim tad-dibattiti

L-Erbgħa, 1 ta' April 2009 - Brussell

20. Iffissar ta' limiti ta' residwu ta' sustanzi farmakoloġikament attivi fl-oġġetti ta' l-ikel li joriġinaw mill-annimali (dibattitu)

  Le Président. - L'ordre du jour appelle la recommandation pour la deuxième lecture de la commission de l'environnement, de la santé publique et de la sécurité alimentaire relative à la position commune du Conseil en vue de l'adoption du règlement du Parlement européen et du Conseil établissant des procédures communautaires pour la fixation des limites de résidus des substances pharmacologiquement actives dans les aliments d'origine animale, abrogeant le règlement (CEE) n° 2377/90 du Conseil et modifiant la directive 2001/82/CE du Parlement européen et du Conseil et le règlement (CE) n° 726/2004 du Parlement européen et du Conseil (15079/2/2008 - C6-0005/0009 - 2007/0064(COD)) (Rapporteur: Avril Doyle) (A6-0048/2009).

  Avril Doyle, rapporteur. − Mr President, could I start by thanking all my shadow rapporteurs, and indeed the French Presidency for facilitating an early second-reading agreement?

This is a rather technical proposal as it aims to update the existing EU regime, the main purpose of which is to protect public health by limiting the exposure of consumers of food of animal origin to residues of pharmacologically active substances present in veterinary medicines and biocidal products. This is achieved by setting safety thresholds or maximum residue levels (MRLs) for approved substances and by banning substances which are either found to be unsafe or in respect of which a safety profile cannot be scientifically established.

MRLs alone do not protect consumers. Consumers are directly protected by setting an appropriate withdrawal period before slaughter and by having controls in place to monitor it. In practice the withdrawal periods are set using a high safety factor which will reflect the amount of data available at the current stage of product development.

We have reached an agreement on the key issues. First of all, extrapolation of MRLs set for one species to another; secondly, adopting within the EU MRLs set internationally within the Codex Alimentarius; and, thirdly, creating a framework setting MRLs for food imported from third countries.

We managed to clarify the measures which need to be taken when unauthorised substances are found either in EU-produced food or in food imported from third countries, as well as clarifying the basis for reviewing these reference points for action (RPAs): that is, the maximum level established for control purposes for any unauthorised substance in the light of any new data.

The question of setting MRLs for certain biocidal products such as disinfectants used in the animal environment was also agreed on, particularly in regard to the financing aspects of their authorisation and their dossiers.

The establishing of an MRL for a pharmacologically active substance requires an expensive data package of toxicology and metabolism studies. This is too costly for certain less common food species, so-called ‘minor species’, as the market for veterinary medicines for these is small – so-called ‘minor uses’. Setting an MRL is the first step that must be accomplished before an application can be submitted to the regulatory authorities for authorisation of a veterinary medicine for a food-producing species containing a pharmacologically active substance.

So this Minor Use/Minor Species (MUMS) issue is a problem urgently in need of resolution as it creates potential animal welfare and food safety issues. Vets have a duty of care and will always try to treat a sick animal. Under present legislation they are often forced to resort to unlicensed medicines.

The lack of an MRL also prevents authorities from being able to establish a proper withdrawal period for a medicine. The current MRL Regulation does not require MRLs to be set for individual species. The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) sets MRLs for individual species, following an initial cautious approach. In 1997 and following five years’ experience, the CVMP reviewed all the MRLs that had been set and concluded that it was not necessary to set MRLs for individual species as the MRLs for a particular substance are nearly always similar or identical. That same year, the CVMP issued a guideline on the establishment of MRLs for minor species. It defined minor food-producing species as all species except cattle, pigs and poultry, and they included salmonidae.

It allowed the extrapolation from a major species to a minor species of the same family, ruminant to ruminant, fish to fish, chicken to other poultry. In 2008, after eight years’ experience, the CVMP issued a new guideline. The Risk Analysis approach for residues of veterinary medicinal products in food of animal origin. This describes a risk-based approach of extrapolation of an MRL for a substance from one or more species to additional species. This guideline allows the extrapolation of MRLs from data on the three major species to all species, provided the MRLs set for the three major species are similar or identical.

The text of this review before us simply provides a legal basis for the current practice of extrapolation in the interests of veterinary medicines availability and animal welfare.

Two amendments specifically target the lack of availability of species-specific medicines for equidae (I must declare an interest) across a range of therapeutic and welfare needs, including the concept of ‘clinical benefit’ and not just the requirement that it is ‘essential’ to have a medicinal product added to the positive list of substance for equidae referred to in the Veterinary Medicines Directive. In clearly defined circumstances, certain products used for equidae will not have to have MRLs but will have to respect a six-month withdrawal period.

Perhaps there is a declaration – may I ask through the Chair – that the Commissioner is going to put on the record: I recall a discussion in relation to this issue some months ago concerning a review of the Veterinary Medicines Directive.

  Günter Verheugen, Vizepräsident der Kommission. − Herr Präsident, meine sehr verehrten Damen und Herren Abgeordnete! Die Revision der Gesetzgebung zu Höchstwerten für Rückstände pharmakologisch wirksamer Substanzen in Lebensmitteln tierischen Ursprungs ist eine wichtige Initiative für die Europäische Kommission. Sie zielt darauf ab, den Verbraucher vor Medikamentenrückständen in Lebensmitteln zu schützen und gleichzeitig die Verfügbarkeit von Tierarzneimitteln in der Gemeinschaft zu verbessern. Es ist aber auch ein wichtiges Element im Rechtsvereinfachungsprogramm der Kommission.

Rat und Parlament haben am 21. Oktober des vergangenen Jahres eine Übereinkunft getroffen, die in dem vorliegenden Gemeinsamen Standpunkt ihren Niederschlag gefunden hat. Wir haben jetzt also eine gemeinsame Position sowohl des Rates, des Parlaments als auch der Kommission. Ich bin sehr froh darüber, dass die Kommission die Änderungsvorschläge sowohl aus dem Europäischen Parlament als auch des Rates übernehmen konnte, weil sie Geist und Substanz des ursprünglichen Vorschlags der Kommission bewahren.

Die Kommission hat deshalb mit ihrer Mitteilung an das Europäische Parlament vom 8. Januar dieses Jahres ihre volle Unterstützung für den Gemeinsamen Standpunkt zum Ausdruck gebracht. Mit der Annahme des Gemeinsamen Standpunktes wird es nunmehr möglich sein, dieses Dossier zu einem guten Ende zu bringen, noch bevor die Legislaturperiode des Parlaments endet.

Der Abschluss auf der Grundlage des vorliegenden Gemeinsamen Standpunkts wird es denjenigen, die täglich mit Lebensmittelkontrollen und Tierarzneimitteln zu tun haben, ermöglichen, eine bessere Arbeit im Interesse der Tiergesundheit und des Verbraucherschutzes in der Gemeinschaft zu leisten. Diejenigen, die täglich damit zu tun haben, warten schon sehr lange und sehr ungeduldig auf die Überarbeitung der Gesetzgebung zu den Höchstrückständen, und ich finde, sie haben jetzt wirklich lange genug gewartet und können alle gemeinsam zufrieden sein, dass wir jetzt eine Lösung gefunden haben.

Ich bin mir der besonderen Bedeutung der Verfügbarkeit von Tierarzneimitteln sehr bewusst. Deswegen wird die Kommission, ungeachtet des Fortschritts, den die vorliegende Verordnung zu Höchstwerten von Rückständen pharmakologisch wirksamer Substanzen in dieser Hinsicht bereits darstellt, im Jahr 2010 eine Bewertung der Probleme bei der Anwendung der Tierarzneimittelrichtlinie vorstellen und dort, wo es angemessen ist, entsprechende neue gesetzgeberische Vorschläge vorlegen.

Mein ganz besonderer Dank gilt an dieser Stelle der Berichterstatterin Frau Doyle und ihrem wirklich unermüdlichen Einsatz, der es ermöglicht hat, eine Einigung in dieser bedeutsamen Angelegenheit zu finden. Noch einmal herzlichen Dank für Ihre großartige Arbeit, Frau Doyle!

Doyle report

The Commission is aware of concerns expressed by citizens, veterinarians, Member States and the animal health industry as regards the directive laying down the rules for the authorization of veterinary medicinal products, in particular the importance of addressing existing problems linked to the availability of veterinary medicines and the use of medicinal products in species for which they are not authorized and any disproportionate regulatory burden hampering innovation, whilst ensuring a high level of consumer safety with respect to food of animal origin. The Commission points out that positive steps are being taken in this direction such as the simplification of the rules on variations of veterinary medicinal products and this review of the legislation on maximum residue limits in food.

In addition, in order to address the objectives of consumer safety and animal health protection, competitiveness of the veterinary industry including SMEs and reduction of administrative burden, the Commission will present in 2010 an assessment of the problems in the application of the veterinary medicinal products directive with a view to making, where appropriate, legal proposals.

  Avril Doyle, rapporteur. − Mr President, I would like just to put on the record that there is one amendment which I cannot support as it would, in fact, create a legal impasse. If you cannot administer a drug under test to animals unless it already has an MRL, then you cannot carry out tests that are necessary to obtain the data to establish MRLs and the withdrawal period in the first place.

I would like to thank the Commissioner for his cooperation in this area and put on the record the urgent need for review of the Veterinary Medicines Directive. In a sense we are using this MRL review as a bit of a ‘patch and mend’ for a major problem that is under the radar but which we are all very aware of. The availability of an adequate range of veterinary medicines to treat the wide variety of animal species in the European Community has been a growing challenge over the last two decades. During this period, considerable efforts have been made by various stakeholders, including regulators, industry and veterinarians, to address the problems of the availability of medicines.

Despite these efforts, the situation has continued to deteriorate. The lack of authorised medicines poses a real threat to animal health and welfare and the safety of consumers. It also raises significant problems for animal owners, farmers, veterinarians and governments if animals are untreated, or treated with an unauthorised or an unsuitable product – including the risk of zoonotic disease implications from untreated or inappropriately treated animals for the animal owners, consumers and citizens.

There are also financial, legal and trade implications for the various stakeholders involved, whilst the lack of medicines may have negative effects on rural economies and agriculture generally. An example – and a most important point – is the effect on pollination as a consequence of reduced numbers of bee colonies. Bees are a very important Minor Use/Minor Species (MUMS) issue.

However, not only does the current availability problem in the EU have implications across the board 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 to attract research and development in the veterinary pharmaceutical field.

Thank you again to all colleagues and the Commissioner for cooperation on this report.

  Le Président. - Le débat est clos.

Le vote aura lieu demain.

Déclarations écrites (article 142)

  Péter Olajos (PPE-DE), írásban. – Sokszor elhangzó panasz, hogy az EU mindent szabályozni akar, és közben fontos kérdésekkel nem foglalkozik.

Sokan gondolhatnák, hogy ez a jelentés is ilyen. Ez azonban tévedés. Itt ugyanis emberek által fogyasztott "élelmiszerről" van szó - ezt szeretnénk biztonságosabbá tenni a polgárok érdekében.

Az eddigi szabályozás elavult valamint megnehezíti az állatorvosok gyógyszerkészleteinek feltöltését. Ezért van szükség az ágazat jelenlegi sajátosságainak megfelelő szabályozásra.

Manapság egyre több gyógyszercégnek van állat-készítményekkel foglalkozó részlege, jelentős bevételt produkálva. És az igény folyamatosan nő, hisz az állatok is megbetegszenek, és ma, amikor az élelmiszer egyre többet ér, ezt megéri elkerülni.

Azonban az utóbbi időben több olyan információ is eljutott hozzánk, miszerint egyes cégek azon dolgoznak, hogy hogyan lehetne minél többet "kinyerni" az állatokból. Gyorsan növő csirkék, néhány hónap alatt óriásra hízó disznók. Teszik mindezt olyan (gyógy)szerekkel, amelyek sokszor károsak az emberre nézve.

Ezért kell minden egyes állatokba bejuttatott készítményt bevizsgáltatni, az EMEA közreműködésével, hogy ezek a szerek az állatban maradva és majdan emberi fogyasztásra kerülve jelentenek-e bármilyen veszélyt

A vizsgálatot a cég fizeti. Ki kell még emelni a gyorsított eljárás lehetőségét, mely csökkenti az adminisztráció idejét, valamint fontos, hogy az állatorvosok így sokkal könnyebben juthatnak gyógyszerekhez.

Az emberek egészségénél nincs fontosabb -ezért gátat kell szabni a pénz-vezérelt "állat-doppingnak".