EN United in diversity EN A8-0046/313. Amendment

Transcription

1 A8-0046/ Merja Kyllönen, Stefan Eck, Miguel Viegas, João Ferreira, João Pimenta Lopes, Marina Albiol Guzmán, Kostas Chrysogonos, Tania González Peñas, Miguel Urbán Crespo, Lola Sánchez Caldentey, Xabier Benito Ziluaga, Estefanía Torres Martínez Recital 36 a (new) (36a) Nowadays, it is proven that heavy use of even the latest antibiotic can lead to development of an antimicrobial resistance within two years, leading to multiresistant infection, causing a major public health problem. Therefore, it is essential that the research is also directed to the development of new or improvement of existing methods to fight against infectious diseases that do not present the danger of resistance developing in bacteria, and that are safer for prophylactic use. For that reason research in methods such as bacteriophage therapy should be further studied and incentivised. Justification There are methods that could be used as an alternative to antibiotics, and bacteriophage therapy could be one of them. The cost of the development of such a method would be minor compared to the benefits that could bring to the patients, the healthcare systems and against the AMR. Several studies show the advantage of the prophylactic use of this kind of therapy.

2 A8-0046/ Merja Kyllönen, Stefan Eck, Anja Hazekamp, Marisa Matias, Miguel Viegas, João Ferreira, João Pimenta Lopes, Marina Albiol Guzmán, Lidia Senra Rodríguez, Kostas Chrysogonos, Stelios Kouloglou, Tania González Peñas, Miguel Urbán Crespo, Lola Sánchez Caldentey, Xabier Benito Ziluaga, Estefanía Torres Martínez Recital 52 a (new) (52a) In order to ensure that the imports from third countries of veterinary medicinal products, active substances, intermediate products and excipients used as starting materials have been manufactured in accordance with the animal welfare standards established in the Union, unlike for instance the current production method utilised in third countries for "pregnant mare serum gonadotropin" (PMSG), the Commission should revise Directive 91/412/EEC and include animal welfare standards in the good manufacturing practice for veterinary medicinal products.

3 A8-0046/ Merja Kyllönen, Miguel Viegas, João Ferreira, João Pimenta Lopes, Marina Albiol Guzmán, Lidia Senra Rodríguez, Kostas Chrysogonos, Tania González Peñas, Miguel Urbán Crespo, Lola Sánchez Caldentey, Xabier Benito Ziluaga, Estefanía Torres Martínez Article 8 paragraph 2 2. Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain unless: (a) the tested product is a veterinary medicinal product authorised for the food-producing species used in the clinical trial, and the withdrawal period set out in the summary of the product characteristics is respected, or (b) the tested product is an authorised veterinary medicinal product for target species other than the food-producing species used in the clinical trial and the withdrawal period set out in accordance with Article 117 is respected. 2. Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain.

4 A8-0046/ Merja Kyllönen, Stefan Eck, Miguel Viegas, João Ferreira, João Pimenta Lopes, Marina Albiol Guzmán, Kostas Chrysogonos, Stelios Kouloglou, Tania González Peñas, Miguel Urbán Crespo, Lola Sánchez Caldentey, Xabier Benito Ziluaga, Estefanía Torres Martínez Article 8 paragraph 4 a (new) 4a. With due regard to animal health and welfare, incentives should be given in the clinical trials to testing alternative methods for fighting and preventing infectious diseases, such as bacteriophage use, that prevent the development of antimicrobial resistance. Justification Bacteriophage therapy is a method that naturally fights against bacteria and doesn't develop antimicrobial resistance and could have the same advantage to the health of the animal. Further development and studies should be incentivised.

5 A8-0046/ Merja Kyllönen, Stefan Eck, Anja Hazekamp, Marisa Matias, Miguel Viegas, João Pimenta Lopes, Marina Albiol Guzmán, Lidia Senra Rodríguez, Kostas Chrysogonos, Stelios Kouloglou, Tania González Peñas, Miguel Urbán Crespo, Lola Sánchez Caldentey, Xabier Benito Ziluaga, Estefanía Torres Martínez, Cornelia Ernst Article 98 point c a (new) (ca) comply with the rules on good manufacturing practice for medicinal products established in the Union and use as starting materials only active substances which have been manufactured in accordance with the animal welfare standards established in the Union, as well as the rules on good manufacturing practice for starting materials established in the Union;

6 A8-0046/ Merja Kyllönen Article 34 paragraph 1 point b (b) 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application; (b) 10 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, salmon, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application; Justification The amendment aims to reduce the duration of protection of technical documentation of veterinary medicines to allow the access on the market of generics and thus improve the availability of medicines and the affordability (price control) of animal medication in the EU.