New EU regulation on veterinary medicines: more incentives for innovation
BVL Symposium participants discuss implementation – Increased fight against antibiotic resistance
With the new EU Veterinary Medicines Regulation, there is some hope: the availability of veterinary medicines in EU countries should be increased, the impetus for innovation increased and the fight against antimicrobial resistance. At the same time, the challenges are enormous. Until the implementation of the regulation, which came into force this year, there are only a good two years left, by the end date, January 28, 2022. What are the obstacles so far? What criticisms and expectations of the authorities and the pharmaceutical industry and the veterinary profession are associated with the regulation? These issues were the subject of a two-day symposium organized by the Federal Office for Consumer Protection and Food Safety (BVL) on November 5-6, 2019 in Berlin.
Among other things, the new Veterinary Medicines Ordinance provides that particularly critical antibiotics should be reserved for human medicine in the future. Parliamentary Secretary of State at the Federal Ministry of Food and Agriculture (BMEL), Hans-Joachim Fuchtel, sees this as a milestone in the fight against antibiotic resistance, as he made clear in his greeting to 180 guests. "At the same time, however, consistent development of new antibiotics is needed," said Dr. Lars Nickel from the Federal Ministry of Health (BMG). He hopes to see further progress in this area in the future.
The road to new EU regulation is still a long way off "and probably represents the biggest challenge for BVL in the coming years," its president said. Helmut Tschiersky. At EU level alone, 27 pieces of legislation were to be designed and implemented, the head of the unit, Christian Siebert of the European Commission's Directorate-General for Health and Food Safety, outlined the scope of the tasks. At least in the first phase, he sees implementation, but well on schedule.
Dr. Ivo Claasen of the European Medicines Agency (EMA) predicted that the administrative burden of the new Veterinary Medicinal Products Regulation would be reduced, which would also increase the incentive for more innovation and new product development.
The possibility is very narrow for the development and programming of three databases: at the center is a product database that must be linked to a pharmacovigilance database and a database for the production, import and distribution of veterinary medicines. "IT systems are the key to success," said Head of the Veterinary Medicines Authorization Department at BVL, Prof. Thomas Heberer.
Status of work on reorganization of national veterinary law by Andrea Sanwidi of BMEL. Until now, veterinary medicines legislation has been nationally regulated by the German Medicines Act and related regulations. An inter-ministerial working group, under the joint leadership of BMEL and BMG, coordinates legislative activities to reorganize national veterinary medicines law. The aim is to bring national legislation into line with EU law in a timely manner.
The pharmaceutical industry welcomes the new European regulation in its goals, as it also increases the competitiveness of manufacturers, as Dr. Cornelia Ibrahim of the Federation of Pharmaceutical Industries (BPI) reported. However, many issues remain open in implementation, so there are still many legal provisions for an indefinite period.
Representatives of the veterinary profession have differently evaluated the new regulations. They requested that at least the antimicrobials currently approved in veterinary medicine be available in the future.
The BVL Symposium also focused on how the quality of active pharmaceutical ingredients can be protected in dialogue with third countries. Most drugs are manufactured today in China and India. It is estimated that about 80 percent of the antimicrobials used in Germany in veterinary medicine come from China. Norbert Möller of BVL. The lack of quality of the active ingredients is increasingly reflected in bottlenecks. In order to ensure sufficient pharmaceutical quality, the manufacturing process at the manufacturer must be fully monitored. Cooperation between BVL and various Chinese authorities, which has been ongoing at the sector level since 2017, should be intensified in the future.
This was also the goal of Professor Xiaohui Yu from the Chinese Ministry of Agriculture and Rural Affairs (MARA) during the symposium. In front of 180 experts, Yu explained Chinese standards for veterinary medicines and their monitoring.
http://www.bvl.bund.de/Symposium2019 Symposium information
Features of this press release:
Nutrition / Health / Care, Medicine, Animals / Land / Forestry
Scientific meetings, scientific education