Priority areas for IFAH-Europe in a scope of the Project of Regulation of EP and Council about VMPs.

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Priority areas for IFAH-Europe*

 

1. Protection of technical documentation
 

Articles 34 - 35: The decline in innovation and investment in the VMP sector is of serious concern.  The Commission’s proposals will not be sufficient to rectify the situation, particularly for new antibiotics and for additional major species. We believe this would create incentives for a thriving market both for originators and generics.

 

We ask the Council to:

  • support the small improvements proposed by the Parliament, but advocate a maximum overall data protection period of 18 years for major species, as proposed by the Commission.
  • include further improvements to allow 5 years (stand-alone period) for significant investments to ALL types of existing products (not limited to antibiotics 18 years for new antibiotics)

 

2. Summary of Product Characteristics (SmPC) harmonisation process
 

Articles 68 -71: IFAH-Europe supports this objective, provided that a realistic and workable procedure is established. The Commission proposal requires significant amendments. The Parliament will propose a text that goes in the right direction to accommodate two scenarios. We believe this would enable a marked increase of availability of veterinary medicines across all EU Member States.

 

We ask the Council to support:

  • a voluntary harmonisation procedure for ‘same’ products - from one marketing authorisation holder (MAH) - with different national SmPCs, at least resulting in an ‘MRP product’ so that the harmonisation is retained, but preferably resulting in an EU marketing authorisation.  This should include the possibility to harmonise the essential elements of Part II of the dossier, resulting in the same manufacturing specifications for the same product throughout Europe.
  • the need for another harmonisation procedure for essentially similar products (and not groups of similar products, which is too wide) where there are unacceptable divergences in the conditions of use.  This can be achieved using the referral procedure.  In order to avoid high administrative burden for authorities and marketing authorisation holders, the scope of the harmonisation should be restricted to products with potential risk.

 

3. Re-arrangement of the packaging and labelling
 

Articles 9-15: With a view to achieving a wider availability of products in smaller markets, we believe that the new Regulation should facilitate the preparation and use of multi-lingual labels.

This is why we ask Council to consider:

  • minimising the text on the immediate label (restrict text to just that necessary for the unique identification of the product (i.e. no text on instructions for use, such as route of administration or withdrawal period need be on the immediate label). 
  • placing all other text, including instructions for use, such as route of administration and withdrawal period, in the pack leaflet or outer carton where necessary.
  • Using standard pictograms and abbreviations to replace text, and allowing the adding of information that complies with the SmPC, if sufficient space is available

 

4. Reduced administrative burden
 

Article 143: simplified registration procedures and simple majority voting at CMDv;

Articles 72-81: risk-based pharmacovigilance system under-pinned by an EU pharmacovigilance database and signal management system

Articles 58-67risk-based variations system with minor variations being notified to the product database

Article 5.2: the deletion of renewals and the sunset clause.

The high administrative burden in the VMP sector is of particular concern to IFAH-Europe.
 

We ask the Council to support the Commission proposal for all of the above.

 

5. Antibiotics
 

Antibiotics is a sensitive issue, and our plea is to keep all decisions and lists science-based, for example by reference to guidance from EMA/CVMP.  IFAH-Europe supports ESVAC and responsible use programmes. 

Outright bans on substances or products is a crude instrument as it bypasses the scientific assessment of need and risk through the marketing authorisation benefit/risk assessment process.
 

We ask the Council to support a science-based and risk-based approach with a clear role for the EMA/CVMP.

 

6. Decisions refusing a marketing authorisation

Article 32

 

  • Environmental safety

 

Proposing several new reasons why a marketing authorisation can be refused would undermine the marketing authorisation process and alter the long-established broad definition of veterinary medicinal product.  These products should continue to be allowed subject to the normal benefit/risk assessment process.

 

A substance should not be refused on the basis of a hazard assessment; the Marketing Authorisation process relies on the risk assessment of a product, which will include possible risk mitigation measures. Emphasis needs to be placed on the risk assessment of a product (not substance a.o. substances of high concern and high PBT - persistency, bioaccumulation, toxicity).

 

To rule out products that do not compare favourably with a “reference product” might prove difficult; indeed a reference product does not exist for most diseases; a choice of a range of products is important in many situations to suit different conditions and, for antimicrobials, to minimise pressure on the development of antibiotic resistance.
 

We ask the Council not to include such additional grounds for refusal to the list of Art. 32.

 

  • Genetically Modified Organisms

 

Banning the use of genetically modified organisms would have far-reaching implications on the ability to control some important animal diseases, as it would prevent medicines manufacturers from placing on the market products that rely on biotechnology. These are primarily vaccines and are essential tools for the prevention of animal diseases and maintaining herd health. Furthermore, the availability of these vaccines have the potential to significantly reduce the need for antibiotics. It is worth noting that one of the most commonly known animal diseases, rabies, has been virtually eliminated from Europe through the use of a vaccine containing this technology.

 

We ask that the Council to support innovation.

 

  • Zootechnical products (Articles 32.1 c +32.1 h)
     

Some zootechnical products bring benefits other than therapeutic benefits. Veterinary Medicinal Products can also bring benefits to animal welfare and/or have a positive effect on the environmental sustainability of livestock farming, and/or potentially provide alternatives to antimicrobial use by preventing disease through metabolic modification.

For this reason these zootechnical products should not be prevented from entering the market.
 

We ask the Council to adapt the Commission proposal accordingly.

 

*prepared based on Information received from IFAH-Europe

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