Improved protection of technical documentation for new veterinary medicines

Background

  • The National Office of Animal Health (NOAH) represents the UK animal medicines industry: its aim is to promote the benefits of safe, effective, quality medicines for the health and welfare of all animals.
  • NOAH has 25 member companies, over 90% of the UK animal health market and sales worth £600M per annum.
  • The animal medicines sector is innovative and supports many highly skilled jobs across the UK.
  • NOAH is a member of the European trade association, IFAH-Europe (International Federation for Animal Health Europe).                               

Research and development:

  • Most R and D decisions for many NOAH members take place at an EU or even a global level
  • High levels of investment- Over £290 million sterling (€400 million)invested in EU p.a. +/- 12% turnover spent on R&D
  • 35% of R&D budget gets diverted into keeping existing products on the market

The review of the European Veterinary Medicines Directive

  • The legislation that governs veterinary medicines at a European level is currently under review.
  • The draft proposed legislation was published in September 2014. The proposed text is being considered now by the European Parliament and European Council who will put forward proposed amendments.

The objectives and the goal of the review of the Veterinary Medicines Directive:

  • Common goal – Improved availability of authorised veterinary medicinal products across EU MSs
  • Improve internal market for ALL veterinary medicines
  • Reduce admin burden with an efficient regulatory system
  • Stimulate innovation – improved protection of technical data
  • To address the public health risk of antimicrobial resistance

Top Priority for NOAH:

  • Stimulate and protect innovation – protection of technical documentation
  • After the period of time when a companies technical documentation is protected expires, other companies can obtain this data and manufacture and sell generics of the original product. Therefore, for the company who developed the product originally, there is a finite period of time during which they can obtain a return on their investment.
  • The changes as proposed in the draft new Regulations, while an improvement on the current situation, will not be sufficient to address the problem and to stimulate an increase in investment in innovation in the veterinary medicines sector:

o             There is no protection to support investment in existing products

o             There is no incentive to add a major species to the product (we already know +1 year for adding a new species does not work from experience with the current Veterinary Medicines Directive)

o             Maximum incentive is needed to stimulate investment in new  antibiotics- the proposals in the draft Vet Med Regulations are inadequate.

The possible solution is as follows;

•             For existing products: allow an additional 5 years protection of technical documentation for significant investments in data generated to improve an existing product such as adding on a further species.

•             Increase the additional periods of protection for both major and minor species, and consequently also the maximum attainable period of protection - the impact assessment recommended extensions of +3 years and a maximum period of 20 years.

•             Multiple species in the original dossier should qualify for the extended protection period.

•             Grant 20 years protection for the development of a new antibiotic, which would be more proportionate with the requirements for its development and the restrictions on its use.

 

Why the contribution is important

Sales value:

  • The veterinary medicines sector is a tiny fraction of the human medicines market, it is approximately 2.5% of the human medicines market based on sales value
  • It is further fragmented by multiple species.
  • This creates a tension: High investment in product development + small market = difficult to obtain a return on investment               
  • The development of new products and new active ingredients will often take place on an EU or even a global basis. 
  • In order to retain competitiveness on the global level, the animal medicines sector needs to have legislation that is supportive of innovation in Veterinary Medicines.
  • The veterinary medicines market is approximately 1/40th the size of the human medicines market and consequently in order to recoup the investment required to develop new products companies need sufficient data protection.
  • Improved protection of technical documentation is necessary to support research into new innovative products, particularly for new antibacterials to treat bacterial diseases in animals.
  • Companies cannot make major investments without adequate intellectual property protection. Investment is necessary to be better prepared to cope with new animal disease outbreaks.

by Donaljmurphy on January 05, 2016 at 03:19PM

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