Quarterly news, views and activities from the European animal health industry I November 2006
 

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Dear reader,

IFAH-Europe has been investing a great deal of time in stakeholder relations in recent months. In mid-November, the federation participated in a workshop in Brussels to present the EPRUMA (European Platform for the Responsible Use of Medicines in Animals) initiative to a wider range of stakeholders and held an information day at the European Medicines Agency in London.

As a contributor to the consultation on the Community Animal Health Policy (CAHP) at the beginning of 2006, IFAH-Europe was also glad to attend the conference on the future of the CAHP held on 7 November 2023 in Brussels. At this conference as in our contribution, we stressed the importance of a long-term strategy to tackle animal diseases. Representatives of IFAH-Europe member organisations also spoke at an EDQM symposium on avian influenza vaccination held in Strasbourg in mid October.

All these activities demonstrate that the animal health world is broader than many might imagine and that animal health has a wider impact on society than is commonly perceived. IFAH-Europe is aware of this and is thus committed to continuing to collaborate with other animal health stakeholders wherever possible.

Best regards,

Declan O’Brien
IFAH-Europe Managing Director

 

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EPRUMA responsible use initiative is introduced to key stakeholders

Participants at the EPRUMA workshop

 

On 14 November 2006, IFAH-Europe, COPA-COGECA (farmers) and FVE (veterinarians) held a workshop in Brussels to introduce the European Platform for the Responsible Use of Medicines in Animals (EPRUMA) to a number of stakeholders.

All participants - comprising farmers, veterinarians, European trade organisations linked to the agri-food sector as well as EFSA - welcomed EPRUMA as a good initiative to promote stakeholder dialogue on food chain issues in a proactive way.

Participants at the EPRUMA workshop

They provided input to the EPRUMA best practice framework for the use of antimicrobials in food producing animals, a document that the platform has been working on during 2006. Additionally, attendees suggested topics that EPRUMA could cover in the future, e.g. vaccination of animals.

The EPRUMA group will continue to communicate this initiative to partners in the food and retail industries and to consumers and will consider the possibility of organising a second workshop to obtain further feedback from organisations in the agri-food sector.

Record attendance at EMEA/IFAH-Europe info day

The EMEA/IFAH-Europe info day “Stimulating Innovation and Managing Risk in Market Access to the Veterinary Sector”, held in London on 9-10 November 2006, had a record attendance. The topics and the new format, enabling a broad discussion, attracted some 90 participants from the EMEA and its Committee for Veterinary Medicinal Products (CVMP), the European Commission and the animal health industry.

The programme comprised three main topics: risk-benefit assessment for the veterinary sector and related safety topics, as well as the EMEA bulletin board / progress with the EMEA Road Map. The recommendations and conclusions participants agreed upon will be followed-up with stakeholders.

The debates covered a broad range of issues, such as the need to differentiate the human and veterinary sectors when devising legislation and guidelines; how to do a robust risk-benefit assessment; and better regulation as a key element for implementing the Lisbon agenda. Additionally, key aspects of CVMP guidelines on environmental risk assessment and user safety for pharmaceutical products were reviewed.

The EMEA informed attendees of new developments and activities, such as the EMEA Road Map, new procedures, transparency, CVMP reflections on 3Rs policy (replacement, reduction and refinement) and alternatives to animal testing; as well as the ‘sunset’ clause*.

*: This clause refers to the rule whereby the marketing authorisation (MA) of an animal health product obtained through the centralised procedure ceases to be valid if the product is not marketed within three years of the granting date of the MA, or if a product marketed earlier is no longer marketed for three consecutive years.

IFAH-Europe participates in EDQM symposium on avian influenza

IFAH-Europe joined over 80 participants from academia, regulatory authorities and industry at the EDQM scientific Symposium “Requirements for the Production and Control of avian influenza vaccines” held in Strasbourg on the 19-20 October 2006. The key aims of the symposium were to discuss the possibility of a European Pharmacopoeia monograph for avian influenza vaccines and to examine existing regulation while soliciting the views of all interested parties.

Important issues discussed/points raised included:

  • The need to control low pathogenic as well as high pathogenic avian influenza;
  • A preventative vaccination strategy could avoid economic loss;
  • There is currently insufficient data on avian influenza vaccines for a monograph.

For more information, please see:
http://www.pheur.org/medias/fichiers/avian_influenza_symposiums_19_20_oct_2006.pdf

 

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Finnish/Austrian conference on CAHP

The European Commission hosted a conference on the future of the Community Animal Health Policy (CAHP) jointly organised by the Austrian and Finnish Presidencies of the EU on Tuesday 7 November 2023 in Brussels. The conference was a follow-up to the broad stakeholder consultations on the future CAHP, in which IFAH-Europe participated.

EU and national government officials, agricultural representatives, the animal health industry, consumers and animal welfare organisations discussed the evaluation of the CAHP and plans for the 2007-2013 strategy. In general, many present highlighted the need for the future CAHP to be more pro-active in combating animal diseases.

The European Technology Platform for Global Animal Health (ETPGAH), of which IFAH-Europe is a founding member, was mentioned by the Commission as being a key instrument in developing a forward-looking strategy for animal health research. Agricultural organisations noted the important role of vaccination in tackling animal diseases and the OIE (world organisation for animal health) emphasised the need to understand the global dimension of the animal disease threat. The European Commission stressed the need for a more harmonised and coherent European approach towards animal health, while ensuring that policy tools are adapted to the specific national environments.

For more information about the CAHP conference, please go to: http://ec.europa.eu/food/animal/diseases/strategy/november_conference_en.htm

To see IFAH-Europe’s contribution to the CAHP consultation, please go to: http://ec.europa.eu/food/animal/diseases/strategy/theirviews_en.htm

Commission announces animal health funding for 2007

European Commissioner for Health & Consumer Protection Markos Kyprianou has announced €193 million during 2007 for tackling animal diseases. The Commission funds a number of programmes that eradicate, control and monitor animal diseases including zoonoses.

Annual programmes to eradicate, control and monitor animal diseases cover among others, avian influenza, bluetongue, bovine TB, rabies, salmonella, BSE and scrapie.

To find out more about the Community eradication and monitoring programmes, please see: http://ec.europa.eu/food/animal/diseases/strategy/sanco-10414-2004_en.pdf

Animal health – outstanding issues for Romania & Bulgaria

Bulgaria and Romania are due to accede to the EU on 1 January 2007. The recently published Commission Communication on the state of preparedness of both countries for EU membership highlights a number of points that are outstanding including several relating to animal health.

Animal health concerns include:

  • The current ban on both countries exporting pigs and pork products to the EU due to the existence of classical swine fever;
  • The fact that both Bulgaria and Romania do not yet fully meet the Community requirements for the treatment and disposal of dead animals and animal by-products to protect them from TSEs (transmissible spongiform encephalopathies).

To download the Commission report, please go to: http://ec.europa.eu/enlargement/pdf/key_documents/2006/sept/report_bg_ro_2006_en.pdf

 

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Animal Pharm awards

The 2006 Animal Pharm awards were presented at a ceremony in London on 12 October 2006. Award categories include best company, best new product and lifetime achievement. IFAH members gave a strong performance at the awards with Pfizer, Merial, Bayer and Dr. Peter Holdsworth from Animal Health Alliance (Australia) among the prize winners.

Pfizer Inc. received the Animal Health Company of the Year award, while Merial won awards for Best New Livestock Product and Best Equine Veterinary Product. Bayer HealthCare was granted the Best Companion Animal Veterinary Product award and the Lifetime Achievement award went to Dr. Peter Holdsworth, CEO of the Animal Health Alliance in Australia.

Further information on the Animal Pharm awards 2006 is available at
http://www.pjbpubs.com/animalpharm_awards/index.htm



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TOPRA holds first veterinary symposium

The first TOPRA (The Organisation for Professionals in Regulatory Affairs) Veterinary Symposium under the theme of “The Impact of New Legislation” took place in Amsterdam on 3 October 2006. The event was opened by Dr Martin Terberger, Head of the pharmaceuticals unit (F2) of the European Commission’s DG Enterprise.

In the keynote session on “Innovation and market access”, IFAH-Europe’s President Brian Clark stressed the importance of a proportionate effectively policed regulatory environment, while David Mackay of the EMEA (European Medicines Agency) outlined the agency’s contribution to promoting innovation. Richard Meads (European Policy Centre) explored risk management and the risk versus benefit analysis, concluding that it should control and enable i.e. allow products to be marketed within appropriate risk management conditions. Gabriel Beechinor (Irish Medicines Board) explained the decision behind the Heads of Medicines Agencies (HMA) Medicines Availability Task Force.

Session II focused on the specific aspects of the new pharmaceutical legislation designed to improve market access. During this session, speakers recounted their positive experiences with the decentralised procedure. Session III examined pharmacovigilance, looking at the Eudravigilance system and the challenge of implementing the new requirements.

The final session was chaired by IFAH-Europe’s Technical Director Rick Clayton and covered the practical aspects of the new legislation. Speakers in this session reviewed the EMEA’s new improved scientific advice procedure, the new CMDv and CVMP (Committee for Veterinary Medicinal Products) referral procedures. Sylvie Meillerais of IFAH-Europe also presented the background to the review of the variations regulation and the animal health industry’s concerns and suggestions for the review.

For more information on TOPRA, please see:
http://www.topra.org/Resource.phx/section/index.htx

 

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