Downloaded from http://veterinaryrecord.bmj.com/ on May 16, 2015 - Published by group.bmj.com
News & Reports VETERINARY MEDICINES
THE National Office of Animal Health (NOAH) has expressed its support for the main aims of the new draft EU Veterinary Medicines Regulation and Medicated Feed Regulation, but says it will continue to lobby for changes that it feels will improve the regulations, especially with regard to encouraging availability and innovation for veterinary medicines. The draft regulations, which were adopted in September and are currently going through the European legislative process, aim to increase the availability of veterinary medicines across the EU by cutting red tape and issuing more licences, and also to tackle the problem of antimicrobial resistance (VR, September 20, 2014, vol 175, p 262). NOAH, which represents the animal medicines industry in the UK, organised a briefing for the media on October 10, to outline its initial thoughts about the proposed regulations. Explaining some elements of the proposals, Phil Sketchley, NOAH’s chief executive, said that they currently did not contain any plans to decouple the prescribing and dispensing of veterinary medicines. However, this might be incorporated as they progressed through the legislative process, although the European Commission currently did not seem minded to make that change. All those currently able to legally prescribe medicines under national law would continue to be allowed to do so, he said, so it was likely that Suitably Qualified Persons would continue to be able to prescribe and supply medicines, too. Prescriptions would be limited to the amount needed for treatment. Those prescribing antimicrobials would only be able to supply them for animals under their care.
spending was £600 million per year while human spend was £13 to £14 billion), Mr Sketchley argued that, on a scale of one to 10, the likelihood of a new antimicrobial molecule being developed for the veterinary market was ‘less than one’. He added that NOAH would be lobbying to increase the amount of time all new products were protected for, not just antimicrobials, to encourage availability and innovation across the board. Because the legislation took the form of Regulations, once it was passed there would be no option for member states to change elements of it, as is possible for European Directives, explained Donal Murphy, technical executive at NOAH.
However, the Regulations would allow changes with regard to antimicrobial use, as the Commission would be able to limit or ban the use of certain antimicrobials in animals in the future should it see fit. The Regulations would also allow for the Commission to establish a list of antimicrobials that could not be used under the cascade or to limit their use under the cascade to certain conditions. Mr Sketchley said that NOAH supported the suggestion that more data on antimicrobial use should be gathered across EU member states, but was not yet clear where this data would be collected. It also welcomed plans for the European Medicines Agency to establish an EU-wide
Antimicrobials
The EU is keen to encourage new antimicrobials onto the market, and one of the measures being proposed is to increase the data protection available to manufacturers who develop new antimicrobials by four years to give 14 years’ protection (products produced for bees would get 18 years’ protection). However, Mr Sketchley said that NOAH felt that this did not ‘go anyway near enough’ to encourage innovation, and that it would like to see at least 20 years’ protection. Taking account of the current differential in spending on veterinary and human medicines (eg, in the UK veterinary November 1, 2014 | Veterinary Record | 415
t
EU must encourage medicines availability and innovation, says NOAH
Downloaded from http://veterinaryrecord.bmj.com/ on May 16, 2015 - Published by group.bmj.com
News & Reports pharmacovigilance database, which would be publicly available, but did not want to see ‘unnecessary gold-plating’.
Administrative burdens
As they stood, some of the proposals in the regulation to streamline approval procedures would not result in a truly Europe-wide marketing authorisation for all medicinal products, said Mr Sketchley. However, some improvements and reductions in the administrative burden had been proposed, which should increase medicines availability across EU member states. For example, it had been proposed that Summaries of Product Characteristics should be standardised across the EU; this would be applied retrospectively to medicines that already had licences. It had also been proposed that packaging could be harmonised across the EU by the use of standardised pictograms. This might increase product availability in smaller member states, as separate packaging would not need to be produced. He also explained that the advertising of medicines to people other than those who could prescribe them would be banned, so companies would not be able to advertise prescription medicines to farmers or pet owners. Currently, only the UK and the Czech Republic allowed advertising to non-prescribers.
Medicated feed regulation
Discussing the proposed Medicated Feed Regulation, Mr Murphy pointed out that the EU had recognised medicated feeds as an appropriate route to administer medicines. Under the proposals, such feeds would remain available by prescription only and
416 | Veterinary Record | November 1, 2014
the prescription would be restricted only to the treatment period. For food animals, the prescription would only be valid for three weeks, unless the medication was an antimicrobial, when it would be valid for two weeks. The EU had acknowledged that some ‘carry over’ at manufacture, that is, some quantity of medicines from one batch of medicated feed ending up in the next batch of unmedicated feed being produced, was unavoidable. The proposed Regulation would set limits of 1 per cent for antimicrobials and 3 per cent for other products as the maximum to be carried over into an unmedicated batch. The draft Regulation also stated that
medicated feed could not be used to prevent disease or enhance performance. Mr Sketchley explained that NOAH agreed that medicinal products should never be used to enhance performance but it did support the use of medicated feed for prophylactic purposes in some cases (under the draft Regulation metaphylactic use would still be acceptable). Member states and MEPs are expected to propose amendments to the draft Regulations over the coming months. The intention is that the final Regulations will come in to force sometime in late 2017 or early 2018. doi: 10.1136/vr.g6486
Downloaded from http://veterinaryrecord.bmj.com/ on May 16, 2015 - Published by group.bmj.com
EU must encourage medicines availability and innovation, says NOAH Veterinary Record 2014 175: 415-416
doi: 10.1136/vr.g6486 Updated information and services can be found at: http://veterinaryrecord.bmj.com/content/175/17/415
These include:
Email alerting service
Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
News & Reports VETERINARY MEDICINES
THE National Office of Animal Health (NOAH) has expressed its support for the main aims of the new draft EU Veterinary Medicines Regulation and Medicated Feed Regulation, but says it will continue to lobby for changes that it feels will improve the regulations, especially with regard to encouraging availability and innovation for veterinary medicines. The draft regulations, which were adopted in September and are currently going through the European legislative process, aim to increase the availability of veterinary medicines across the EU by cutting red tape and issuing more licences, and also to tackle the problem of antimicrobial resistance (VR, September 20, 2014, vol 175, p 262). NOAH, which represents the animal medicines industry in the UK, organised a briefing for the media on October 10, to outline its initial thoughts about the proposed regulations. Explaining some elements of the proposals, Phil Sketchley, NOAH’s chief executive, said that they currently did not contain any plans to decouple the prescribing and dispensing of veterinary medicines. However, this might be incorporated as they progressed through the legislative process, although the European Commission currently did not seem minded to make that change. All those currently able to legally prescribe medicines under national law would continue to be allowed to do so, he said, so it was likely that Suitably Qualified Persons would continue to be able to prescribe and supply medicines, too. Prescriptions would be limited to the amount needed for treatment. Those prescribing antimicrobials would only be able to supply them for animals under their care.
spending was £600 million per year while human spend was £13 to £14 billion), Mr Sketchley argued that, on a scale of one to 10, the likelihood of a new antimicrobial molecule being developed for the veterinary market was ‘less than one’. He added that NOAH would be lobbying to increase the amount of time all new products were protected for, not just antimicrobials, to encourage availability and innovation across the board. Because the legislation took the form of Regulations, once it was passed there would be no option for member states to change elements of it, as is possible for European Directives, explained Donal Murphy, technical executive at NOAH.
However, the Regulations would allow changes with regard to antimicrobial use, as the Commission would be able to limit or ban the use of certain antimicrobials in animals in the future should it see fit. The Regulations would also allow for the Commission to establish a list of antimicrobials that could not be used under the cascade or to limit their use under the cascade to certain conditions. Mr Sketchley said that NOAH supported the suggestion that more data on antimicrobial use should be gathered across EU member states, but was not yet clear where this data would be collected. It also welcomed plans for the European Medicines Agency to establish an EU-wide
Antimicrobials
The EU is keen to encourage new antimicrobials onto the market, and one of the measures being proposed is to increase the data protection available to manufacturers who develop new antimicrobials by four years to give 14 years’ protection (products produced for bees would get 18 years’ protection). However, Mr Sketchley said that NOAH felt that this did not ‘go anyway near enough’ to encourage innovation, and that it would like to see at least 20 years’ protection. Taking account of the current differential in spending on veterinary and human medicines (eg, in the UK veterinary November 1, 2014 | Veterinary Record | 415
t
EU must encourage medicines availability and innovation, says NOAH
Downloaded from http://veterinaryrecord.bmj.com/ on May 16, 2015 - Published by group.bmj.com
News & Reports pharmacovigilance database, which would be publicly available, but did not want to see ‘unnecessary gold-plating’.
Administrative burdens
As they stood, some of the proposals in the regulation to streamline approval procedures would not result in a truly Europe-wide marketing authorisation for all medicinal products, said Mr Sketchley. However, some improvements and reductions in the administrative burden had been proposed, which should increase medicines availability across EU member states. For example, it had been proposed that Summaries of Product Characteristics should be standardised across the EU; this would be applied retrospectively to medicines that already had licences. It had also been proposed that packaging could be harmonised across the EU by the use of standardised pictograms. This might increase product availability in smaller member states, as separate packaging would not need to be produced. He also explained that the advertising of medicines to people other than those who could prescribe them would be banned, so companies would not be able to advertise prescription medicines to farmers or pet owners. Currently, only the UK and the Czech Republic allowed advertising to non-prescribers.
Medicated feed regulation
Discussing the proposed Medicated Feed Regulation, Mr Murphy pointed out that the EU had recognised medicated feeds as an appropriate route to administer medicines. Under the proposals, such feeds would remain available by prescription only and
416 | Veterinary Record | November 1, 2014
the prescription would be restricted only to the treatment period. For food animals, the prescription would only be valid for three weeks, unless the medication was an antimicrobial, when it would be valid for two weeks. The EU had acknowledged that some ‘carry over’ at manufacture, that is, some quantity of medicines from one batch of medicated feed ending up in the next batch of unmedicated feed being produced, was unavoidable. The proposed Regulation would set limits of 1 per cent for antimicrobials and 3 per cent for other products as the maximum to be carried over into an unmedicated batch. The draft Regulation also stated that
medicated feed could not be used to prevent disease or enhance performance. Mr Sketchley explained that NOAH agreed that medicinal products should never be used to enhance performance but it did support the use of medicated feed for prophylactic purposes in some cases (under the draft Regulation metaphylactic use would still be acceptable). Member states and MEPs are expected to propose amendments to the draft Regulations over the coming months. The intention is that the final Regulations will come in to force sometime in late 2017 or early 2018. doi: 10.1136/vr.g6486
Downloaded from http://veterinaryrecord.bmj.com/ on May 16, 2015 - Published by group.bmj.com
EU must encourage medicines availability and innovation, says NOAH Veterinary Record 2014 175: 415-416
doi: 10.1136/vr.g6486 Updated information and services can be found at: http://veterinaryrecord.bmj.com/content/175/17/415
These include:
Email alerting service
Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
