I am most grateful to all noble Lords for their contributions. We will consider another SI which is yet to clear JCSI. I want to put on record that I am fully seized of the point that statutory
instruments should be grouped together wherever possible, appropriate and helpful to your Lordships in scrutinising regulations.
Although I mentioned it in my opening remarks deliberately, I emphasise again that this SI is absolutely about continuing existing high standards for veterinary medicines and ensuring that UK businesses and individuals can continue to access as wide a range of veterinary medicines as possible. I specifically reassure the noble Baroness, Lady Jones of Whitchurch, that there is no way that this statutory instrument can do anything to unpick the existing ban on hormone growth promoters, as it is already in UK law. I repeat emphatically that this is not the purpose or intent of these regulations.
A number of your Lordships mentioned the requirement for marketing authorisation holders to be established in the UK, which will result in a small additional cost—there are references to £100 and a further annual fee of £40. We believe it is necessary to ensure the safety and effectiveness of UK medicines and that all companies can be held accountable for the medicines they market. We have endeavoured to make this process as simple and robust as possible. The cost of establishing a UK presence is small compared with the overall cost of developing a medicine and bringing it to market. We do not believe that companies will be discouraged from bringing their products to the UK market. All new companies wishing to market products in the UK may continue to manufacture medicines in Europe and elsewhere, but as a company they must be established here in the UK.
The noble Lord, Lord Addington, is right that we considered alternatives when preparing this in order to provide the same assurance that the products in question are safe and effective. Final manufacturing and product surveillance assurance processes would have been required to take place in the UK under that alternative. That would mean moving manufacturing processes and staff and would certainly have resulted in significant increases in costs to industry. This is why we chose the option that we believe provides the necessary assurances that we would require with the least impact on and cost to business. As the noble Lord, Lord Trees, said, it is a reasonable and proportionate response to what these instruments intended.
My noble friend Lady McIntosh raised the issue of UK companies wishing to market products in the EU. At this stage, the European Medicines Agency has been clear on its expectations. Marketing authorisation holders, final manufacturing certification and post-authorisation surveillance must all be located in the EU. As I have said, our approach has been somewhat different. We have intentionally intended to be pragmatic. We think that is the right way forward. On whether there will be any changes in the arrangements, this is the position as we understand it at the moment. I think this is an area where continuing collaboration is important.
I profoundly agree with the noble Baroness, Lady Jones of Whitchurch, about the imperative of reducing the use of antibiotics in livestock. We must reduce it in humans too. In livestock, there has been a 40% reduction already. We need to go further for all the reasons we understand about animal and human resistance.
4.45 pm
On working with industry, there has been considerable engagement with NOAH and the Veterinary Pharmacy Association, and officials from the Veterinary Medicines Directorate are having continuous meetings with key industry representatives. As I have said, industry representatives have said to me that they welcome this continued and proactive engagement.
In response to the noble Baroness, Lady Jones of Whitchurch, I have had no indication from the industry that companies have decided not to continue marketing products in the UK. Indeed, we are a nation with considerable livestock and animal interests as animal lovers. The UK animal medicines market is worth in excess of £645 million per annum. The additional costs which will result from this regulation have been acknowledged by many of those I have spoken to as being very small compared with the extremely high costs of developing and marketing veterinary medicines. The whole point of this statutory instrument is to ensure that this country has the appropriate medicines we need to look after animals.
Bad practice was another point raised by the noble Baroness, Lady Jones of Whitchurch. Broadly speaking, it means operating outside the scope of the regulatory regime. In this context, that would include failing to report adverse reactions to the VMD or changing a product specification without going through the necessary regulatory approvals. I have not been made aware of any examples of such practices, but if I do hear of any, I will write to the noble Baroness and send a copy to all noble Lords who have spoken in the debate. This is an important feature of the necessary regulatory approvals. We should ensure at every turn that if there are adverse reactions or if there is a change in a product specification, the VMD must be informed.
My noble friend Lady McIntosh asked about the cost of placing products in the EU. As I understand it, the reality is that costs will vary across member states. Due to the complexities of the products, member states are able to set their own fees depending on the number of countries involved and the costs incurred by the individual assessment authorities. I cannot give precise figures to assist my noble friend but, again, if I have any further detail, I will be in contact.
This is about bringing these matters back into the national context and ensuring that there is confidence that it is done robustly. The noble Baroness, Lady Jones of Whitchurch, asked about the scrutiny arrangements of Ministers. The Veterinary Medicines Directorate is the UK’s competent authority for veterinary medicines and authorises medicines on behalf of the Secretary of State. There is an established statutory appeal mechanism set out in the Veterinary Medicines Regulations 2013 for anyone who is aggrieved about a decision made under those regulations. This instrument does nothing to reduce or diminish those protections. Regulation 28 of the 2013 regulations provides for an appeal to be made to the Veterinary Products Committee while Regulation 29 provides for an appeal to a person appointed by the Secretary of State to hear the appeal. Once these routes of appeal have been exhausted, the applicant may bring forward judicial review proceedings in respect of the Secretary of State’s final decision.
It is important to emphasise that the VMD is recognised across the EU as having considerable experience and a very strong scientific standing. It is acknowledged across Europe as one of the best-performing national EU regulators. It already undertakes a substantial amount of scientific assessment work, the majority of which takes place at national level, so there is a high degree of continuity. Indeed, the VMD has an excellent reputation not only within Europe, but internationally based on the strength of its scientific and regulatory expertise. The industry across the EU uses VMD as one of the lead agencies because of its reputation for excellence.
On scientific expertise and advice, it is important for me to express that in the national context, we will be well protected. VMD already has considerable expertise, but it also has access to independent advice and can draw on the expertise of the UK’s Veterinary Products Committee. The committee’s membership includes academics with expertise in ecotoxicology, toxicology, the fate of veterinary medicines in the environment and residues in food. In other words, we believe that considerable expertise is already available to us.
The noble Lord, Lord Trees, mentioned consistency. VMD co-ordinates on a UK-wide basis and meets all DAs yearly to set the annual residues control plan to ensure consistency. More generally on all these matters, in the framework and understanding in respecting the devolved arrangements, the common link and common standards, particularly in areas such, as this are well understood by the devolved Administrations. As I said, their engagement was very much alive on this instrument.
My noble friend Lady McIntosh asked about authorisation costs. In the UK, the costs will remain the same. The noble Baroness, Lady Jones of Whitchurch, mentioned product quality. There are no specific concerns about any of the products from holders currently based outside the UK but, clearly, we need to ensure robust assessment to keep animal and human health safe.
Other points were made. On our arrangements and approach, which I described to the noble Lord, Lord Addington, I say to my noble friend Lady McIntosh that we do not wish there to be any barriers to trade. We wish to collaborate and work to ensure that animal medicines are available in this country. In working with NOAH and industry, everyone is seized of the importance of this issue. I will study Hansard because I want to respond to the noble Baroness, Lady Jones, with specific details on mutual batch-testing.
In our arrangements with the EU, we all want a deal that reflects the importance of collaboration. That is precisely because in this country, we have expertise that the Europeans wish to use and we in turn wish to work with them. This is a strong area in which we wish to work collaboratively.