As we all know, Europe is the biggest research network in the world—bigger than China and America; and the UK and, within the UK, Scotland have been major beneficiaries. As the shadow Health Minister mentioned, the EMA provides a single licensing system, and countries outside Europe that are not major economies, such as Canada and Australia, face a delay of six months to a year in accessing and licensing new drugs. The EMA is not just a licensing body, however; it also funds and promotes research, particularly into rare conditions and childhood diseases.
Europe created the comprehensive trial regulation system with the clinical trials directive in 2001 and the good clinical practice directive in 2005. As mentioned, however, in 2014 a new directive introduced the EU clinical trials information system and the new trials regulation system, which will be under the control of the EMA when it comes into force next year. The system will provide a single portal for sponsors to register, collaborate and analyse their work and will provide work spaces for authorities and a public site that will tell patients what trials are going on and what their benefits are. It will also contain the EudraVigilance database on medicinal products that are not yet licensed, which is critical during initial trials.
The MHRA will take on the full role of clinical trial regulation, including legislative functions currently carried out by EU bodies, which will obviously mean additional work and costs for the MHRA. I welcome the Government’s commitment to align closely with the new European regulations, but this is not the same as being part of a single collaborative system. I note that the UK Government plan to recognise sponsors in the EEA, since EEA states will be recognised as approved countries—this is one of the amendments made—to minimise upheaval, but that means there will not be any compulsion to have a legal representative or lead researcher here in the UK.
Clinical trials sponsors must report any suspected unexpected serious adverse reactions—SUSARs, as they are known—to the EU database. They can currently do that from the United Kingdom, in a straightforward fashion. Similarly, any SUSARs registered elsewhere in Europe are entered in the database, so that concerns are highlighted at the earliest point during trials. Many of us will remember safety trials carried out on human subjects that resulted in major damage. It is critical that the UK does not operate in a vacuum.
Before licensing, particularly in the early stages of safety, dosage or phase 1 trials, investigational medicinal products are used. Those products are unlicensed, and, as the Minister said, they must be certified by a qualified person based in the EEA. If they are made in the EEA or in a third country, that is critical. For IMPs made in a third country, the importer must have a manufacturing and importation authorisation, and must ensure that a qualified person certifies the products before supplying it.
Unfortunately, the regulations mean that bringing a drug into the UK for the purpose of a Europe-wide trial and exporting an IMP to Europe from a UK pharmaceutical firm will introduce bureaucracy. It is bizarre to claim that there will be no additional bureaucracy. The regulations merely describe the extra licences that will be required. The MHRA will publish data on UK trials, but there is no promise that they will also be posted on the EU trials information system.
Simply creating something separate will not replace our collaboration across Europe. We are seeing duplication, obstruction and expense. I am sorry to say that those are all the enemies of collaboration—and that defines the loss that is Brexit.