TOPRA Brexit roundtable outlines challenges for clinical development of pharmaceutical products
Posted on 24/07/2018
Delegates from healthcare regulatory affairs and interested stakeholders gathered on 19 July at TOPRA’s headquarters in London, UK, to discuss the challenges with research, development and supply of medicinal products the profession will face as a result of Brexit.
Clinical Trial Regulation
The UK’s exit from the EU on 29 March 2019 and the delayed implementation of the EU Clinical Trial Regulation (CTR – delayed from 2016 to late 2019 or early 2020 due to delays in the development of the clinical trials portal and database) adds substantial complexities to the future conduct of clinical trials in both the UK and the EU. The CTR introduces centralised submission, review and approval of clinical trial applications for all interventional clinical trials in all member states of the EU. This will mean the end of separate competent authority and ethics committee submissions in each member state of the EU, allowing for all documentation for all member states in one e-submission, coordinated review within and between each member state, and the facilitation of electronic communications.
A key aspect around the CTR is the EU clinical trials portal and database, which will allow synchronisation of processes for assessment and review. If a transitional period is agreed between the UK and EU, the UK is expected to have access to EU databases and systems until the end of that period. Ideally, there will be regulatory alignment and a co-operation agreement in the long term to ensure the UK continues to have access to the database. But if no transitional period is agreed (ie, a hard Brexit), this could negatively affect the UK’s ability to be part of Europe-wide clinical trials.
The complexity in outcomes would depend on the type of Brexit that happens. For example, if a hard Brexit occurs, the UK cannot fully implement the CTR and will have no access to the EU database from 1 April 2019. Thus it is unsurprising that the lack of progress and clarity on the Brexit negotiations are causing major concerns. Research charities such as Cancer Research UK have been working to get the issues around CTR debated within the House of Lords in the UK Parliament.
Moreover, clinical trial sponsors need timely access to clinical trials materials including, for example, raw materials or active pharmaceutical ingredients, so some form of mutual recognition agreement and customs arrangement to avoid border delays and thereby clinical trial disruption, would be desirable. This is particularly important for materials that are temperature sensitive (eg, cold chain) or time sensitive (eg, radio-isotope). However, because of the threat of a no-deal hard Brexit, the profession has been repeatedly told by EU regulators such as the EMA to prepare for the worst.
Delegates from big pharma acknowledged that they have the money and resources to prepare for a no-deal Brexit, but suggested that smaller sponsors of clinical trials may not. Moreover, if a transitional agreement is reached, the money, resource and time spent on preparing for a worst-case scenario would, arguably, be wasted.
Delegates who work as consultants also said they are finding it difficult to advise their clients on what to do. The current lack of certainty means they must advise their clients to contingency plan for a hard Brexit scenario, and some suggested that the resource costs of these preparations could would make the UK less attractive a place to conduct clinical research and could end up decimating the UK industry.
A patient’s perspective
Among those at the Brexit Roundtable was Robert Johnstone, a patient with a chronic medical condition. He was previously on the European Patients Forum, an umbrella organisation that works with patients’ groups in public health and health advocacy across Europe. He outlined what he, as a patient, is concerned about in terms of healthcare in a post-Brexit UK:
- Will I get access to the medicines and devices I need to maintain a good quality of life after Brexit?
- Will there be enough healthcare professionals and carers to look after patients like me?
- Will patients get treatment when travelling through Europe without having to pay large fees or take out expensive insurance?
- Will the UK be disadvantaged if there is a European-wide health crisis, such as influenza and Ebola?
He described the Brexit process so far as being similar to “Lemmings walking off the edge of the cliff”. He said that his concerns and fears are probably shared by all patients across the UK, and it is frustrating that reassurances cannot be given due to a lack of progress with the Brexit negotiations.
In summary, Brexit’s negative impact on the UK's clinical trials landscape seems to be inevitable and will be major. It is imperative that those within the healthcare industry and its stakeholders focus on maintaining clinical supplies during the Brexit period. The regulatory affairs profession should also be vocal in providing solutions to the many challenges that have arisen as a result of Brexit (eg, the UK could potentially adopt a different approach to clinical development and medicinal product supply). The industry has, for the past two years, discussed and planned for what the worst-case scenario could be, and it must now also seek opportunities and solutions to mitigate the impact Brexit may cause to the sector.