Despite concerns that the UK could be left behind as pharma companies look to conduct clinical research and approve new drugs in larger markets, there are reasons for optimism.

The global trend within medicines regulation is increasingly for the leading agencies to work more collaboratively and mutually recognise activities and approaches. The Medicines and Healthcare Products Regulatory Agency (MRHA) is currently responsible for 40% of the testing that the EMA undertakes. It is highly likely that some degree of mutual recognition will be achieved given the positive precedents between agencies such as USFDA, EMA, Swiss Medic etc.

Despite uncertainties, we conjecture that post Brexit, the MRHA will continue to be a beacon of scientific excellence and a juggernaut in setting up trade agreements with the US, Middle East and Asia, retaining the UK’s appeal as a key market for clinical research and drug development.

I view Brexit as a real opportunity for the UK to shake off unnecessary bureaucratic restraints, showcase its excellence in both research and medicine, and use it to the benefit of bio-pharmaceutical and academic-driven research in the medical arena.

The UK may not be able to compete with the US and China in a purely patient numbers game in clinical trials, but the way medicine is practiced here, and the highly connected nature of our systems means we can offer something really appealing to a global marketplace in more complex trials – such as CAR-T Cell therapies, immuno-therapeutics or those requiring long-term patient follow up.

If Britain wants to play in the global field why not take this chance to rebuild global credentials, lose some of the shackles of bureaucracy, which have bedeviled both clinical trials and drug safety legislation in Europe, and do something creative while protecting patients?”

Amongst the many regulatory implications for the life sciences sector, Brexit has created uncertainty about the future legal status of the new CTR in the UK. The CTR was adopted and entered into force back in 2014, but will not apply until six months after the European Commission confirms that the new EU clinical trials portal and database are fully functioning.

Currently the expected date of CTR application is March 2020. Had the application date been prior to Brexit, the CTR would have been automatically implemented into UK national law by the EU (Withdrawal) Bill. However, the UK cannot unilaterally legislate to have access to EU systems and structures, including the new EU clinical trials portal and database. Access will require agreement from the EU as part of the negotiations on the future trading relationship between the UK and EU.

If the EU CTR application date occurs after Brexit but before the end of the proposed transition period (30 March 2019 to 31 December 2020), under the current draft of the Withdrawal Agreement the UK would have access the portal and database. Beyond this, continued access would need to be agreed with the EU and the UK would have to pass separate legislation to implement the CTR into UK law.

A low-ambition, overly cautious Brexit deal on pharma would create serious legal barriers to continuing large-scale clinical trials in the UK.

We could see investigational medicinal products delayed in getting to trial sites, the duplication of good clinical practice inspections, and UK-authorised medicines barred as EU reference products.

That would lead to delays, extra costs and a serious fall in the contribution of UK clinical trials to R&D in Europe.

To avoid that, the pharma industry and individual companies should engage with both the UK and the EU sides to urge a solution which provides for:

• Full regulatory alignment on medicines and medicinal products, so both sides can have confidence that standards are maintained;

• An ambitious agreement on the movement of people so the industry has access to the talent it needs within and across borders; and

• Frictionless trade.

Because the diseases that cause dementia progress slowly, it is difficult to identify people with key hallmarks of disease.

This means clinical trials for dementia treatments can be lengthy and often require very large populations. Therefore, it’s vital we can continue collaborating and sharing data with our European colleagues post-Brexit.

Consistent regulation of clinical trials is a key part of being able to collaborate. We must also have protected avenues to share information across borders.

This is particularly important in progressing research into the rarer forms of dementia, which have smaller population sizes and often require pooling samples or gathering people from multiple countries for studies.

Andrew Ng, a renowned computer scientist and former CSO at Baidu, once told me that tasks a typical person can do with no more than one second of thought may be automated with artificial intelligence now or in the near future. This suggests that in hearing healthcare, some tasks may be ripe for automation.

In fact there have already been attempts to automate routine audiometry. In the case of air-conduction hearing aids, we have already transitioned from manual program changes to adaptive signal processing that detects and automatically adapts to the dynamic listening environment. Advances like these have not replaced human professionals, however. In fact some of them have helped hearing healthcare professionals be even more successful.

Counseling is one crucial aspect of hearing healthcare that seems beyond the near-term reach of automation. While virtual personal assistants may leverage language models and acoustic models to function in simple use-cases, and emotion detection may mature to reliably recognise extremes, the empathetic counseling provided by hearing healthcare professionals ensures their job security. Complex decision-making based on subtle cues among a highly variable spectrum of patients will keep hearing healthcare professionals in business for years to come.