Steve Hoare, Quality Regulatory Science and Safety Policy Director at The Association of the British Pharmaceutical Industry (ABPI), discusses the impact of Brexit and COVID-19 on the pharmaceutical industry and how industry continue to evolve.
Q: Could you tell our readers a bit about your background and how you came to join the ABPI?
A: I started my career as an analytical chemist in quality control, progressing to lead large quality teams. I have worked end to end, from discovery to distribution, as well as on devices, small molecules and natural products. I have also led change management and continuous improvement initiatives within my roles. My background is as a generalist with broad experience; this is an excellent fit with my role at ABPI. I joined ABPI three years ago and I have found my home here in this role, where I translate the impact of guideline changes on the industry. I have a huge extended team across the industry, which includes subject matter experts that I can tap into. I fell into this role where I am now effectively representing the UK pharmaceutical industry. In this role I can make a difference and see the impact that we make.
Q: Can you describe the role of the ABPI and your specific role within the association?
A: The ABPI exists to make the UK the best place in the world to research, develop and use new medicines. We represent over 60 research-based pharmaceutical companies across the UK. Every job created in pharma creates 2.2 jobs in other industries in the UK; therefore, the association supports UK businesses. Within my role, I represent the operational side of ABPI. I educate on the impact of new regulations on industry and manufacturing. This leads to a huge variety in my daily activities and there is never a dull moment. On my first day, I found myself in a very topical and strategic meeting with the MHRA. I quickly realized that my role is not to contribute to the technicalities of the regulatory process, but to turn it into a language that a lay person could understand. This is so a government minister or a stakeholder, without a science or regulatory background, could be briefed on regulatory affairs.
We need to ensure that the UK has regulations where patient safety is key, whilst securing guidelines that are effective and workable. A big part of my day is spent listening to member concerns and turning them into case studies. These in turn can be shared with regulators or policy holders, to influence the outcome of final regulations by showing its real world and human impact. I have empathy for my regulatory affairs colleagues across the UK. I know you work in a high-pressure role, which requires a huge team effort to get submissions out of the door. Within my role, I need to help establish guidelines that do not hinder this process.
…the ABPI is working to make the UK life sciences industry a superpower in the 2020s
Q: The ABPI has shared its ten year strategy, can you tell us more about this and what you think are the biggest benefits and challenges in achieving this?
A: The idea behind the ten year strategy is to drive the big picture and long-term vision of the ABPI. It was a huge team effort within the association and involved interviews with lots of members and stakeholders. The strategy will be used to underpin our planning, objectives and budgeting in the coming years and ensure that we are outward looking and have measurable goals. We want to ensure the ABPI continues to add value and deliver. The strategy is scary and challenging for us as it is a new approach for the ABPI. If we do not deliver, it will be visible to our members. However, there are huge benefits to patients if we can drive the UK towards being the first regulatory market for the approval and participation in clinical trials, which benefits both patients and the NHS. Year-on-year, the public perception of the pharmaceutical industry is improving and we will continue to build on this. The pandemic has seen the pharmaceutical industry being associated with positive outcomes and I am very proud to be part of this industry.
Q: How did Brexit impact the ABPI and medicines in the UK?
A: The ABPI was working for several years before the actual transition occurred and continues to support the industry regarding Brexit today. I see every day how we are making a huge, positive difference to UK pharma and to our individual members at ABPI. I went into pharma to make a difference and I feel that I am really doing that in this role. Prior to the transition, we were in meetings with over 200 people from quality, regulatory and pharmacovigilance from across the UK and they were all desperate for information. It is important to remember that it was a positive outcome to obtain a deal. Supply chains remained secure with regulatory flexibility and the necessary goods were stockpiled, which was a successful precaution. We continue to work on the regulatory and supply chain areas affected by Brexit and have also applied our learnings to the pandemic. Medicines were propelled into the public domain, with a lot of focus in the lead-up to transition. We are proud of how the industry managed this and retained supply to UK patients. The ABPI worked closely with the Department of Health, HMRC and the MHRA to manage the regulatory process and customs and border checks for EU supply. It remains too early to tell the full long-term impact of Brexit, but the ABPI is working to make the UK life sciences industry a superpower in the 2020s.
Q: From your view how has COVID-19 impacted the pharmaceutical industry?
A: The pandemic is a global tragedy and Brexit had helped us to rehearse for the challenge of managing regulatory and supply chain activity during COVID-19. The pharmaceutical industry became a front and centre solution and the response to this has been phenomenal. The fact that we now have fully approved vaccines rolled out across the UK, coupled with the speed of their development as well as ABPI members becoming household names is extraordinary. At the start of the pandemic, we saw a supply challenge caused by the infection level and companies’ responses to the calls for help restored my faith in humanity and was a very moving experience. An ABPI helpline was set up to coordinate support and it was overwhelmed by people who wanted to help.
Some examples that have really stuck with me include companies offering their full sales force to deliver medicines to patients and an individual who offered himself and his bike to deliver medicine and supplies across London. People shared ideas on how we could develop diagnostic tests for COVID-19 and collaboration happened across many different companies. The MHRA had a very positive response and very quickly started looking at flexibilities to support the industry. They were sharing their ideas before they became guidance, showing a strong trust between regulators and UK pharma. I represent operational teams and would like to say a huge thank you to those people in manufacturing, warehouses and supply chains. They had to very quickly adapt to different and challenging ways of working, to continue supply to patients in the UK and around the world.
There has been a huge impact on the NHS caused by the clinical trials that were stopped during the pandemic. This has led to concerns about future medicine development. ABPI colleagues have put significant effort into policies supporting the NHS, to get them back on track to ensure that we have a pipeline in place for the future. The pandemic and its impact is not yet over, but it has shown what can be achieved. It has paved the way for the accelerated processes that the industry was looking for, without compromising on patient safety. As we look forward, the MHRA is reviewing the new flexibilities that were introduced, with a view to embed regulation and guidance as business as usual. This is so we can learn for the next pandemic and to set a path for the UK to move forward after Brexit and COVID-19.