The European Federation of Pharmaceutical Industries and Associations’ Andy Powrie-Smith speaks to SciTech Europa about the organisation’s vision for the future – a vision based on accessible innovation in the healthcare space.
With a direct membership of 36 national associations and 40 leading pharmaceutical companies, the European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Its mission is to create a collaborative environment that enables its members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. EFPIA’s vision is for a healthier future for Europe.
SciTech Europa spoke to the European Federation of Pharmaceutical Industries and Associations Communications Director, Andy Powrie-Smith, about this vision and what needs to be in place for it to be achieved.
The #WeWonRest campaign aims to ‘make the world a healthier place for everyone’. This, perhaps, begins with drug development. How would you characterise this landscape in Europe today?
We are now in an era where there is a lot to be excited about when it comes to the rapidly advancing science taking place across the board. Areas such as data analytics, genomics, and cell editing therapies, for instance, are evolving very quickly and we are seeing their benefits.
At the same time, there are numerous challenges involved in how we encourage and innovation, and how we introduce some of these technologies into healthcare systems. To overcome these hurdles, we need to develop a more collaborative approach.
From the development side, we perhaps need to recognise that we are a part of a global competition for investment in R&D for the pharmaceutical industries , and that the USA, and indeed Japan and China and others, have been moving forwards very quickly in recent years. There are a number of factors involved in what that means for Europe and how we address those.
The first is with regard to the regulatory space, and we need to understand how our regulatory environment can keep pace with that rapidly advancing science. We are now seeing carefully targeted medicines with smaller patient cohorts, the emergence of real world evidence and so on, and we need to now incorporate those into our regulatory processes for pharmaceutical industries.
The European Medicines Agency (EMA) is the key body here. However, they are, of course, currently relocating from the UK as a result of Brexit which means that their current capacity has been a little diminished. As such, we need to think about how we can support the EMA in advancing on the regulatory side, at least for the time being.
Another relevant area is the intellectual property environment for Europe. The European Commission has been conducting an analysis of the current pharmaceutical incentives, particularly in areas such as orphan medicines and paediatrics regulations, and one of the key drivers in investment in research is an IP framework that allows companies to enter into the long, complex, and high risk process of drug development with confidence.
At the global level, many regions are now strengthening their IP frameworks. At the same time the EU has started to look at introducing, for example, manufacturing waiver around supplementary protection certificates (SPCs), and there is a sense that this sends out the wrong signal and suggests that Europe is potentially weakening its IP framework. This is a real areas of concern for us at EFPIA in terms of Europe’s innovative industry.
Finally, there is no doubt that there is a very strong history of innovation and drug development in Europe, and we want to make sure that there carries on into the future.
What could be done to minimise the extent to which this waiver affects the IP framework in Europe, should it come into force?
The export waiver, which is a potential devaluing of the current IP rights, still has a few legislative hurdles to overcome, but if it is put in place then it is important that it is implementation in such a way that the impact is minimised. For instance, the date of implementation will be important due to the fact that investors around the world have invested in drug development in Europe on the basis of the IP rights that they understood at the time. As such, it is crucial that any waiver only applies to SPCs that are put in place after the date that the waiver is implementation of the waiver, and certainly not retroactively.
In addition, this will be a waiver for export, and so we need to ensure, when it comes to markets where the SPC has expired or there is no IP protection in place, that things are put into place (such as appropriate labelling) so that things designated for export don’t end up back in the EU.
We need clarity, transparency, and legal certainty around these issues to minimise the damage; the signal, unfortunately, has already been sent, but there will be a lot of scrutiny from investors globally in terms of R&D about how it is now implemented as we move forwards.
How would you like to see the EU’s legislative landscape evolve in order to speed up the bench-to-bedside process whilst maintaining safety?
In the USA, much work has been done to see how we can get things like advanced therapies to patients safely and faster, and we perhaps have to think about how we can utilise the advances that have been made in things like real world evidence to enable us to follow suit. Looking at and developing those processes is something of a process of continuous development.
We also need to look at areas of unmet medical need, specifically around issues such as antimicrobial resistance (AMR), for example. When we look at the available incentives here, then an analysis of what these are and of the financial models that can drive investment and research into such areas of unmet medical need represents an opportunity, and it wold be great to see Europe take a lead in that area.
The development of new antibiotics, or lack thereof, is a multifaceted issue. What do you think are the main reasons why big pharmaceutical companies are refusing to work in this space, despite the significant societal need?
Essentially, the ideal future would see the development of a range of new antibiotics, but they would only be used when absolutely necessary, meaning that they would more than likely be shelved for a considerable amount of time before their widespread roll out. A pharmaceutical company, therefore, is unlikely to go through the 12 years of drug development and invest enormous amounts of money with the ambition of not then using that medicine. It makes no business sense.
Currently, there is a market issue on how companies are incentivised. If you are a small biotech company and are trying to get investment into a promising lead around developing a new antibiotic, but the potential investors see the ultimate ambition is that it sits on the shelf for as long as possible, then clearly that’s a difficult sell. It is therefore fundamental to be able to provide some kind of alternative incentive, rather than one based on the volume of sales, in order to incentivise R&D.
Another area that is relevant here is the collaborative research space. Enterprises like the Innovative Medicines Initiative (IMI) are able to bring together different organisations, academia, different parts of the life sciences sector, and others to tackle different difficult scientific challenges. The IMI recently celebrated their 10 year anniversary, and looking back on its history it is fantastic to see some of their successes, such as discovering new biomarkers, developing vaccines for Ebola in record time, and so on.
The IMI potentially provides a model to look at some of these issues again: are the incentives aligned to what we needs to happen? And what is the model for collaborative research to tackle an issue such as AMR, which is one of the biggest current potential public health challenges? What can we do to come together, to pool our expertise and resources, and achieve results faster?
The drug development process is time consuming and expensive, and a lot of the drugs that make it to clinical trials don’t get any further. How can the European Union adjust to better mitigate risk?
The IMI is again a good example here as this was, at least in part, why the IMI was created. There are clearly some big challenges in the way of drug development, but we are talking about life-saving or life-improving, and so there is more that can be done.
Collaboration in the pre competitive space through things like IMI are very helpful and are proven to get results. Again, we could look at the regulatory processes that are in place and the time it takes to develop new pharmaceuticals. There may be scope, for instance, to evolve those processes to match the way that science is moving.
There are also some interesting things which could be explored around clinical trials in Europe in an effort to make Europe a world leader here. These include:
- Currently, patients are screened for a specific clinical trial by the organisation/company conducting it, but there may be a way to integrate all of the screening processes together. That is, if a patient does not match the criteria for one trial, then they could be put forward for another which they are eligible for because the data would already be there. Such an integrated screening initiative would be much better for patients;
- Continuing to update clinical trial design, particularly by using some of the digital tools that are now available, could be used to ensure that Europe is at the forefront of clinical trials practice; and
- Our ability to connect health records and data with data emerging from not only clinical trials but also the use of medicines in terms of real world evidence will be crucial in being able to begin interrogating that data to find maybe, perhaps, answers to questions we haven’t even thought asking yet.
The evolving societal and healthcare challenges as well as opportunities offered by new sciences and technologies, call for a much more integrated health research environment than in the past. How is the EFPIA working to achieve that?
It is absolutely right to say that a more integrated health research environment is required moving forwards. The challenges being faced by healthcare systems and patients in Europe, particularly with regard to such issues as the ageing demographic, are such that no single sector alone will have all the answers. As such, collaboration and new ways of working in partnership, and convergence between life sciences sectors (especially with regard to fields such as diagnostics, imaging, pharma, biologics, and so on), are going to be extremely important to achieving that.
From an EFPIA perspective, initiatives like the IMI, which bring together many diverse elements, including research, academia and industry, are really very important here. Other similar projects will have a role to play, such as the European Health Data Network, for example, which is working to connect hospital sites from across Europe to try and better understand the data and so continue to advance patient care.
How we work with the EMA and academia and others on the regulatory side should also be considered EFPIA is involved in important collaborators with all of these at the moment. These relationships are things we also want to see evolve moving forwards.
The EU Health Summit, which took place in October in Berlin, Germany, saw almost 30 European healthcare organisations as well as delegates from hospitals, the researcher sector, patient organisations, policy, and industry, all come together to look at what health and health research looks like, and, indeed, what it will look like in the future (bearing in mind that a new college of European Commissioners will take their seats in 2019). Events such as this are an example of how a shared vision for health, and, indeed, a shared vision for research, can be developed and where the sum will be greater than the parts.
Europe can continue to play an important role in both in health and in health research, and if we look forwards to the new Commission, we know that citizens across the EU really value an active role on the part of the EU within both of these areas, and we want to ensure that we can make the most of the EU’s potential.
What is the EFPIA’s vision ‘for a brighter tomorrow’?
For me, that is a future based on innovation and on patients having access to that innovation.
We are already making progress towards more outcome-focussed healthcare systems, and we are identifying the things that really work and which give the most value to patients, while we are also identifying the things that don’t, and we then are disinvesting in them.
This is all predicated on having healthcare data that can provide answers and solutions to the challenges we face, such as the ageing population, which is already seeing increased incidences of things like dementia, for which the overall costs to society is huge.
We need to understand that we have to take one of two options: we can either carry on as we are and as we always have, which is not very attractive; or we can focus on innovation.
If we look at the history of healthcare, it is typically innovation which has held the key to how society manages a big healthcare issue. As such, there is a clear need to continue to advance medical innovations in Europe. However, innovation without access will have no real impact, and so this will need to be taken into consideration. Of course, we also understand the pressures on healthcare systems, and so we need to ensure that healthcare is affordable now and sustainable in the future. If we do that, then we need to do that around a system that is based on outcomes.
Executive Director of Communications & Partnership
The European Federation of Pharmaceutical Industries