In this article, our Consultant from the International Policy and Market Access team in Brussels, Ali Rojo Santos, explores what the future holds for the digital transformation of the pharmaceutical sector, digging into the pharmaceutical strategy for Europe, recently published by the European Commission.
Digitalising the broader healthcare sector – Europe, we’ve heard this before.
The number of times those of us working in the Brussels bubble have heard about the “digitalisation” and/or “digital transformation” of [insert sector here] are innumerable. Whilst this is genuinely an important part of the EU policy agenda – reflected by the prioritisation of “A Europe fit for the digital age” and the Digital Strategy by European Commission President, Ursula von der Leyen – it is often complicated to move from words to action and to avoid the overuse (and on many occasion misuse) of such buzzwords.
An Ernst & Young survey recently highlighted that healthcare lags behind other industries when it comes to implementing digital processes and measures. Published more than a year before the COVID-19 pandemic, the European Commission acknowledged this issue in its Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society. Stating that the “uptake of digital solutions for health and care remains slow and varies greatly across Member States and regions”, it acknowledged the importance of further action at the EU level to accelerate the meaningful use of digital solutions in healthcare. If digitalisation of the healthcare sector had been essential before the pandemic, the pressing importance of technological advances in this field was reinforced as innovative ways of ensuring the efficiency of already strained healthcare systems were sought.
Until then, various barriers had limited the promotion of a digital revolution in healthcare, including that health is a national competence and that outdated process, such as the use of fax machines in hospitals had to be changed. Whilst private organisations might be at more advanced stages, inefficiencies still exist, as seen for example in the outdated methods of dealing with clinical trial recruitment by many pharmaceutical companies.
This article focuses on the digitalisation of an important part of the healthcare sector – the pharmaceutical industry. When speaking about advancing technological processes within healthcare, we tend to focus on the public side of health systems. However, the private sector plays a key role in promoting innovation and supporting public entities in ensuring a sustainable approach to prevention, diagnosis and treatment.
Understanding the role played by digitalisation in the pharmaceutical sector
Pharmaceutical and biotechnology companies have introduced more efficient, technology-based approaches to reduce operational costs and to improve communication systems. Digitalisation is key to survive a changing external environment, where healthcare payers and other customers are demanding more and better data on improved quality of life and treatment efficacy.
The quest to research, develop and deliver a vaccine for COVID-19 in record time has been a testament to the digital revolution in the life sciences sector. Companies may consider that the return for developing new treatments for (relatively) short-lived pandemics will not cover their investment. Efficient use of resources and streamlining processes can be achieved partly through digital solutions. Major changes in the way supply and distribution chains work, the management of clinical trials and the use of digital communication platforms have been witnessed in many companies this year, as acknowledged by the Pharma Industry Review.
Whilst COVID-19 may have accelerated digitalisation, a shift in the pharmaceutical sector’s approach to developing treatments, aligned with scientific innovation, has played a key part. As companies have moved from developing ‘blockbuster’ drugs to more personalised medicines that are tailored to smaller demographics (and even individuals), greater access to data and improved data analytics have been key.
If the benefits of investing in digitalisation are clear, why is the pharmaceutical industry lagging behind? A major obstacle is the culture of the sector, which tends to be very risk-averse. As the lives and livelihoods of people are at stake, the pharmaceutical industry is subject to major regulatory controls. This partly explains the conservative approach towards change, as companies are careful to ensure compliance. Regulatory change also moves slowly, whilst scientific and digital advances move quickly, making innovation challenging.
A European Commission that promotes digitalisation in the pharmaceutical sector – truth or dare?
In November 2020 the European Commission published the “Pharmaceutical Strategy for Europe”, which includes the importance of a technological shake-up and highlights its intrinsic nature to the growth of the pharmaceutical sector. The strategy outlines specific measures that will be implemented, digitalisation being a major theme in supporting a competitive and innovative European pharmaceutical industry.
For the Commission, improving access to health data is a way of exploiting the potential of new technologies and digitalisation. The ways in which the Commission plans to achieve this are, however, unclear.
The European health data space is part of the wider desire to build a Health Union and is to be based on three tenets: a strong system of data governance and rules for data exchange; data quality; and strong infrastructure and interoperability. Whilst the technicalities around this are expected to be included in the anticipated legislative proposal on a European health data space in Q4 2021, there are some aspects that industry should be wary about.
As EFPIA has pointed out “any rules or principles that would needlessly impede the flow of data into or out of the EU must be avoided.” However, to what extent will this be possible within the current framework? Data protection rules might have to be eased, especially in a sector such as healthcare where regulation is particularly tight. Current rules and regulations might actually be an obstacle to the more widespread use of patient data by pharmaceutical companies.
Whilst the secondary use of data is covered, the tendency has been to focus on making it available for “healthcare research” purposes (also mentioned in the strategy), which tends to cover mainly academia. The strategy highlights the desire to promote improved data exchange and use through greater collaboration between the public and private sector, including through the Innovative Health Initiative – a collaborative platform for pre-competitive research and innovation. Once again though the main beneficiaries appear to be academia, not-for-profits and SMEs. These are certainly essential to achieve innovation in the pharmaceutical industry, but one cannot forget the role of bigger pharmaceutical players that have proven to be key in confronting many of the health challenges of 2020.
Data is not the only aspect covered in the strategy in relation to digitalisation. The strategy states:
Digital transformation is affecting the discovery, development, manufacture, evidence generation, assessment, supply and use of medicines. Medicines, medical technologies and digital health are becoming increasingly integral to overarching therapeutic options. These include systems based on artificial intelligence for prevention, diagnosis, better treatment, therapeutic monitoring and data for personalised medicines and other healthcare applications.
Healthcare 2.0 is here, and the Commission is eager to make sure that all EU member states have access to novel tools to make healthcare systems efficient and aligned with the advances taking place at the scientific and technological levels. This is to be achieved through the revision of pharmaceutical legislation to “adapt to cutting-edge products, scientific developments … and technological transformation” in 2022, as well as increasing the Commission’s support for collaborative projects to promote the use of “high performance computing and artificial intelligence in combination with EU health data for pharmaceutical innovation” between 2021 and 2022.
Questions remain around the detail and whether the required cultural change will be forthcoming, alongside regulatory change. There is also the challenge of data availability for the life sciences industry, as many of the exciting developments, such as AI, heavily depend on ample datasets of good-quality information.
The Pharmaceutical Strategy is exactly that – a strategy, a top line document that provides an exciting foreword to the plans of the European Commission for the sector, and its vision for the future. The Commission has signalled its commitment to a thriving industry. This is a positive start to what hopefully involves greater support to the pharmaceutical industry to improve processes and ensure it is more efficient, digital, and technologically advanced, working for every European citizen.