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The AI revolution in healthcare will need new regulatory pathways

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Smart regulations that encourage investment in AI are needed to ensure everyone gains the healthcare benefitsCredit: everything possible/ Shutterstock

Artificial intelligence (AI) will transform research and healthcare services, promising to bring many new therapies. Most investments in AI currently involve large US pharmaceutical companies. However, Europe has its own success stories, mostly linked to supportive government plans. In Italy, new technologies such as AI are an integral part of health investments within the National Recovery and Resilience Plan (PNRR). Farmindustria president, Marcello Cattani, explains why investing in digital innovation will benefit the whole of Europe.

AI systems are developing rapidly. When will we see the benefits?

We are already seeing new technologies bringing improvements in pharmaceuticals: digitalization in R&D has reduced the time for discovery and development of drugs; automation in manufacturing has increased the efficiency and quality of new therapeutics. In both these areas, further technological development, including introduction of AI, will bring even more improvements. Technologies that promote health, so-called digital therapeutics, need a slightly different scenario. These still require a regulatory and infrastructure pathway before we will be able to see the benefits of AI.

What is the potential benefit of AI?

In an interconnected world, we must support health without the need for people to leave their homes. This will be possible thanks to apps and digital therapeutics. We should focus on maximizing the productivity of our resources. Once we are on track with this, then technologies assisting human intelligence will be able to elaborate patient data to identify potential risks and to increase the ability of our healthcare professionals — who will always be the crucial actors — to develop treatment plans.

How will the use of apps for health affect people’s privacy?

I believe that the data of a single person must always be protected. However, the power of population data is essential to learn about health dynamics. In Europe, there is a rigid privacy vision. This protects the individuals when they are healthy, but also risks stopping new technologies from improving the population’s health. We need to find appropriate ways to allow the secondary use of data and introduce technical measures such as anonymization.

COVID-19 showed that innovation is essential. How can national and European regulation support innovation in the pharmaceutical industry?

The pandemic taught the world that investments in health and medicine generate benefits that vastly surpass their cost. We need to have policymakers on board, especially in an era of fierce global competition for investment in life sciences. European politics reflect the complexity of 27 countries and 27 different cultures, but also the strength of the largest welfare system worldwide. We need a European Commission more in favour of industrial development and investments. Legislators need to talk and listen to those who invest and produce. In Europe, the pharmaceutical industry has the highest value-add per person employed. We want to contribute to the discussion, respect the roles, and raise the innovation bar. Restrictive regulations obstruct new medical benefits. To be ready for the AI revolution, we need legislation that favours investment in R&D and commercialization of new technologies.

What is the situation for AI in the Italian pharmaceutical industry?

Italy has all the skills and resources needed, in both public and private sectors, for innovation and development of AI technologies. But the country needs to change its attitude towards innovation to succeed. Policymakers and industry representatives need to work together in a new way. The Italian government is showing a modern and strategic vision, and Farmindustria is committed to doing its part. For example, we recently produced a position paper that defined the required regulatory framework to make digital medicine a reality, with guaranteed free access to those technologies for all citizens. If Italy doesn’t ensure that current technologies, already in use in other countries, are integrated into our healthcare system, we will lose opportunities from future AI developments.

Italy’s infrastructure and access to technology is inequitable. Could AI increase the nation’s disparities?

The risk is real, but we could use these new technologies to mitigate. We live in a country with significant inequalities at the local level, and not just in the health sector. AI innovation cannot be stopped, and we do not want to fall behind the rest of the world, so government needs to avoid increasing our regional differences. The PNRR will seek to address these; starting with infrastructure, we need to fill the gaps the country has accumulated in the past few decades. The pharmaceutical industries aim to help. From Bolzano to Palermo, our country needs a strategic vision with common rules and no regional differences.

Does AI pose any risk to employment in the pharmaceutical industry?

We will need to develop new skills, but this is part of the normal flow of progress. The number of jobs will increase overall if investment in AI is also linked with investment in education, evolution of competencies and re-skilling of professionals. There is no need for magic spells; education, skills and investments are the only working ingredients. We have them in Italy and Europe: we only need to stir them. The Italian government has shown the will to recognize the value of the pharmaceutical industry for our country with concrete initiatives, we believe a similar path will be possible for AI.

Click here for more information on Farmindustria and how it is supporting innovations in Italy and Europe.

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