Fostering Innovation and the Importance of Market Access
This year, we had a pleasure of being a key contributor to the just released 2021 Bioregion Report, the benchmark study that analyzes the life sciences and healthcare sector in Catalonia, conducted by Biocat, BioRegion of Catalonia together with CataloniaBio & HealthTech and ACCIÓ.
Following the release of the report, we spoke to Robert Fabregat, CEO of Biocat, and Chus Castillo, Director of Global Market Access at Alira Health, to understand how companies can foster innovation locally and globally, and the role market access plays in industry growth.
Robert, tell us about Biocat. What are its goals and mission?
Robert, Biocat: Biocat brings together the life sciences and healthcare innovation community in Catalonia, Spain. Biocat was created in 2006, at the behestt of the Government of Catalonia, and today, professionals from more than 1,300 companies and 90 research institutes make up our community. Our mission is to maximize the economic and social impact of the BioRegion, the life sciences and healthcare innovation ecosystem in Catalonia.
Our strategy focuses on three main areas:
- Raising awareness and promoting the BioRegion by creating tools and strategies for improving the Catalan healthcare sector and increasing its visibility at home and abroad, positioning the BioRegion as an international hub of innovation.
- Providing innovative training and development through programs and initiatives to improve talent and entrepreneurship—two essential factors for the overall growth of the sector.
- Accelerating technology transfer and business growth by supporting activities designed to increase the value of the sector, with emphasis on research, knowledge and technology transfer, internationalization, and access to capital.
How is Biocat an accelerator for new companies?
Robert, Biocat: As part of our focus on fostering entrepreneurship and collaborating on value-added programs that help turn projects into technology-based companies, we have two programs, d·HEALTH Barcelona and CRAASH Barcelona, that support the emergence of startups in biotechnology, medical technology, and digital health, as well as the acceleration of existing projects through incubation, training, mentoring, networking, and access to funding.
What are the main life sciences trends in Catalonia?
Robert, Biocat: After the experience of the pandemic, there are three sector-wide trends that will mark the future of the ecosystem in the post-COVID-19 era.
- Digitalization of the healthcare system: We’ve seen the potential of new technology, like artificial intelligence and telemedicine, that have made it possible to deliver healthcare services at a time when physical facilities saturated by COVID-19 patients caused other activities to be limited. Now we must incorporate these digital technologies into the healthcare provision to make sure they are widely accessible, which include working in the harmonization of European regulatory pathways.
- Environmental sustainability: We’ve seen the impact our sector has on climate change and now is the time to raise awareness and adopt measures to ensure we can meet the commitments laid out in the Paris Agreement and the European Green Deal, reaching zero emissions by 2050.
- Public Health: From the standpoint of promoting health and preventing disease, COVID-19 has opened our eyes to the need to focus more on the population’s well-being, healthy aging, and equity, by empowering people and fostering healthy environments.
When it comes to innovation, why do organizations like Biocat, authorities, and private companies like Alira Health need to work together?
Robert, Biocat: Biocat builds relationships with companies based on the type of project and its strategic goals. This year Alira Health was chosen as our partner in drafting the 2021 BioRegion Report for their knowledge of the healthcare sector, particularly the regulatory framework for health innovation in Europe and market access.
This year’s report, which was just presented on January 26, includes a chapter analyzing the process of taking pharmaceutical and medical technology products to market so they can reach the general population. And, in March, there will be a post on the Biocat blog analyzing aspects of this topic in greater depth.
Why is it so vital for companies to understand the importance of market access?
Chus, Alira Health: In every country, a drug must meet national regulatory approval, and then in some countries, like Italy or Spain, a drug must also meet regional regulatory approval to guarantee reimbursement. Generally, this process happens in two parts:
- Health technology assessment (HTA): This is a systematic evaluation of the properties and effects of a drug, comparing the treatment benefit against existing alternatives. In clinical trials, this may also be against a placebo
- Pricing and reimbursement negotiations (P&R): Different parameters are used to evaluate and set the price of a drug. These parameters vary among markets, as well as the type of drug (original, generic/hybrid, innovative, orphan)
Market access support during both HTA and P&R can be critical to understanding the different requirements of each country and securing both price setting and reimbursement.
What are the main market access trends around the world?
Chus, Alira Health: In the Pharma market, general trends are focused on Real World Evidence (RWE) and Big Data. Both will play an important role in the decision around pricing and reimbursement. There’s an overall exponential growth in the use of Big Data and analytics, and we’ll see more use of RWE as a prerequisite for P&R—and for the adaptation of contracts based on the results. Additionally, we’re seeing the transformation and digitization of the type of company bringing drugs and technologies to market.
In the Med Device market, technology is driving the future of the healthcare ecosystem, with greater adoption of Artificial Intelligence (AI) and Big Data in therapeutic decision making. We’re seeing more digital therapies in the marketplace as well as universal adoption of telemedicine. There is also increased market presence for precision medicine, precision surgery, and robotics. And the overall proliferation of the Internet of Medical Things (IoMT).
Where does Spain stand in terms of market access?
Robert, Biocat: For a long time, market access in Spain has been under soft guidelines. Since the mid-2000s, the regulation of drug prices and the tightening of rules between the government and the pharmaceutical industry have kept the impact of market access groups to a minimum.
Spain has a well-developed pharmaceutical market with many innovative therapies, but there are some peculiarities in terms of regional regulations.
For example, the Spanish government is the main payer, and the National Health Service supervises approval of new medicines through the Spanish Agency of Medicines and Medical Devices, while the Directorate General for Pharmacy and Healthcare Products makes decisions regarding pricing. Additionally, 17 autonomous communities also play an important role in launching a product to market, as each autonomous community establishes its own budget and reimbursement guidelines.
So even though a drug may be approved nationally, each autonomous community has the power to decide whether it is distributed in their region. This management at the regional level makes Spain a unique case.
Chus, Alira Health: Today’s market access challenges in Spain center around its new administrative entities, like Valtermed, that are being used to provide drug valuation, and how to incorporate health outcomes and their economic impact to the public health system. When it comes to market access for medical technologies, the challenge is how to adapt to the new European market access regulations on these technologies.
What does this mean for American and UK companies who want to enter the Catalonia region?
Chus, Alira Health: Understanding the complexities of regional markets requires in-depth local knowledge as well as coordination across disciplines—and this is where most companies need support. Our collaboration with Biocat leverages their expertise in the complexities of the Catalonia healthcare ecosystem to guide companies looking to enter the market with their drug or technology. Their regional insight combined with our global presence, allows us to deliver comprehensive market access support at all levels.
About 2021 Bioregion Report
2021 Bioregion Report is the benchmark study that analyzes the life sciences and healthcare sector in Catalonia, conducted by Biocat, BioRegion of Catalonia together with CataloniaBio & HealthTech and ACCIÓ.