IÑAKI GUTIÉRREZ-IBARLUZEA, OSTEBA
Over the last two decades, many countries and regions around the world have invested in advancing innovation in the life sciences. What’s more, a good majority of them have been successful in increasing the number of initiatives and volume of research undertaken, as well as bolstering employment in this sector. Some have laid claim to being leaders in certain innovative areas, such as photonics. Nevertheless, most efforts have been failing to reach the real market in their nearby health care sectors. One example is the European endoscopic capsule, which failed to achieve good results even after being awarded several rounds of EU funding. Underlying all these failures is the complex level of interactions and perspectives within the health care sector itself.
By better understanding this complexity, innovators and researchers can increase their odds of making an impact on the quality of health care people receive. Two main translational gaps need to be overcome in order to achieve success in most health markets. The first is to achieve the regulatory accreditation necessary to obtain market access. In many cases, especially for medical devices, this depends on money and investment and not on evidence requirements.
Notwithstanding, it is important for innovators to consider that regulatory authorities establish different rules for different contexts. Furthermore, there appears to be a misguided understanding that once market authorization has been obtained, such as a CE mark or FDA approval, the work is done. It isn’t. What is compulsory in one situation may not be necessarily mandatory in another. Satisfying different requirements in different systems increases the costs of designing and carrying out trials and achieving compulsory outcomes. Focusing in the most suitable market for each solution would be the most productive strategy for innovators. In addition, health systems and governments also should make an effort to harmonize regulatory requirements, the first guarantee for patients and citizens.
Once regulatory approval has been achieved, the second translational gap involves securing the interest of reimbursement authorities. In many countries, there is a misalignment in what is required by regulatory and reimbursement bodies, which consequently escalates the costs and makes the process of bringing a technology into real health care unaffordable for most innovators, who typically are small or medium enterprises or spin-offs.
Current European initiatives — such as the Innovative Medicines Initiative (www.imi.europa.eu) or EUnetHTA Early Dialogues (http://eunethta.eu/outputs/eunethta-early-dialogue-consolidated-procedure) — address the misalignment of regulatory and reimbursement requirements. But they do not suffice, and further efforts must be made to standardize requirements for market access. Moreover, regulatory bodies and purchasing processes need to be more professional.
Health Technology Assessments as a support to decision-making processes should be broadly implemented by anyone that aims to be successful in market access. Such assessments consider all the criteria that influence decisions: clinical aspects as well as economic, legal, ethical, social and organizational issues. Furthermore, they are crucial to making transparent decisions based on multi-criteria dimension analysis. Instituting a clear-cut process of decision-making would enhance alliances between innovators and health systems and help foster evidence-based uptake of innovation at affordable costs.
In general, approval from regulators and reimbursement authorities does not grant an innovation’s automatic use in health care practices. Most new technologies are designed for diagnostics. Many of the new solutions offer incremental improvements in accuracy over competing devices or have the capacity to continuously monitor health parameters. But to prevail in the marketplace, a new technology needs to change the paradigm of health practice and, ultimately, health outcomes (whichever they are: patient-reported, quality of life, or morbidity and mortality).
That means anticipating care when necessary, personalizing management, or indicating different treatments. In many cases, incremental accuracy by a few tenths, or thousandths in some parameters, does not change the clinical decision around a treatment or its management. And, in many conditions, health professionals don’t have any idea of what the 24-hour monitoring of some clinical parameters seven days a week will mean. So these technologies will remain at the research level without broader implementation.
New technologies should be tailored to the context in which they ultimately may operate. This means that innovators need to analyze the characteristics of a health care system, including professional competences, the level of care in which patients are being treated and procurement schemes, as well as a technology’s potential acceptability by health professionals, patients and citizens.
The best solution for one country, region or even setting may not necessarily be the best solution for another. Furthermore, innovators and investors should be aware of other solutions in development relating to the pathologies they are targeting. This means not only looking at the work of competitors, but at entirely new treatments or patient-management solutions that could make their proposal unnecessary at the beginning or mid-term.
Meet the author
Iñaki Gutiérrez-Ibarluzea is the vice chair of EuroScan, an international network for the identification and evaluation of new and emerging health technologies, and knowledge manager of Osteba, the Basque Office for Health Technology Assessment, Ministry for Health, Basque Government.
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