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In healthcare, innovative policies and regulations are more effective than technological development in delivering benefit to the patient

 

DISPOSITIVI MEDICI

 

The actual invention, development and launch of an innovative product or technology effectively meeting a specific need, is not by itself a sufficient condition for a success, as strict rules, risk adversity and resistance to change are deterrents for the community to gain real benefit from innovation.

Barriers to entry are the main reason why many potentially highly innovative solutions remain at prototype level.

This fact is even more prevalent if the specific sector is highly regulated, and the health sector is an excellent example of a challenge to innovate within.

The health sector is possibly the most resistant to the introduction of innovation and at the same time, one of those that could benefit the most from innovation, in terms of both improving population conditions and economic sustainability for the government.

The health sector is characterised by established practices and strong resistance to change which is motivated by risk adversity, caution for patients, consolidated medical practices, regulatory approval, and the like.

The healthcare system has a vital need to introduce innovative management models, technologies and services as many of today’s consolidated practices are no longer economically viable, so change is necessary. Many innovative technological solutions are already available but are not able to be introduced because of the barriers mentioned previously.

So, innovation in policies, legislation, regulatory frameworks plays today a more important role than the technological development, as far as the delivery of effective solutions to the citizen and to the patient is concerned.

A way to increase the likelihood that innovation can overcome the entry barriers is to establish novel practices to allow the temporary testing of innovations in derogation of existing regulatory constraints to obtain data and information for any subsequent decision to introduce changes in practice and legislation.

There are several examples of fascinating medical innovations that from the technological development may be ready to be implemented, whose introduction can be accelerated by a change in policies, or by a temporary test in derogation to existing policies.

Some examples:

  • Personalised medicine: the ability to use a patients’ genetic information to predict the effectiveness of the drug to be prescribed, tailored to their specific genomic profile. This treatment program is more effective, but has an unavoidable consequence: it reduces the market for the drug producer, who has had to invest huge resources in product development and clinical trials but can only rely on a fraction of patients (those whose genetic profile makes responding to the drug). The current system of rules that regulates clinical research and related investments is a deterrent to the introduction and marketing of custom-based patient solutions.
  • Access to patient data is another pertinent example. Depersonalised patient data are the source that allows artificial intelligence algorithms to identify patterns important to improve medical practices with various benefits, such as lower risk of error, organisational benefits, and savings in hospital management. Surveys show that the public would be happy to make their own personal data available in depersonalised and aggregate form for research purposes. For their elaborations, the software requires just anonymous data, as many as possible. But in spite of it, in many jurisdictions there is a very prohibitive legislative system that makes it impossible to process digital patient data, as a way to protect patient privacy, even if what is actually required is the access to aggregate and depersonalised data, not linked to any private information about patients.
  • Another evidence is the emergence of lifestyle-related illnesses (NCDs, non-transmissible diseases), today far more frequent than those transmissible (caused by infections). Cardiovascular conditions, metabolic diseases (such as diabetes) and neurodegenerative diseases (Alzheimer’s disease, Parkinson’s) and certain cancers today are the main causes of hospitalisation. Their causes are attributed not to pathogens, but to the habits of the population, such as diet, lack of exercise, substance abuse, and stress. It is therefore clear that if the healthcare system will not target just acute problems but also prevention, there will be important benefits to the quality of life and the economic sustainability. But this is not easy because the whole system, starting with the training of doctors, is based on a ‘sick-care’ model rather than a ‘health-care’ reactive, not preventive service. A small investment in prevention may generate big savings and positive improvement of the quality of life. But the existing reactive model of healthcare systems is a deterrent unless some innovative preventative practice is tested in derogation to the rules.
  • The combination of population ageing and the emergence of non-communicable diseases causes a growing proportion of the population to be affected by chronic or multi-chronic problems, while the healthcare system and its hospital resources are calibrated to deal with acute problems. This is also a deterrent to the implementation of a widespread care system, necessary to alleviate daily discomforts typical of chronicity, moving the point of care from the technology intensive hospital to delocalised sites, like homes. In older person’s homes, a lower intensity but frequent care is what is needed and it may be delivered through telemedicine, wearables, tele-monitoring solutions at a fraction of the hospitalisation cost. The technology exists, but its implementation is challenging, and policies, practices and regulations are the challenges.
  • Even the way the procurement process in the hospitals and governments’ health departments is structured, through tenders open to competing suppliers, is a deterrent to innovation introduction. In fact, since by definition the tender is geared towards products already present on the market, the most innovative products may not yet be known to the procurement offices. Derogations to this process are usually difficult, as the laws protect competition and transparency, but may be very effective in introducing innovation in the healthcare system in a faster and wider way.

There are many other examples within the healthcare system that could benefit from innovation in policies, legislation and regulatory frameworks, as clearly the main obstacle to meeting a need is not the technological development of an innovative solution, but rather the strict rules of the system, its risk adversity and resistance to change.

Those Governments that will learn how to quickly test innovative methodologies, by temporarily derogating from the rules in force, are those that will have greater opportunities to evolve positively in the direction of a better sustainability and effectiveness in delivering health care to their citizens.