health, biomedicine and bioengineering

 

The relationship between law and science is complex and ever-changing, prone to extremely swift transformations, but it is necessarily of interdisciplinary and transdisciplinary nature.

If, on the one hand, science must be regulated, on the other hand the law must properly understand science, without unreasonably hindering research.

For a science willing to be wisely governed, there must be a likewise wisely informed policy-making.

The dialogue between scientists, lawyers, ethicists and technologists is necessary and urgent, in order to be able to build a common moral sense, to which to correlate a law capable of outlining horizons of reference, justifying principles and values to be applied in different contexts within the framework of general legal categories.

Many scholars have defined the current geological era as anthropocene, because of the fact that human activity has produced and continues to produce critical effects on a global level, both positive and negative: “the earth environment, understood as a set of physical, chemical and biological features, in which life takes place and evolves, is strongly conditioned on a local and global scale by the effects of human action”.

Meaningful points of convergence around a number of basic principles and rules are needed to protect new legal entities that, in addition to humans, have imposed themselves before moral scrutiny: non-human animals, nature and the ecosystem, future generations, nonetheless without placing rigid preventive constraints on freedom of research and science.

BIOETHICS AND BIOLAW

Bioethics and Biolaw have been brought (back) to the spotlight of public attention on a variety of issues related to Life Sciences, among which the most recent developments in the biomedical sciences and “frontier research” are undeniably of paramount relevance.

The questions raised by the progress of biomedicine, especially by the ongoing evolution of knowledge and applications of converging technologies Nano-Bio-Info-Cogno –NBIC– are multifaceted and have a major impact on the development of the legal sciences, acting as a legal fertilizer.

The central feature of emerging technologies is the progressive narrowing of the boundary between biological sciences -studying living beings- and physical sciences -studying non-living systems- in a dual orientation, across opposite but crossed directions: “from biology to technology” ( enhancement of living organisms) and “from technology to biology” (development of bio-inspired artifacts, biomimicry).

In the context of the first pathway, we are witnessing the progressive technological transformation of parts of the body and mind, namely the bio-engineering of complex living systems (genes, cells, tissues, organs, brain) into non-living systems (electrical circuits): from the design of neural networks of silicon, connected to biological neurons (neurocomputers), to wearable sensors and computers (wearables), including the installation of microchips inside the body and the cerebral cortex. (implantables).

The opposite but synergistic path “from technology to biology” sees the connection between biology and neurocognitive processes, through ICT computer science: the biologisation of inanimate entities, through the creation of machines resembling living organisms, i.e. capable of self-assembling, self-repairing, reproducing, thinking and adopting intelligent behaviours.

Biomimicry therefore studies the biological processes of nature to improve technologies.

FROM BIOLAW TO BIO&TECHNO LAW

As a result, this new technological wave marks the transition from bio-law to bio&techno-law, where the reference to the “bios” sphere is increasingly blurred, as biomedicine (biology and medicine) interacts with other traditionally separate scientific-technological fields.

Biolaw, or rather SciTech Law, is an autonomous inter/transdisciplinary legal discipline, understood as the set of legal issues related to Life Sciences and New Technologies, whose field of application includes human and non-human living beings, the environment and future generations.

Life sciences, notably biotechnology and bioengineering, have brought extraordinary benefits to a large part of the world’s population, after having been one of the incremental factors in the global rise in life expectancy, today’s goals are increasingly refined and ambitious, however they pave the way for a plethora of extremely sensitive and controversial issues.

By way of example, one may consider the issues concerning the beginning of life and the end of life, experimentation, scientific research and bioengineering.

The topics and fields of research are of overwhelming scope and range from the definition of an embryo and its patentability, to cognitive enhancement, from personalised medicine and genetic diagnosis techniques, to issues that revolve around the properties of tissues, biological samples and biobanks, passing through genome editing and neuroscience.

But it is necessary to underline the primary role played by the application domains of bio-engineering: from medical devices to neuro-engineering, passing through regenerative medicine and tissue engineering.

From issues that revolve around the relationship doctor-patient including informed consent, the right to be cured and distribution of health resources, to those focused on experimentation, from pharmacology to compassionate care, the role of a biolawyer (or lawyer in bioethics) is not only formal, procedural or factual.

 

THE ROLE OF A SCI-TECH LAWYER, BIOLAW EXPERT IN BUSINESS

 A bio-lawyer does not limit his work to safeguarding individual autonomy, assessing social profits, translating the legislative intention, verifying the fairness of procedures, distinguishing contexts by analogy or recording widespread social practice.

The expert in biolaw and technolaw must critically examine the content of the law, expressing a judgement of truth on the existing law: he is called to take a position against it and about its conformity to natural law, whether it concerns the “traditional” problems of bioethics and biolaw (beginning & end-of-life, healthcare and experimentation), or for the new “frontier issues”: genomics, neurosciences and neurotechnologies, new medicine, biometrics, big data, mobile health, enhancement, robotics, synthetic biology, nanotechnologies, cleantech and sustainable development, and so forth.

When providing assistance to public and private companies involved in medical, biological and biotechnological research, the lawyer dealing with biolaw and life sciences, often has to deal with regulatory gaps and therefore must identify the advisability of rethinking traditional legal concepts, which are sometimes inadequate in light of the new reality.

It is necessary to play an active role in outlining paths for positive regulatory translation, verifying each time the balance of interests at stake, and verifying whether a permissive or prohibitive approach that opens up opportunities and at the same time sets the limits of lawfulness of a technology -based on specific contexts- is indispensable or not.

 

THE BIOJURIDICAL AND BIOETHICAL DEBATE

It is now necessary to overcome the obscurantism, inspired by the anti-technoscientific catastrophism of technophobic and bioconservative bio-pessimists, who absolutize fears and alarmism in the belief that everything coming from technoscience is bad.

But we must also move away from the technological scientism of bio-optimistic and bio-progressive technophiles, who excitedly absolutize hopes to the limits of utopia, in the firm belief that everything that comes from technoscience is good.

Today we are faced with new scenarios unfolding with converging technologies NBIC, raising questions over the limits of technological and scientific progress risk-tolerance, but the need to address the risk is connected to the very human condition.

It is necessary to develop a non-dualistic ethical and juridical approach (lawful/outlawish, permitted/banned), but a critical and considered one that, on the basis available datasets, places the individual in the conditions of making a responsible personal choice (with respect to himself and others) and that enables society to participate in collective choices.

An uninterrupted, flexible and reviewable critical reflection is needed.

In the bio-juridical debate, there are several horizontal and shared principles:

The dignity of the human being: intended as the principle of protection of the physical integrity of the body and its parts (cells and tissues), safety, non-arbitrary manipulation, non-instrumentalisation and marketability of the body, physical and psychological inviolability.

The principle of vulnerability: a particular attention towards people in conditions of fragility and incapacity, such as minors, disabled people, pregnant women, prisoners, migrants, the poor, as well as people linked to developing countries.

Autonomy and responsibility: respect for a person’s ability to make personal choices in relational matters; autonomy always postulates information.

Proportionality: balancing of risks and benefits, aimed at maximising objective benefits and simultaneously minimising physical, psychological and social damages, either probable, potential or possible.

Justice: a principle based on equality and equity in the distribution of scarce resources, in the access to treatments and to scientific or technological results/applications.

Another matter related to the physician-patient relationship, addressed by P&S Legal in both its professional and scientific fields, medical responsibility (medical malpractice) has become an entirely reshaped field from a legal point of view.

An inversion of the old practice which favoured the responsibility of medical personnel and neglected healthcare organizations business risk has been witnessed.

 

MEDICAL RESPONSIBILITY

The Gelli-Bianco Law (Law no. 24, 8 March 2017), in conjunction with the evolution of the Italian jurisprudence case-law, has strengthened the responsibilities of healthcare organisations and has granted partial immunity to structured healthcare personnel.

In this way, diagnostic and therapeutic serenity has been ensured, containing excessive reliance on defensive medicine approaches and the associated public health costs.

The new regulatory framework therefore consolidates an adequate risk management approach, thanks to a thorough cost-benefit analysis, thus ensuring a fairer allocation of liability costs, without compromising any effective protection for patients.

Nevertheless, some sort of “sovereignty” has been created with regard to guidelines and accredited best clinical practices (whose compliance grants some liability restrictions to healthcare professionals), which qualify as soft law, non-typical sources of law, that traditionally impose on the recipient non-binding legal obligations (so-called soft obligations).

Such instruments have a de facto imperative influencing effect on health policies and are detrimental for innovative medical practices: “frontier research” areas indeed lack (more often than not) scientific codified parameters, or in the best case scenario they are based on obsolete practices.

 

WHY CONTACT P&S LEGAL

P&S boasts a unique expertise in global assistance in the Life Science arena, especially targeting companies engaged in medtech, biomedical and biotechnological industries.

Drawing extensively from our experience in assisting companies and research institutions in the healthcare, biotech and biomedical segments, both for private and public companies, we can provide an interdisciplinary service that allows us to support them in all areas of their activities.

The range of services ranges from support in the field of extraordinary operations to all the legal aspects related to ordinary business affairs, especially in terms of compliance and regulation, from research and development to the marketing of medical devices, food & beverages, cosmetics and drugs.

Starting from the handling of relationships with the regulatory authorities, up to tender-related litigation, going through corporate and trade matters, the choice of the law firm must necessarily be addressed to highly qualified operators, not only in technical and legal terms, but also with in-depth knowledge of the state of the art in science and technology, the relevant marketplace and the social & environmental impacts of the business.

Contact us to arrange an introductory meeting.