Digital Pills, 3D printing of synthetic organs, and precision medicine are not only dramatically changing our quality of life, but our legal mindset too.
Author: Marta González, Legal Director Eversheds Sutherland
Technological advancement has invaded our lives, and over the last twenty years it has drastically changed the way we interact with one another, spend our free time, access information, and even work. New technologies are a reality that we have incorporated into our day-to-day lives with greater or lesser skill. Their rapid evolution never ceases to amaze us and challenge our ability to adapt.
If I had to summarize what all of this has meant for practical purposes, I could say that new technologies make our lives easier. But when we speak of the implications that technological advancements have had on certain sectors, such as the healthcare sector, the relevance of this progress is taken up a notch, as we are talking about saving human lives, or at least improving the living conditions of sick people, which is without a doubt the most precious asset. The pharmaceutical and healthcare tech industries are the most sophisticated in the world. Given that drugs are subject to extreme regulation, all professionals involved in the marketing chain are required not only to know all the regulation of the products at any given time, but also to be aware of all the potential consequences that may be caused by the integration of these new technologies into these products.
Recently, we have seen how the Electronic Health Records (EHR), digital imaging, e-prescriptions, digital pills, 3D printing of synthetic organs for implantation, nanotechnology, and precision medicine have broken into the health industry, often times causing controversy and raising legal questions that must be analyzed.
To that end, I will briefly touch upon a couple of the technologies mentioned above:
On November 13, 2017, the Food and Drug Administration approved the drug Abilify MyCite. This drug, designed for the treatment of schizophrenia, bipolar disorder, and depression in adults, incorporates a sensor that sends a signal to a mobile application, which then notifies the patient, their family members, or doctor that it has been ingested. Once ingested, the digital pill sends a message from the sensor to a patch that is placed on the patient’s body. This, in turn, transmits the information to a mobile application that records the intake of the medication. With the patient’s consent, their caregivers and doctors will be able to access the patient’s data and information via a website. This requires precautions to be taken regarding data protection, cybersecurity, and patient consent. In the first stage of the product approval process, the FDA rejected the approval of Abify MyCite. The FDA requested that the companies behind it, Otsuka and Proteus Digital Health, provide additional guarantees regarding the safety and effectiveness of the product. They required, among other things, for the app and web content to be simplified so they are easier to use, as well as ensuring patients can understand all the information (as some may suffer from cognitive impairments).
Is it possible to predict whether a specific person will suffer from pancreatic cancer, or Alzheimer’s? One of the biggest challenges facing medicine today is trying to predict or estimate the risk of disease in a healthy person. The tool that is shaping up to be the most powerful in terms of achieving this goal is precision medicine, which aims to adapt medical treatments to the individual characteristics of each patient. In order to do so, the analysis and identification of biomarkers—precise indicators of biological processes, such as DNA, protein sequences, mutations in the body or in the patient cells—is key. Such biomarkers provide accurate information on the medical condition of each individual patient, facilitating its prevention, diagnosis, and treatment.
The aforementioned has clear implications when it comes to the patentability of these substances. This debate has led to the adoption of various positions within the different jurisdictions. Legislation, both in Spain and its surrounding countries, are categorical on the fact that it is not possible to patent human genes, including the total or partial sequence of a gene. However, there is uncertainty on how to determine whether or not the following are patentable: the extraction of a person’s DNA, the isolation of a particular gene, the amplification and identification of a series of mutations in that gene, and the link between these mutations and a greater likelihood of that individual developing an illness. The European Union, and thus Spain, does not exclude the possibility of patenting an isolated element of the human body (including gene sequences for the purposes of precision medicine), when the technical procedures that have resulted in the identification, characterization, and multiplication of that element (isolated from or external to the human body) involve the use of techniques created and developed by humans that cannot arise spontaneously or naturally.
This is not the case in the US, where the criterion is that isolated (non-synthetic) genes cannot be patented.
As a general reflection on all of the above, my advice to the lawyer seeking to efficiently advise companies operating in the health sector, is to be equipped with the following: special knowledge on the topic, the ability to adapt to their environment, a constant desire to update their knowledge, and a willingness to take the necessary steps to successfully overcome any barriers and challenges, both regulatory and legal, that they may face involving technological advancement in real-life practice.
Marta González is Legal Director at the Life Science Department of the law firm Eversheds Sutherland. Her professional practice focuses on advising companies in the pharmaceutical sector as regards their main areas of activity, with an emphasis on representing them before the court on patent infringements, product liability, and unfair competition claims. In addition, Marta has supplemented her experience in the sector by working as an in-house lawyer in the legal departments of pharmaceutical companies such as GlaxoSmithKline, S.A. (Spain) and Celgene International Sarl (Switzerland)”.
Note: The views expressed by the author of this paper are completely personal and do not represent the position of any affiliated institution.