This article is written by Ms. Srikrishna Samhita Yadati a Second Year B.A.LL. B student of ILS Law College, Pune

Abstract

The interplay of IPR and the Ethics Committee is vital for the supervision of medical research and inventions emanating from it. While the protection of these groundbreaking discoveries is imperative for furthering research and development, certain ethical quandaries need consideration. This article examines the functions of the EC in safeguarding the sensitive information contained in clinical trials as well as the interests of all the stakeholders involved. The limitations of patent law in protecting comprehensive clinical trial data are explored, along with the ethical dilemmas associated with patenting, including high costs and potential obstacles to further research. Balancing innovation incentives with ethical conduct and accessibility is crucial to maximize medical advancements without compromising professional integrity or patient welfare.

Keywords: Intellectual Property Rights (IPR), Ethics Committee, medical research clinical trials, patent.

Introduction

The concept of Intellectual Property Rights pertains to protecting the creativity and innovation of the human mind and promoting the same with the hope of having new products, technology and machinery in the economy. A direct implication of this can be seen in the healthcare sector where patents are sanctioned for drugs, medicines, medical procedures, etc. Patents are essentially granted for an invention that satisfies the conditions of novelty, non-obviousness and industrial application. The same conditions are to be satiated in the medical area as well.

During medical inventions, all the medical professionals conduct clinical research or trials before bringing in a new drug or medication to the public. They are supposed to. This becomes one of the most essential processes since it involves the process of drug development. Now, while conducting these trials, there are some ethical standards to be followed by these researchers. They may range from treating the human subject with utmost care to taking precautions and protocols during the trials. In short, there are a lot of intricacies involved within these moral principles. 

This is where an independent body, called the Ethics Committee (EC) is constituted to oversee the adherence to these ethics. It is often strongly upheld that all the objectives of these committees pertain to the rights, fair treatment, benefits, etc. of the research subjects. However, what is equally significant here is protecting the undisclosed information or discovery that may stem from a clinical trial. For instance, if a medical professional tests a formula or a drug and documents it, then it must be protected or taken care of not getting it disclosed before it gets patented. As such, one can hardly cite the IPR goals of the EC, however, this is a perilous function that is to be discharged. It is important to understand the degree of legal protection these medical inventions might require for the security and welfare of the individuals who are indulged in them.

Securing Clinical Trial Data: Significance of Ethics Committees 

 The evolution of the ethical standards can be dated back to the Nuremberg Codes. These were formulated to establish ethical principles after the catastrophic Nuremberg Trials also known as the Doctor’s Trial during the Nazi era. This is one of the momentous and landmark legal documents which was made because they are claimed to be the first of their kind. However, critics argue that it has no legal force behind it and it is one of the poorly constructed frameworks.

Nonetheless, in today’s time, specialized committees called the Ethics Committee have come into place that supervise, review, reject, and analyse the conduct of clinical trials. Usually, these committees comprise scientific experts. The roles and functions of the EC are based on 6 fundamental principles:

• Autonomy: recognize the patient’s freedom to decide based on their values.
• Justice: handling research subjects fairly.
• Goodwill: act in the patient’s best interest.
• Nonmaleficence: not harm the patient first.
• Protection of confidential information
• Transparency: being truthful about the research

Keeping these rudiments, the EC performs its tasks like quality improvement and cost-benefit analysis, evaluation of procedures, setting out approval for each phase of clinical processes, etc. The most important function of the EC is the protection of confidential information which may eventually lead to medicinal discovery or innovation. The investigators and researchers, undertaking clinical trials, tend to document their observations and critical data and then analyse them to decide whether to go ahead with the research or not. As a result, there is a requirement on the part of the EC to prevent the disclosing of such information during and after the trials. The documentation of these crucial data and technical know-how has a great potential for commercial value, which if it all leaked, can be exploited by other competitors in the pharmaceutical market.

Patent and other IP Law Approaches

The stakeholders involved in the clinical research are the investigators who conduct the research, pharmaceutical companies who fund these trials and other medical procedures, human subjects and the public. All of them have certain interests and benefits but they might be dissenting. For instance, the pharmaceutical companies that sponsor clinical research have an economic interest due to which they desire to keep the trial data and information obscure for an extensive period. In contrast, the interests of the researchers are purely scientific. After extensive hours of pre-clinical and clinical phases, when researchers make a breakthrough by discovering a new chemical entity, there is often a desire to share the test results with the public. This is so because it can boost their professional careers. These differing interests ensue in conflictual situations. In such a predicament, it is very difficult to address each stakeholder’s interests and create a unified system of clinical trial data.

However, as per the conventional notion, some evidence and facts that are highly valuable have to be kept discreet for the sake of Intellectual Property Rights. In medical research, some data are to be safeguarded: chemical formulae, protocols for clinical studies, formulation files sent to prospective participants to enlarge their knowledge, data and statistics gathered during clinical trials, and final test results. These are the bare minimum amount of data and information that require legal protection. More or less, the facts and figures produced out of clinical trials are to be considered intellectual property since they are essentially the outcome of the human mind and creativity. The most apt and relevant way of legally protecting these records comes under patent law.

Patent Law

As discussed earlier, whenever some medicine or drug is developed through clinical procedures, the best way to protect it legally is to apply for a patent. Through the process of drug development, the manufacturing method and final results of the study are on an equal footing for patent protection, as guaranteed by the TRIPS Agreement. It also becomes essential to specify the subject matter to file for a patent application as they may range from the product to the manufacturing process. However, there is a catch here. During a clinical trial, the statistics and data collected, the protocols followed and the test results submitted to the concerned authorities are not patentable. This is because they do not satisfy the grounds of patentability, especially that of industrial use. An extension of this would be the inventions contained under section 3(d) of the Indian Patent Act, 1970 which states that the discovery of a new form of a known substance or new properties, uses, or processes for known substances cannot be patented unless they result in a significant improvement or involve at least one new reactant. This statement may seem to be very straightforward at first instance, however, there might be situations where even though the medicine developed may prove to be new and effective; the fact that it is just a new form of a known chemical defeats its patentability. 

Undisclosed Information

The often overlooked yet crucial aspect of IPR Protection. Trade secrets, also known as confidential information, encompass formulas, patterns, compilations, programs, devices, methods, techniques, and processes. While it’s perhaps the most significant form of protection for industries, R&D institutions, and IPR-related entities, it remains relatively unknown and under-discussed among IPR stakeholders. Under UI, there is a wide spectrum of data yielded out of clinical trials which can be safeguarded. According to the UI rules, there is no requirement for a specialised higher authority for its inadvertence as long it is kept a secret. Even when the information is submitted to the executive bodies for approval and seeking sanction of the right, it is still protected as per Article 39 of the TRIPS Agreement. During the process of approving the marketing of that pharmaceutical drug, the undisclosed results and information need to be protected from unmerited commercial purposes, unless of course, it is in the interest of the public. Unfortunately, there is no exclusive legislation governing the protection of undisclosed information or trade secrets in India. If this law would have existed then clinical data and statistics, medical procedures and personal data files of the subject would be protected under undisclosed information.

Copyright

It may seem that the copyright law may not be very useful in protecting the data and information arising out of a clinical trial, however, all the documented test results and published research papers submitted to the administrative authorities can come under copyright protection. However, since they have to be published to apply for copyright, it is not very beneficial in the clinical arena. The purpose is to protect the work during the process of clinical trials and before arriving at the final results and conducting scientific conferences which are essentially people-centric. In short, copyright will be proven to be unsuitable especially for medical research and trials unless the work is published. 

The Ethical Dilemmas Posed by Patents in Medical Processes

The patenting of clinical research has gained a lot of criticism from various commentators and critics. One of the major denigrations of the patented procedure is the skyrocketed cost it tags along. When a work is granted a patent, others who wish to utilize it for their purposes often face substantial costs to avoid infringing on someone else’s intellectual property. Of course, it is reasonable for the owner of a patent who has put humungous efforts to build his/her research. However, because of the high cost involved, it restricts the research community from undertaking further research and peer review by investigators and academicians. In olden times, medical professionals were supposed to have an open communication of whatever discovery they made in the medical field, notwithstanding any additional financial reward. This well-established principle is documented in the American Medical Association’s Code of Medical Ethics. Nevertheless, with the advent of IP Law, specifically patents, physicians, doctors, researchers, etc., have started using the patent facility for the protection of their work. This attracts certain ethical challenges. Firstly, the patent has one major negative connotation attached to it: obscuring renewed medical knowledge for personal gains. One might say that once a medical method gets patented then the owner of that procedure can make it available to the public at large by charging a licensing fee and it’s a win-win situation for both the people and the owner. However, some physicians and pharmaceutical companies charge very high prices for their patented works which makes it problematic for budding researchers to avail their work. This becomes an ethical challenge over personal gain. Secondly, clinicians who pursue and uphold patents can be responsible for the decline of professional conduct as the whole and soul of a medical professional is patient welfare. If we view it from the lens of ethics and morals, seeking out individual profits and ownership undermines the cohesiveness of the profession. There is no denying that patenting is a legitimate right given to everyone, but when a profession, especially a medical profession meddles with ethical principles, the latter outweighs the former. A final concern is about how the patents can be enforced. The sales of medical equipment can be monitored but it would be almost impossible to monitor the technique of how the physician has utilized the patented procedure. Adding to that, monitoring would again hamper the privacy of both physicians and patients. This poses an ethical dilemma. Up until now, bioethics has been sidelined within the field of patent law, where the main emphasis has typically been on how profitable patents are for promoting innovation rather than any potential moral ramifications for public health.

Conclusion

The intersection of Intellectual Property Rights and clinical research in the healthcare sector reflects a complex and ethically challenging landscape. While the protection of innovative medical discoveries is essential to incentivize research and development, it raises ethical dilemmas and considerations that cannot be overlooked. The role of the Ethics Committee is very crucial in protecting the critical information arising out of clinical tests along with safeguarding the interests of the subjects. However, the function should be widened to include overseeing the positives and negatives of patenting in terms of analysing substantial details resulting from clinical trials. To an extent, the protection of clinical trials is limited under patent law since it does not protect the protocols and test results of the medical process. Additionally, the patenting of clinical research has posed some condemnation from commentators whose main contention is regarding high costs and inaccessibility to medical procedures and techniques. Balancing the incentive for innovation with the need for ethical conduct, transparency, and accessibility is essential to ensure that the benefits of medical advancements are realized without compromising the integrity of the profession and the well-being of patients. The ethical implications of IPR in healthcare call for a comprehensive and thoughtful examination of the existing legal frameworks and their impact on research, innovation, and patient care.

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