“I can do no other than the reverent before everything that is called life. I can do no other than compassion for all that is called life. That is the beginning and foundation of all ethics”

- Albert Schweitzer

Ethics are the abstract notions that drive one’s thought process beyond the limited precincts of the law to the vigil of one’s own conscience. Ethics gain a high significance when it comes to life sciences. As a result ethics in the pharmaceutical industry too have a global prominence. In the context of pharmaceuticals, ethics apply in all areas such as research and development, manufacturing, pre-clinical and clinical research, product promotion etc. Briefly, I would like to outline the ethical considerations in each of these sub-domains.

Pre-Clinical Research

In-vitro pre-clinical research involves studies in cell lines and other such biologically active media. Ethical practices here should be intensive from the viewpoint of environmental protection and biological safety in terms of having enough control that potential pathogens are not released from the controlled environments of the labs to the uncontrolled environment outside. Controlled mutations in such studies have the potential to accidentally generate pathogens. All such potential hazards must be given due consideration in the planning of such labs and designing and execution of such studies. While the existing laws do enforce some control, a self driven ethical mind set would be real control in such studies, because of the limited range in which law can verbalize the plethora of possibilities here.

In-vivo pre-clinical studies are the ones that are carried out on animals. Such studies have been subject to raging debates since the middle of the 20th century. Pharmaceutical innovators have reasoned to sufficient lengths that this is a necessity which must be undertaken to curtail the potential risks associated with the introduction of such novel entities in humans for the first time. While pre-clinical research is permitted, ethics must prevail to ensure that the permission to conduct research in animals is not used indiscriminately. All studies must have a sound rationale and specific endpoints. All protocols must be critically reviewed by a neutral ethics control group. The number of animals to be used in each study must be scientifically reasoned and kept to a minimum. The conditions the animals will be subjected to must be ethically evaluated and the potential pain and damage must be minimized to as low a level as reasonably possible. The findings of such studies too should be critically evaluated by the ethics committee to ensure that the study was conducted for and concluded to a good reason. Emphasis must be placed on a public reporting of such findings to ensure that there is no duplication of effort leading to unnecessary subjugation of animals in repetitive studies elsewhere.

Clinical Research

The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers and thus gives rise to ethical concerns. Informed consent of the subject, assent of the relatives in applicable cases, rational definition of the inclusion/exclusion criterion and ethical adherence to those, make the crux of the ethical review of clinical programmes. Double blinding and randomization of patients are important aspects that keep the clinical trial fair and neutral to all participants. The compensation and indemnity granted to the participants carries important ethical significance. Review boards and ethical committees instituted to control and approve protocols for clinical trial must be of a neutral composition and should ensure that participants are not exposed to undue risks in the study. The government plays a pivotal role here in terms of having legislation and enforcement that protects its population from unethical clinical research but at the same time doesn’t inhibit innovation for the greater good of human kind.

Manufacturing and Distribution

While most countries have a legal framework governing registration, manufacture, trading and distribution of medicinal products and while that framework is very well enforced in a pharmaceutical company by teams such as quality assurance and regulatory compliance, it is the ethical mind set of the everyday worker that may make smaller and sometimes larger differences to the end patient. Policies devised by experts may exercise control over how drugs are produced and released, but companies must strive to build a mind set in all workers where that encourages the worker to think of the potential hazards that an end user may face for a lapse that may seem innocuous to a naïve observer. Factory personnel must be encouraged to discuss with their seniors, whenever in doubt, about any potential concern they might have about a batch or a product. Encouragement of such attitude is likely to harbor better compliance than formal policies.

Marketing & Promotion

The ethical promotion of prescription medicines is vital to the pharmaceutical industry’s mission of helping patients by discovering, developing and promoting new medicines. Ethical promotion helps to ensure that healthcare professionals globally have access to information they need, that patients have access to the medicines they need and that medicines are prescribed and used in a manner that provides the maximum healthcare benefit to patients. Any promotional activity that influences a prescription without a justified necessity is considered unethical. All promotional material must be legitimate and backed by sound scientific justification. Promotion for any attribute that is not substantiated clinically or is misleading in any way is considered unethical. Ethics must prevail in any promotional tactics being used by a pharma company for healthcare professionals, for it may lead to prescription practices that may not be in the best interest of patients.

The prices at which drugs are sold have been a cause for a compelling debate calling into question the ethics of pharma companies. Prices must strike a balance between maintaining the commercial viability for the company and the affordability for the public in general. Companies must have special sensitivity in terms of pricing for underdeveloped countries, so that the healthcare needs of the needy patients are not hurt.

Epilogue

While current researchers would agree to my thoughts outlined above, I am hopeful that the above outline provides a holistic perspective to the future healthcare professionals reading it. It is evident that every step in the pharma value chain is fraught with ethical challenges which must be met in a righteous way. I would implore future pharmacists and researchers to take cognizance of such ethical dilemmas they are likely to face in the future and imbibe in them the mindset that helps them to address these concerns in the most humane way possible

Mukund Ranade

President & Executive Director

Emcure Pharmaceuticals Limited

Tags: MET Institute of Pharmacy