The world of medicine and pharmaceuticals has been enriched by remarkable scientific developments. However, the pharmaceutical industry is faced with two fundamental challenges: not only producing innovation, but also adhering to ethical principles and environmental responsibility.
The first responsibility is ensuring that ethical principles are upheld in high-cost drug research; the second, and increasingly important responsibility is transitioning to sustainability as part of the fight against the climate crisis.
In this context, the pharmaceutical industry must:
- Adapt to a low-carbon economy,
- Reduce its environmental footprint,
- Implement green transformation policies,
- Reduce pressure on natural resources,
- Prevent environmental pollution,
- Reduce waste at source, separate it, and
- Carry out recycling or disposal processes using environmentally friendly methods.
These requirements have now become an inevitable duty for the sector.
1. THE BASIS OF ETHICAL ISSUES: THE PRINCIPLE OF TRANSPARENCY
Today’s pharmaceutical industry is witnessing groundbreaking developments such as antibiotics, biological drugs, personalized 3D printing technologies, smart drugs, phagotherapy, reuse methods, and artificial intelligence-supported solutions. These innovations give rise to not only scientific and technological but also ethical and legal responsibilities.
These revolutionary products and processes raise significant ethical issues regarding the confidentiality and security of highly sensitive information such as patient data, drug formulas, and laboratory results. Ethical principles such as voluntary participation, informed consent, anonymity, transparency, disclosure of risk of harm, and fair sharing of results are of paramount importance in research processes. Failure to adhere to these principles not only leads to individual rights violations but also undermines the trust of scientists and investors in the process, thereby jeopardizing the sustainability of the industry.
In this context, the most critical ethical principle is transparency. The importance of this principle has been emphasized in two important decisions of the Court of Justice of the European Union:
- Case C-175/18 P (PTEC Therapeutics International Ltd v EMA)
- Case C-178/18 P (MSD Animal Health Innovation GmbH and Intervet International BV v EMA)
In both cases, pharmaceutical companies objected to the European Medicines Agency’s (EMA) transparency policies on the grounds that the publication of clinical trial results would reveal trade secrets. The EMA rejected these claims and released the documents to the public with only partial redactions.
The cases were first brought before the General Court and then appealed to the Court of Justice of the European Union. In its ruling dated January 22, 2020, the Court of Justice ruled that, in order to protect the commercial interests of the companies, the information requested to be kept confidential in the relevant documents must be specifically and precisely defined. Additionally, it explicitly stated that marketing authorization application files for medical products cannot be automatically deemed confidential and that the public has a right to access such information.
2. The Fundamental Problem of the Pharmaceutical Industry is to Achieve Green Transformation
While investing in R&D and striving to protect investors with ethical rules, the pharmaceutical industry must also prepare the ground for these investments to be permanent and sustainable by eliminating the consequences of the climate crisis. R&D and innovation, biotechnological products, drug safety, waste management, business ethics and transparency, employee satisfaction, occupational health and safety, access to drugs, pricing, gender equality, human rights, data security and privacy, water management, animal testing, and biodiversity should be considered common ground. The foundations of a sustainable industry can be laid in this way.
For the Green Transformation to take place
- Continuous investment in the research and development of new products.
- Maintaining drug prices at reasonable levels and ensuring access for all consumers.
- Adhering to ethical and sustainability principles in supply chain management.
- Selecting packaging materials that are recyclable and environmentally friendly and designing them in a sustainable manner.
- Providing regular training on workplace safety and health.
- Offering programs that support the physical and mental health of employees.
- Making innovation and technology investments with sustainability in mind.
- Investing in R&D efforts aimed at protecting biodiversity and combating climate change.
- Offering programs for health education, disease prevention, and support for people with access barriers.
- Making preparations for drug donations and rapid response in emergencies.
- Proper separation and classification of medical waste.
- The use of environmentally friendly technologies in the waste management process should be planned.
In conclusion, the development and production of a new drug requires a high investment and provides a significant number of jobs. “Investment in drugs” has become one of the key sectors of the economies of the countries providing the investment. Therefore, the protection of data on high-cost drugs is important. Legal certainty must be established under the umbrella of ethical rules, such as the protection of commercial interests, the presumption of confidentiality, and transparency. However, investments that are only partially protected by these principles must combat the consequences of the climate crisis and ensure sustainability.
In the pharmaceutical industry’s fight against the climate crisis and its implementation of green transformation policies, investments in pharmaceuticals will be efficient and successful to the extent that economic sustainability, employee well-being, social responsibility projects, waste management, education, and awareness are prioritized and implemented.
