LEGAL ASPECTS OF CORPORATE GOVERNANCE IN PHARMACEUTICAL INDUSTRY

This article is written by Shayaree Sen of 4^th Semester of Jogesh Chandra Chaudhuri Law College, an intern under Legal Vidhiya

ABSTRACT

This article explores the legal aspects of corporate governance in the pharmaceutical industry. It begins with an introduction to the significance of governance in ensuring ethical conduct and public trust. The regulatory landscape is examined, including an overview of pharmaceutical regulations and the roles of key regulatory bodies. The impact of regulations on corporate governance practices is analyzed, emphasizing the importance of compliance and accountability. Corporate governance structures and the interplay between legal and ethical considerations are discussed. Emerging issues and challenges are identified, with case studies examining both successful governance models and failures, such as the Purdue Pharma Opioid Crisis and Valeant Pharmaceuticals International. The article also provides an overview of India’s governance scenario. By understanding these dynamics, stakeholders can better navigate the complexities of corporate governance in the pharmaceutical sector to promote integrity and safeguard public health.

KEYWORDS

Pharmaceutical industry, Corporate Governance, Accountability, Transparency, Public health, Medical devices, Drug Safety, Intellectual property

INTRODUCTION

Corporate governance refers to the way in which companies are governed and to what purpose. It identifies who has power and accountability and who makes decisions.[1] Corporate governance is the system of rules, practices and processes by which a company is directed and controlled. It ensures that the interests of various stakeholders, including shareholders, management, customers, suppliers, financiers, government, and the community, are balanced and protected. Effective corporate governance is crucial for maintaining investor confidence, attracting investment, mitigating risk, and fostering long-term sustainable growth. It promotes transparency, accountability, ethical behaviour, and compliance with laws and regulations, ultimately contributing to the overall success and stability of the company.[2] Corporate governance can indirectly impact public health through various channels. Strong governance policies, for example, increase a company’s likelihood of prioritizing the health and safety of its employees, enforcing environmental standards, and so on—all of which can lead to a healthier community. On the other hand, bad governance, which includes insufficient oversight or unethical behaviour, can result in negative consequences including contamination of the environment, hazardous working conditions, or the promotion of unhealthy products.

Because it directly affects public health, corporate governance is crucial in the pharmaceutical sector. The goods produced by this industry have a direct impact on people’s health, hence moral behaviour and legal compliance are essential. Tight governance makes sure that drug corporations follow strict safety guidelines, keep clinical trial results transparent, and put the needs of patients before their own bottom line. Because of the possible repercussions of product malfunctions or unethical behaviour, regulations are closely monitored. Companies may manage complicated requirements, reduce risks, and maintain integrity with the aid of efficient governance systems. Ethical factors, like equitable pricing, medication accessibility, and conscientious marketing, are essential to preserving stakeholder trust and protecting public health. Strong corporate governance essentially acts as a safety net in the pharmaceutical sector, ensuring that businesses put safety, ethics, and legal compliance ahead of innovation and profit.[3]

REGULATORY LANDSCAPE

While pharmaceutical laws differ greatly from nation to nation, they all typically work to guarantee the efficacy, safety, and quality of medications. Processes for approving drugs, manufacturing standards, labelling specifications, and post-market surveillance are usually important elements. Setting and upholding these standards is mostly the responsibility of regulatory organizations such as the WHO globally, the EMA in the European Union, and the FDA in the United States.

Key Regulatory Bodies

• Food and Drug Administration (FDA)  

The FDA is an American government agency that oversees the production, labelling, marketing, and approval of pharmaceuticals, medical devices, biologics, and food items. It guarantees compliance with safety, efficacy, and quality criteria.[4]

• European Medicines Agency (EMA)

EMA is in charge of approving, evaluating, and monitoring medications in the member states of the European Union (EU). In order to guarantee uniform standards throughout the EU, it collaborates with national regulatory bodies.[5]

• World Health Organization (WHO)

The WHO establishes international standards for drugs, including requirements for quality assurance, manufacturing procedures, and drug safety. Additionally, it offers nations technical support to improve their regulatory frameworks.[6]

• Pharmaceuticals and Medical Devices Agency (PMDA)

PMDA assesses and certifies medications and medical equipment for the Japanese market. It guarantees adherence to regulatory criteria set forth by Japan.[7]

• Health Canada

In Canada, medical devices, drugs, and other health items are governed by Health Canada. It evaluates products’ quality, safety, and efficacy and keeps an eye on their safety after being put on the market.[8]

• China Food and Drug Administration (CFDA)

This agency oversees the country’s laws pertaining to cosmetics, pharmaceuticals, and medical equipment. It is in charge of manufacturing procedures, market monitoring, and product registration.[9]

These regulatory agencies are essential in protecting the public’s health since they guarantee the efficacy, safety, and quality of pharmaceutical products.

Impact on Corporate Governance Practices

Rules pertaining to pharmaceuticals have a significant influence on corporate governance in the sector. These laws, which are intended to guarantee the efficacy, safety, and quality of pharmaceutical products, frequently place strict limitations on businesses engaged in activities including product development, production, marketing, and distribution. Pharmaceutical regulations require strong compliance processes from a corporate governance standpoint to guarantee adherence to legal and ethical requirements. To ensure compliance with regulatory obligations, businesses need to designate compliance officers, put in place efficient oversight mechanisms, and create clear policies and processes. Furthermore, financial reporting and disclosure processes are frequently required to be transparent and accountable under pharmaceutical rules. Businesses must notify shareholders, the public, and regulatory bodies in a timely and accurate manner on their financial performance, product safety, and regulatory compliance. Pharmaceutical legislation may also have an impact on the corporate governance frameworks and decision-making procedures of pharmaceutical enterprises. In addition to managing complicated regulatory environments, boards of directors and executive management teams must also strategically decide on product development and commercialization while minimizing legal and reputational risks. Moreover, stakeholder involvement strategies and shareholder rights may be impacted by pharmaceutical rules. Investors can evaluate risk and make well-informed investment decisions by carefully examining a company’s governance procedures and compliance records. In order to maintain openness, responsibility, and responsiveness to public demands and expectations, pharmaceutical corporations are also expected to interact with a wide range of stakeholders, such as patients, healthcare providers, advocacy organizations, and regulatory bodies. Overall, laws pertaining to pharmaceuticals have a significant influence on corporate governance practices in the sector. These regulations push businesses to implement strong compliance systems, improve accountability and transparency, and interact with stakeholders in order to respect moral principles and foster public confidence.[10]

CORPORATE GOVERNANCE STRUCTURE

The board of directors, senior management, and shareholders make up the three basic parts of a corporate governance structure.

Board of Directors

This group is in charge of managing the overall strategy and direction of the business. It is made up of a number of duly elected people who act as the shareholders’ representatives and make sure the business is operated in their best interests. The board approves significant decisions, selects and assesses the CEO, establishes business rules, and keeps an eye on managerial effectiveness.

Executive Management

This group consists of the CEO and other senior executives who oversee day-to-day business operations and carry out board directions. They oversee resource management, create and implement strategies, and make sure the business runs smoothly.

Shareholders

Owners of the company, shareholders have particular rights and obligations, including the ability to vote on important matters, choose board members, and receive dividends. They use tools like annual meetings and proxy voting to hold the board and management responsible for their decisions and actions.

By establishing a framework for decision-making, accountability, and supervision inside the organization, this structure makes sure that power is allocated fairly and that the interests of all stakeholders are taken into account.[11]

LEGAL AND ETHICAL CONSIDERATIONS

Compliance and Ethics Programs

Programs for compliance and ethics are essential foundations for ensuring that laws and morals are followed inside company structures. These courses outline detailed policies to guarantee that staff members understand and follow relevant laws, rules, and moral obligations in their work. In this framework, codes of conduct play a crucial role in clarifying the anticipated standards of behaviour and reducing the likelihood of misconduct, fraud, and conflicts of interest. These standards create a normative framework by highlighting the values of honesty, openness, and respect for one another as the cornerstones of the corporate culture.[12]

Anti-bribery rules, which are essential elements of compliance frameworks intended to reduce the risks associated with corrupt acts, are equally important. These rules establish strict guidelines for dealing with situations where bribery and corruption are likely to occur, emphasizing a zero-tolerance approach and putting strong reporting systems in place.[13]

Essentially, compliance and ethics programs foster an environment of responsibility and integrity within organizational ecosystems, which is a symbol of a steadfast commitment to moral business conduct. Enterprises can strengthen their long-term survival and success by protecting themselves from regulatory penalties, lawsuits, and reputational damage by strictly following to legal and ethical obligations. They also build stakeholder confidence.

Intellectual Property Protection

Utilizing particular laws and legal procedures is necessary to preserve intellectual property rights, such as patents and trade secrets. Businesses seeking patents must successfully traverse the complex process of patent prosecution, making sure their innovations satisfy the requirements outlined by patent laws for patentability. This covers utility, novelty, and non-obviousness. Furthermore, enforcing patents frequently necessitates litigation, in which defence attorneys must prove infringement and pursue damages and injunctions as remedies. Contrarily, trade secrets are protected by statutes and contracts. Important elements include putting in place safeguards to preserve confidentiality and creating strong confidentiality agreements. Trade secret laws provide for the pursuit of legal action to collect damages and injunctive relief in cases of misappropriation. Intellectual property regulations have far-reaching effects on business governance. Due diligence in mergers and acquisitions to evaluate IP risks and opportunities is one aspect of the meticulous management of IP assets that is necessary for compliance. Furthermore, in order to reduce legal risk and preserve moral principles, corporate governance frameworks need to incorporate intellectual property issues. Following IP rules guarantees legal compliance, builds stakeholder trust, and improves a company’s ability to compete in the market.[14]

Product Liability and Risk Management

Pharmaceutical companies have a lot of moral and legal responsibility to make sure that their medications are safe, high-quality, and low-risk.

• Product Safety

Firstly, pharmaceutical businesses have to follow strict regulations imposed by health authorities such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA). In order to prove the safety and effectiveness of their products before they can be sold, this entails carrying out lengthy clinical trials. Additionally, businesses must keep an eye out for any negative consequences of their products after they are on the market and respond appropriately if there are any safety issues.

• Quality Assurance

To guarantee the consistency and calibre of their products, pharmaceutical companies need to uphold strict production standards. This entails putting strong quality control procedures in place at every stage of the production process, from obtaining raw materials to packaging and delivery. Any departure from these guidelines runs the risk of endangering patient safety and putting the business in legal hot water.

• Product Liability Lawsuits

Pharmaceutical businesses must show that they carried out their duty of care to ensure the safety and quality of their products in order to defend themselves against product liability lawsuits. This necessitates adhering to all pertinent rules and regulations and thoroughly documenting the testing, production, and monitoring procedures. Additionally, businesses might have to show proof of their attempts to reduce risks and appropriately address any safety issues that surfaced after the product went on sale.

In general, pharmaceutical businesses must navigate a challenging set of moral and legal requirements in order to protect the public’s health and guarantee the quality of their goods. Adherence to these responsibilities serves to safeguard customers and uphold confidence in the pharmaceutical sector on the whole.[15]

EMERGING ISSUES AND CHALLENGES

Data Privacy and Security

In the digital age, there are many different issues in maintaining patient privacy and data security. Firstly, the sheer amount of data created and kept in digital form raises the possibility of security lapses. Encryption, access controls, and frequent security audits are just a few of the strong cybersecurity measures that healthcare firms need to engage in. Secondly, as technology develops, new vulnerabilities arise from things like cloud storage and Internet of Things devices. It takes constant attention to detail and flexibility in response to new threats to ensure the security of these systems. Thirdly, maintaining compliance with data privacy laws requires careful comprehension and adherence to intricate legislation, such as GDPR[16] in the European Union and HIPAA[17] in the United States. This entails guaranteeing consent, openness, and the right to deletion in addition to preventing unwanted access to data. The difficulty of data protection and privacy management is further compounded by the interconnectedness of healthcare systems, which involve data transmitted between providers, insurers, and third-party vendors. Standardized procedures and cooperative efforts are necessary to ensure safe data sharing while upholding compliance. To protect patient information in an increasingly digital healthcare environment, tackling these issues calls for an all-encompassing strategy that incorporates technology advancements, legal compliance, employee education, and continuous risk assessment.[18]

Cybersecurity Threats

Because pharmaceutical systems rely on interconnected networks for distribution, production, and research, they are vulnerable to cyberattacks. These vulnerabilities include ransomware attacks that interrupt production operations, data breaches that compromise key research findings or patient information, and tampering with medicine formulae or distribution networks that could endanger patients. Concerns regarding the security of linked equipment are also raised by the growing integration of Internet of Things (IoT) devices in pharmaceutical facilities, which increases the attack surface. Strong cybersecurity defences, recurring evaluations, and personnel education are essential for reducing these threats and guaranteeing the integrity and security of pharmaceutical systems.[19]

Pharmaceutical firms should put strong cybersecurity measures in place to manage cyber risks efficiently. These methods include:

1. Comprehensive Risk Assessment: Identify and rank any dangers and weak points.
2. Secure Network Infrastructure: To safeguard confidential information, use firewalls, encryption, and access controls.
3. Employee Training: Educate staff on cybersecurity best practices to prevent human error.
4. Incident Response Plan: Establish a precise procedure for identifying, handling, and recovering from cyber incidents.
5. Collaboration: Work with industry peers and government agencies to share threat intelligence and best practices.[20]

Pharmaceutical firms may protect their operations, data, and reputation by proactively mitigating cyber risks.

CASE STUDIES AND BEST PRACTICES

Successful Corporate Governance Models

One successful corporate governance model in the pharmaceutical industry is Johnson & Johnson (J&J)[21]. Their governance structure emphasizes transparency, accountability, and ethical practices. J&J has a board of directors with diverse expertise and experience, ensuring effective oversight. They also have strong mechanisms for risk management and compliance with regulations, fostering trust among stakeholders.[22]

Another example is Pfizer. Pfizer’s governance model focuses on promoting innovation while maintaining rigorous compliance standards. They have a robust system for evaluating and mitigating risks, allowing them to adapt to changing market dynamics while safeguarding their reputation.[23]

Best practices in pharmaceutical corporate governance include:

1. Transparent disclosure of financial and operational information.
2. Independent board oversight with diverse skill sets.
3. Ethical leadership promoting integrity and accountability.
4. Effective risk management strategies to navigate regulatory challenges.
5. Regular evaluation and adaptation of governance policies to align with industry best practices and evolving regulatory requirements.

Overall, successful pharmaceutical corporate governance models prioritize integrity, transparency, and adaptability to effectively navigate the complexities of the industry while maintaining stakeholder trust.

Lessons Learned From Regulatory Violations

• Purdue Pharma Opioid Crisis

Issue:- Purdue Pharma aggressively marketed OxyContin while downplaying its addictive nature, contributing to widespread opioid addiction and overdoses. The company misled healthcare providers and the public about the drug’s risks, leading to a public health crisis.

Lesson Learned:- The Purdue Pharma case underscores the critical importance of transparency and accountability in pharmaceutical marketing. Tighter regulations are needed to prevent deceptive marketing practices and ensure that companies prioritize patient safety over profits. Additionally, the case highlights the necessity of fostering a culture of compliance within organizations, where adherence to regulations and ethical standards is non-negotiable.[24]

• Valeant Pharmaceuticals International

Issue:- Valeant Pharmaceuticals International faced scrutiny for its aggressive drug pricing practices, acquiring older medications and drastically increasing their prices. The company also faced allegations of accounting irregularities and improper relationships with specialty pharmacies, leading to a loss of investor confidence and regulatory investigations.

Lesson Learned:- The Valeant Pharmaceuticals case highlights the dangers of prioritizing short-term profits over ethical considerations and long-term sustainability. Pharmaceutical companies must adhere to ethical pricing practices to ensure access to affordable medications for patients. Additionally, transparent financial reporting and proper oversight are essential to maintain investor trust and regulatory compliance. This case emphasizes the importance of maintaining integrity and ethical standards in all aspects of pharmaceutical operations to avoid reputational damage and legal repercussions.[25]

Other examples such as the Theranos scandal[26] and the Mylan EpiPen pricing controversy[27] further reinforce the crucial lessons learned from these cases. Overall, the pharmaceutical industry must prioritize ethical conduct, transparency, and compliance with regulations to uphold public trust and ensure the well-being of patients.

INDIA’S SCENARIO

The pharmaceutical sector in India functions under a legal framework that is regulated by numerous statutes and regulations that are designed to maintain corporate governance and compliance. The Companies Act, 2013[28] is a key piece of legislation that addresses the appointment of independent directors, the obligations of directors, and the preservation of financial reporting transparency. In order to protect shareholder interests and preserve market integrity, the Securities and Exchange Board of India (SEBI)[29] regulations also require disclosure standards, such as those pertaining to related-party transactions and insider trading.

Moreover, the Drugs and Cosmetics Act, 1940 and the Drug Price Control Order (DPCO), which regulate drug manufacture, marketing, pricing, and quality control, impose particular rules on the pharmaceutical industry. Pharmaceutical firms must abide by intellectual property regulations, such as those pertaining to patents and trademarks, in order to safeguard their ideas and brands. They also need to follow competition rules in order to prevent anti-competitive behaviour. Furthermore, in order to guarantee product quality and consumer safety, compliance with ethical standards, such as those specified in the Indian Pharmacopoeia and Good Manufacturing Practices (GMP), is essential.

In general, a thorough comprehension of and adherence to these regulatory frameworks are necessary for good corporate governance in the Indian pharmaceutical business, which promotes responsibility, ethics, and openness.[30]

CONCLUSION

In conclusion, the legal aspects of corporate governance in the pharmaceutical industry are pivotal for ensuring ethical practices and public trust. As the industry evolves, future trends indicate a continued focus on transparency, accountability, and regulatory compliance. Implementing robust internal controls, fostering a culture of integrity, and leveraging technology for enhanced oversight are key solutions to mitigate risks and uphold governance standards. Moreover, collaboration between industry stakeholders, policymakers, and regulatory bodies will be essential to address emerging challenges and adapt to evolving legal landscapes. By proactively addressing governance issues and embracing ethical principles, pharmaceutical companies can not only safeguard their reputation but also contribute to the advancement of public health and well-being.

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[1] The Chartered Governance Institute UK & Ireland, What is corporate governance? The Chartered Governance Institute, https://www.cgi.org.uk/about-us/policy/what-is-corporate-governance#:~:text=Corporate%20governance%20is%20the%20system,accountability%2C%20and%20who%20makes%20decisions (last visited Apr 21, 2024).

[2] Emily Barr, The importance of corporate governance • sprigghr SpriggHR (2022), https://sprigghr.com/blog/board-management/the-importance-of-corporate-governance/ (last visited Apr 21, 2024).

[3] Omari William, The crucial importance of good governance in pharmaceutical sector LinkedIn (2023), https://www.linkedin.com/pulse/crucial-importance-good-governance-pharmaceutical-sector-william?utm_source=share&utm_medium=member_android&utm_campaign=share_via (last visited Apr 21, 2024).

[4] Office of the Commissioner, What we do U.S. Food and Drug Administration, https://www.fda.gov/about-fda/what-we-do (last visited Apr 24, 2024).

[5] About Us, About us | European Medicines Agency, https://www.ema.europa.eu/en/about-us (last visited Apr 24, 2024).

[6] About who, World Health Organization, https://www.who.int/about (last visited Apr 24, 2024).

[7] About PMDA, Pharmaceuticals and Medical Devices Agency, https://www.pmda.go.jp/english/about-pmda/index.html (last visited Apr 24, 2024).

[8] Health Canada, Government of Canada Canada.ca (2024), https://www.canada.ca/en/health-canada.html (last visited Apr 24, 2024).

[9] What is CFDA of China?, What is CFDA of china?-China FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics, health food supplement, medical device, IVD, drug, infant milk powder, dairy, pet food ,disinfectant etc., http://www.sfdachina.com/info/50-1.htm#:~:text=CFDA%20is%20abbreviation%20of%20The,competent%20authority%20of%20drug%20regulation (last visited Apr 24, 2024).

[10] The Investopedia Team, How does government regulation impact the drug sector? Investopedia, https://www.investopedia.com/ask/answers/032315/how-does-government-regulation-impact-drugs-sector.asp#:~:text=Mergers%20and%20acquisitions%20(M&As)%20are,potential%20for%20success%20in%20trials (last visited Apr 25, 2024).

[11] Corporate governance structure, HKEX Group, https://www.hkexgroup.com/Corporate-Governance/Corporate-Governance-Framework/Corporate-Governance-Structure?sc_lang=en (last visited Apr 25, 2024).

[12] Elvin Mahmudov, Benefits of an effective compliance and Ethics program LinkedIn (2023), https://www.linkedin.com/pulse/benefits-effective-compliance-ethics-program-elvin-mahmudov?utm_source=share&utm_medium=member_android&utm_campaign=share_via (last visited Apr 25, 2024).

[13] Anti-bribery and corruption policy, Principal, https://www.principal.com/about-us/our-company/policies/anti-bribery-and-corruption-policy (last visited Apr 25, 2024).

[14] ABOU NAJA              Intellectual Property & Abou Naja, 19 different ways to protect intellectual property ABOU NAJA, https://www.abounaja.com/blogs/protect-intellectual-property (last visited Apr 25, 2024).

[15] The law and ethics of the Pharmaceutical Industry, https://www.researchgate.net/publication/287460892_The_Law_and_Ethics_of_the_Pharmaceutical_Industry (last visited Apr 25, 2024).

[16] Legal text, General Data Protection Regulation (GDPR) (2024), https://gdpr-info.eu/ (last visited Apr 25, 2024).

[17] Office for Civil Rights (OCR), Hipaa Home HHS.gov (2024), https://www.hhs.gov/hipaa/index.html (last visited Apr 25, 2024).

[18] Daniel Buchanan, Navigating data privacy and regulatory challenges in healthcare IT LinkedIn (2023), https://www.linkedin.com/pulse/navigating-data-privacy-regulatory-challenges-daniel-buchanan?utm_source=share&utm_medium=member_android&utm_campaign=share_via (last visited Apr 25, 2024).

[19] Understanding the cybersecurity landscape in Pharma Tech, Qualifyze (2023), https://www.qualifyze.com/resources/blog/understanding-the-cybersecurity-landscape-in-pharma-tech/ (last visited Apr 25, 2024).

[20] EC-Council University, Cybersecurity risks and solutions for the pharmaceutical industry EC (2023), https://www.eccu.edu/blog/cybersecurity/cybersecurity-challenges-in-the-pharma-industry/#:~:text=FAQs:,trade%20secret%20theft%2C%20and%20counterfeiting (last visited Apr 25, 2024).

[21] Our governance, JNJ.com, https://www.jnj.com/caring/citizenship-sustainability/approach/governance#:~:text=The%20Executive%20Committee%20of%20Johnson,results%20by%20our%20Executive%20Committee (last visited Apr 25, 2024).

[22] Johnson & Johnson’s organizational structure [Interactive Chart], Organimi, https://www.organimi.com/organizational-structures/johnsonjohnson/ (last visited Apr 25, 2024).

[23] Pfizer Inc. – investor relations – corporate governance – corporate governance overview, https://investors.pfizer.com/Investors/Corporate-Governance/Corporate-Governance-Overview/ (last visited Apr 25, 2024).

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