INTRODUCTION

The issue of patent protection and its impact on drug accessibility and pricing is an important part of today's global intellectual property discourse. This debate continues to be a source of dispute, raising concerns about striking a balance between protecting patents and ensuring that vital pharmaceuticals are accessible and affordable around the world.

Millions of patients suffering from serious illnesses contend that the introduction of product patents into the Indian pharmaceutical industry has created a global health disaster. This change has mostly impacted people who were gaining access to the reasonably priced medications made by the generic medicine manufacturing industry in India. The repercussions have been severe, resulting in avoidable suffering and widespread hardship for the almost 2 billion people who lack access to basic medications. The Indian pharmaceutical business faces significant obstacles as a result of the application of product patents, which limit its capacity to export medications covered by patents or engage in reverse engineering. This change represents a dramatic change in the sector's dynamics, affecting its traditional methods and reach worldwide.

"One third of the world's population still lacks access to essential drugs while in the poorest parts of Africa and Asia, over fifty percent of the population does not have regular access to the most vital essential drugs." -M. Scholtz

Healthcare costs in India, where a large proportion of the population lives below the poverty line (BPL), have risen to worrying proportions. This stark reality highlights a major healthcare crisis characterized by shortcomings in healthcare provisions as well as difficulties linked to, affordability of medicines, its accessibility, and availability in the nation.

IMPLICATION OF PHARMACEUTICAL PATENTS ON HEALTH CARE SYSTEM IN INDIA

Undoubtedly, patents are important in allowing the pharmaceutical sector to recoup its investments and reinvest in future drug research and development. However, it is crucial to bear in mind that patents are a means to an end, rather than an end in themselves. The TRIPS treaty's "one size fits all" approach has drawn criticism because “it leads to unjust and burdensome outcomes for countries that are struggling to meet the most basic needs of their citizens”. It can be said that the TRIPS has taken away some of the member states autonomy. Considering the case of India, the Patent Act in 1970 to 1995, did not recognize pharmaceutical product patents. This beneficial circumstance enabled the Indian pharmaceutical industry to develop many generic medications, cementing its position as a global leader in generic drug manufacturing and giving affordable access to medicines in the country and around the world. However, the dynamics changed after the TRIPS agreement was implemented and a new patent regime was introduced in India. This transition has resulted in higher prices for medicines, making them unaffordable for many people in the country. While acknowledging the importance of patents, the shift in India's patent system has prompted worries regarding the ongoing availability and affordability of essential pharmaceuticals.

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It is critical to acknowledge that medications should not be viewed as ordinary commodities, given their inherent properties for treatment and therapy, which make them necessary components of health systems. These medications not only improve quality of life, but they also play an important role in lowering morbidity and death rates, supplementing other healthcare services. However, the commercialization of medications caused by patent monopolization is largely becoming a protection mechanism for private owners.

The pharmaceutical industry's pursuit of rigorous patent protection has resulted in an ongoing practice of artificially increasing drug costs over 20 years in order to maximize income. While this strategy may be acceptable in industrialized countries with working insurance systems and widespread access to necessary medicines, the situation is very different in developing countries like as India. Despite the availability of effective treatment options, the expense of vital drugs is frequently a virtual "death sentence" for many people in these situations. According to the Executive Summary of the Health in India Report, based on the NSS 75th cycle, the average out-of-pocket medical cost for hospitalization is around Rs. 15,937 in rural areas and Rs. 22,031 in urban regions. This emphasizes the stark truth that the pricing dynamics of medicines can have serious effects for the overall welfare and economic security of vulnerable communities in the country. This sets up a vicious cycle whereby poor living circumstances, coupled with starvation, lead to disease.

It is inherently unfair to deny people access to interventions that could save their lives or improve their health because of social or economic constraints. The relationship between healthcare accessibility, economic situations, and generational well-being stresses the need to tackle the broader socio-economic variables that lead to health inequities and intergenerational poverty.

Another important aspect that warrants our consideration is that the patent system is that While pharmaceutical patents encourage research and development (R&D) and the discovery of novel treatments, a large amount of these incentives are directed toward diseases that are financially profitable for the company. This emphasis on profitable diseases results in a significant disregard of "unprofitable diseases," which disproportionately impact the poor. issue, combined with the fact that most drugs are priced above the means of people in developing countries, gives rise to the so-called ‘global drug gap’. The World Health Organization (WHO) has expressed increased worry about the visible trend of pharmaceutical R&D aligning with market demands in industrialized countries. As a result, tropical diseases, particularly those impacting the developing world, are frequently overlooked in research and development efforts, aggravating global health inequities.

The World Health Organization (WHO) preamble states that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic and social condition.” This defines the human right to health as the entitlement to the highest feasible quality of both physical and mental well-being, including access to all medical services. It raises the crucial question of whether the current patent regime violates the fundamental values established in the WHO preamble. Furthermore, Article 21 of the Indian Constitution of 1950 lays an absolute obligation on the state to safeguard human life. The Supreme Court of India has time and again upheld that Article 21 includes the right to health.

The mismatch between the current patent regime and these constitutional and human rights principles raises serious ethical and legal questions concerning equal access to healthcare. The improvement of public health is emphasized in Article 47 of Part IV of the Indian Constitution's Directive Principles of State Policy. It clearly lays out the government's responsibility to control drug and medicine pricing and that citizens can obtain them at reasonable costs. Therefore, legislators must remember that upholding the "right to health" is a social and constitutional mandate. Any laws or rules that deny the impoverished population access to life-saving medications would be in contravention with this constitutional obligation.

WAY FORWARD

One potential solution to the problem of expensive medications in the nation is the establishment of a strong and effective pricing control system. The National Pharmaceutical Pricing Authority (NPPA) is in control of the Drug Pricing Control Order (DPCO), which is the main regulatory body that regulates drug costs in India. The government's ability to establish a price cap on necessary and life-saving medications is largely made possible by DPCOs. Some pharmaceutical corporations, however, use a strategy to exempt their drugs from DPCO rules by mixing chemicals that aren't covered by DPCO into already-approved drugs. Due to this the medications that are no longer under the DPCO's jurisdiction thereby increase in their cost. Crucially, these chemical modifications do not always increase the effectiveness of these medications. The government must act immediately to put an end to these dubious tactics used by pharmaceutical companies in the life-saving sector. Such measures are critical to averting possible harm to the nation's patients' lives and guaranteeing that necessary medications continue to be available and reasonably priced for those who require them. Other challenges of fair pricing exist on a scale of two extremes: high costs that make pharmaceuticals unaffordable in developing nations such as India, and overly low prices that may drive reputable manufacturers out of the market, resulting in medication shortages. The government's primary objective should be to develop a fair price model that ensures the availability of vital medications in sustainable quantities. This model should strive to set pricing that is not only affordable to patients, but also sustainable for third-party payers and health-care budgets. Striking this balance is critical for the successful implementation of a fair pricing strategy that addresses accessibility, affordability, and sustainability in the healthcare industry.

CONCLUSION

Access to affordable medicine is a major issue in a country like India, where a large proportion of the population lives below the poverty line. Individuals in poverty are unable to purchase expensive medicines, therefore many diseases eventually become a 'death sentence' for them, even when effective treatment exist. This highlights the patent system's substantial impact on healthcare accessibility, particularly in socioeconomic circumstances. The patent system needs to find the right balance between protecting patent holders' legal rights and furthering the public interest. It is conceivable that the patent system's tensions and imbalances will worsen if these problems are not resolved in a transparent and satisfactory manner. Furthermore, the market incentives for R&D that drive the current patent system have historically prevented investment in innovative products that target low-income communities. Due to this shortfall, there aren't many R&D projects that address the unique health requirements of the underprivileged. It is the pharmaceutical industry's responsibility to identify and rectify this gap in its efforts. Furthermore, India must make the most of the flexibility provided by the TRIPS to ensure that everyone has fair access to medications and to do away with all forms of discrimination. The Indian government ought to enact laws governing fair pricing, which would regulate the price of new medications at a level that would make them accessible to all patients and healthcare systems. In addition to providing a fair profit margin that will encourage continued innovation, this pricing plan should also guarantee a steady supply of generic medications. Putting such policies into practice is crucial to creating a healthcare environment where sustainability, equity, and accessibility are given top priority.

Author : Ayush Anand, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

REFERENCES

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