Patents and Public Health: State Responsibility to Opt for a Balanced Approach

Abstract

The topic of public health is indispensable to talk about. It is essential to discuss new inventions, new and improved treatments, and their efficiencies with different combinations, but one thing that is important to remember is whether these inventions are available for those in need. Availability concerns are linked with affordability, as the affordability of a drug determines its consumption; furthermore, affordability can lead to overconsumption. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement provides flexibility to control the misuse of patent monopolies. The object of this research is twofold: one is to investigate whether and how Pakistan incorporates TRIPS flexibilities in its national patent legislation, and the second is to find out the reason for unaffordable cancer treatment in Pakistan. This research highlights that the use of TRIPS flexibilities in Pakistan will help the state authorities to provide better health facilities to the public generally as well as particularly in cancer cases, as cancer treatment in Pakistan is unaffordable. The methodology applied for this research is primarily comparative and bears the qualitative aspect of the issue. This research concludes that Pakistan’s legal system fails to incorporate effective legal provisions related to TRIPS flexibilities, and it also highlights that the ever-greening of patents results in the high prices of cancer medicines in Pakistan. This research further recommended that there is a dire need to incorporate and use TRIPS flexibilities in the country to control the high prices of cancer treatment and cancer mortality rate in the country.

1. Introduction

Before the implementation of the TRIPS Agreement, states were free to adopt any legislative system regarding intellectual property rights (IPRs) that suited their national needs. After implementing the TRIPS Agreement, more than fifty states protected pharmaceutical patents for the first time [1]. The TRIPS Agreement binds the member states to implement intellectual property rights and give protection to pharmaceutical patents. The TRIPS Agreement affects public health and the affordability of medicines; hence, its implementation has become a matter of great concern globally. Global implementations of the TRIPS Agreement, particularly the inception of pharmaceutical patents, make the choice very hard for developing countries, including Pakistan. Trade relaxation and the implementation of the TRIPS Agreement are connected, and the choice to adhere to one is no longer available [2]. However, the TRIPS Agreement provides flexibilities for the member states, and by use of these flexibilities, state authorities can control the misuse of patent monopolies [3,4].

The Doha Declaration on the TRIPS Agreement and Public Health also clearly narrates that public health concerns will prevail whenever conflict arises between economic interests and public health. The use of TRIPS flexibility (compulsory licensing) can ensure access to affordable medicines [5]. This research will explore Pakistan’s patent law and the use of TRIPS flexibilities. This research further analyses the on-ground situation of cancer and cancer mortality rate in Pakistan. The availability and affordability of cancer medicines in Pakistan is also a matter of discussion. This study will try to find out the reasons for the huge price difference in cancer medicines between India and Pakistan by the same multinational pharmaceutical companies. This study also finds out how the use of TRIPS flexibilities can help cancer patients in Pakistan. This research also explores the Indian patent law and highlights how India used the TRIPS flexibilities to successfully provide affordable cancer treatment for its people. This research gives some suggestions for the legislature and policymakers regarding revamping Pakistan’s patent law and implementing comprehensive provisions of compulsory licenses to help poor cancer patients in Pakistan. It will also help to control the high prices of cancer medicines and the high mortality rate of cancer in the region.

This research starts with an introduction to the topic. Then, under Section 2, it designs the conceptual framework of this research, which will help the readers understand the importance of the current topic. This section also describes the research design, including the methodology and literature search. Section 3 deals with the challenges of the research and the sources from which we obtained data for this research. Section 4 deals with the first question of this research and refers to the comparative analysis of Pakistan’s and India’s patent laws. It also highlights how both jurisdictions used the TRIPS flexibilities. Section 5 discusses the results of the comparative analysis, revealing that India successfully incorporates TRIPS flexibilities in its national legislation, and Pakistan needs to do so. Section 6 is relevant to this research’s second question, providing data about cancer treatment and its cost and highlighting the patent status of different anti-cancer medicines in both jurisdictions. This section concludes that Pakistan frequently grants patents without using TRIPS flexibility or compulsory licensing. At the same time, India rejects the ever-greening of patents and issues compulsory licenses for cancer medicines to provide affordable anti-cancer medicines. Section 7 compares the patent status and price of anti-cancer medicines in India and Pakistan and reveals that the prices of cancer medicines in Pakistan are much higher than in India. Section 8 presents the reasons for the high prices of anti-cancer medicines in Pakistan, and Section 9 presents the conclusion.

2. Conceptual Framework

Before the formal start of this research, a conceptual framework is given for a better understanding. In this section, we will look at the right to health, the duty of the state in public health, and cancer as a threat to developing countries. We will also look at the health scenario in Pakistan. In the conceptual framework, we want to make some points clear. First, the right to health is the fundamental right of every human being everywhere in the world. Second, it is the duty of the state to protect public health; international human rights law also imposes this duty on the state. The third is to highlight the situation of expensive cancer treatment in Pakistan as a major issue.

2.1. Right to Health and Duty of the State toward Public Health

The right to health is a fundamental right of every human being, irrespective of religion, region, and race [6]. It is the basic right of every human being to be provided with appropriate health facilities whenever he needs it for himself or for those whom he cares for and loves [7]. The right to health and the right to life are interlinked; we cannot deviate from the dependency of these two rights [8]. Life requires performing one’s duties, taking good care of one’s family, and being a productive part of society, but when suffering from a disease and treatment is not available or affordable, one cannot perform one’s duties and becomes a burden to family and society. Good health ensures a decent and dignified life. The affordability of medicine is as important as the availability of medicines [9]. Unaffordability of medicine creates discrimination in society, which results in restlessness and agitation. Providing equality and justice in the health sector is indispensable to maintaining peace in society.

This research confines discussion to the right to health care (provisions of medical services) and not to the pre-conditions of good health (environment, safe water, sanitation, and food). This research discusses the state’s responsibility to provide health facilities to its citizens, including the affordability of medicines. If a medicine is not affordable for patients, its availability is useless. The usage of a medicine is linked with its price. This research will be confined to health facilities and the affordability of medicines.

It would not be wrong to say that the right to health is a relatively new concept in the era of rights. Before the eighteenth century, the health of people fell outside the range of state responsibility [10]. The concept of a welfare state emerged, and it was considered that the state is responsible for providing health facilities to its citizens [11]. All the international instruments and treaties put the responsibility for the health sectors on the state. Developing countries must be more vigilant and active in making appropriate legislation for emergencies in the health sector. In case of any natural disaster, pandemic, or contagious disease, developing economies are under more threat than developed economies due to their limited resources [12]. The state must incorporate effective provisions in its national legislation so that in case of any emergency, those provisions become active and facilitate the public. Proper legislation is the key duty of the state to make laws and take appropriate measures for the private sector (multinational pharmaceutical companies, private hospitals, labs) so that it cannot interfere with the health of its citizens [13].

2.2. Right to Health under the International Law

The right to health is internationally recognized. Many international agreements protect the right to health. Internationally, the World Health Organization is a specialized agency of the United Nations (UN) that deals with health concerns worldwide. The right to health has become part of international human rights law, and many international declarations and treaties protect the right to health. Some of the essential documents are as follows:

• Universal Declaration of Human Rights;
• International Covenant on Economic, Social, and Cultural Rights;
• Convention on the Rights of the Child;
• Alma Ata Declaration;
• Convention on the Elimination of all Forms of Discrimination against Women.

2.3. Global Burden of Cancer

Cancer has become a serious concern for all economies, and the burden of cancer is increasing every year. In 2008, there were 12.6 million cases of cancer; these numbers increased in 2018 to 18.1 million, and it is predicted that in 2040, there will be 29.4 million cases of cancer worldwide [14]. Every state has observed an increase in cancer mortality rate in the last 20 years; in 2018, 9.6 million and, in 2020, 10 million people died of cancer. It is also reported that one in six deaths occurs due to cancer [15]. A study conducted in China, Brazil, South Africa, and Russia in 2012 revealed that these states faced a loss of USD 43.6 billion due to premature deaths [16]. The World Health Assembly, in its resolution, acknowledged that in developing countries, a huge number of cancer patients affect the development of the state, especially when the most productive group of society (young people) is unable to perform their role. The WHO recognized that there are high morbidity and mortality rates due to cancer, and this is an alarming situation for developing countries. There is a need to provide adequate funding to start cancer prevention and control programs, but the cost of cancer treatment is high, and developing countries have limited health budgets; hence, governments are unable to subsidize the cancer treatment programs [17].

A WHO report on cancer highlights that early detection and proper treatment facilities can save the lives of 7 million people by 2030. In recent years, a lot of efforts and innovations have been made for the improved treatment of cancer; however, the uptake of these technologies and medicines is limited to high-income countries. There are many inequalities between the world’s nations regarding the availability of cancer treatment [18]. The use of TRIPS flexibilities is a good option for states to control the high price of medicine and minimize the mortality rate due to cancer. This usage is possible only if a state has appropriate laws and effective provisions. Protecting the right to health imposes a duty on the state to make and enforce policies and laws to ensure public health.

2.4. Right to Health in Pakistan

Pakistan is a low-middle-income country with a GDP of USD 5110 per capita (2018). Health spending is USD International 160.6 per capita. The share of out-of-pocket health spending is 66.5%, and it is the highest in the region. One doctor is available for one thousand people, and one nurse is available for two thousand people in Pakistan [19]. Pakistan’s health indicators are the worst among the other regional countries. The Global Human Development Index (HDI) report in 2019 places Pakistan way behind India, Bangladesh, and even the average of South Asia. Pakistan stands at position 152 among 189 countries in providing insufficient health facilities [19]. In Pakistan, the number of new cancer cases diagnosed in 2020 was 178,388, including 88,015 men and 90,373 women. The number of deaths in 2020 due to cancer was 117,149, and the number of prevalent cases in 2020 was 329,547. Lip and oral cancer are more common in men at 12.9% (11,395 patients), and breast cancer is more common in women at 28.7% (25,928 patients) [20]. Breast cancer is the most common in Pakistani women; in Asia, Pakistan has the highest burden of breast cancer mortality. Eighty-nine percent of cases of breast cancer are diagnosed at a late stage and are difficult to cure and treat [21]. Cervical cancer is very common in women with breast cancer, especially those who are under the age of 50 years. Cervical cancer is curable if diagnosed early, but the mortality rate is very high in Pakistan, as over 70% of patients are diagnosed at a late stage. Exact data about cervical cancer are not available in Pakistan as it is an ignored disease. In Punjab, a cross-sectional study was conducted, and the result revealed that 72% of cases of cervical cancer belong to the lower-income group of Punjab [22]. In Pakistan, almost twenty cases of cervical cancer are reported daily, and Pakistan is among the top ten countries with the highest mortality rate due to cervical cancer. Though these cases are fewer than in developed countries, the mortality rate is much higher due to late diagnosis and lack of treatment facilities [23]. There is apprehension that the actual incidence of cancer in Pakistan might be more than this as there is no proper system for the registration of cancer cases, and coordination among the provinces on data sharing is also missing. Due to the limited cancer treatment options and expensive diagnosis process, it is quite possible that many cancer patients remain without diagnosis, particularly in rural and undeveloped areas of Pakistan.

In Pakistan, the treatment facilities for cancer patients are quite inadequate. Government hospitals do not provide appropriate treatment facilities for the cancer patient. Cancer medicines are not available regularly; radiation machines are also available in small numbers. Radiation, though not curative, controls the pain, which is unbearable in the advanced stage of the disease [24]. Government hospitals in Pakistan have miserable conditions for providing cancer medicines. Medicines are provided but not regularly due to a shortage of funds or for many other reasons. No one knows when the supply of medicines will stop and for how long. As we saw on 19 September 2019, cancer patients protested in front of the Punjab Assembly because the Jinnah and the Mayo Hospital administration refused to give cancer medicines, and the treatment of the patients stopped. The hospital administration said that the government of Punjab withdrew its program due to the lack of funds [25]. On 18 February 2020, a protest was made by Prof. Dr. Masoodur Rauf, who had many people in front of the MS office against the shortage of life-saving medicines in Nashter Hospital Multan [26]. On 11 March 2021, cancer patients assembled at Kalma Chowk and stopped the Metro bus service as a protest. They demanded to continue the delivery of cancer medicines as it was stopped by the government [27,28]. Cancer treatment is very costly and almost unaffordable in Pakistan. As stated earlier, facilities are not available in the government sector. In the private sector, the facilities are available, but the cost of cancer treatment is so high that the majority of people cannot pay for it. Cancer is another name of death in Pakistan because of its expensive treatment. By incorporating and using the TRIPS flexibilities, the situation of cancer patients can be improved. It is the responsibility of the government of Pakistan to make progressive policies and amendments in the laws to reduce the suffering of its people.

2.5. Research Design

This research will find out how India and Pakistan incorporate the TRIPS flexibilities into their national legislation. The object of this paper is also to evaluate the high prices of cancer treatment in Pakistan and to find out how India successfully controls the prices of cancer medicines. To find out the answer, we designed this research in the following manner.

2.5.1. Research Methodology

A comparative legal research methodology has been applied to this research. This comparative approach will help understand the difference between the legal provisions of both countries, how India and Pakistan incorporate the TRIPS flexibilities in their respective national legislation, and how it affects the prices of cancer medicines. The reason for choosing this approach is that India and Pakistan have almost the same socio-economic conditions and share a long border, but multinational pharmaceutical companies are selling the same medicine in both countries with huge price differences. This study compares the policy and law of both jurisdictions (India and Pakistan) and comprehensively analyzes the key points in India’s patent law that contribute to controlling the price of patented cancer medicines in India. The comparative method helps us better understand Pakistan’s patent law and helps us address the current problem by utilizing India’s experience.

2.5.2. Literature Search

We used Google Scholar, Elsevier, and JSTOR databases to search for literature. We also searched and obtained data from the annual review reports of the WHO, which are available on the official website of the WHO. The data and information about the patent law of Pakistan, patent law of India, TRIPS Agreement, and Doha Declaration were obtained from the respective government official websites. We obtained data about the patent status of different anti-cancer medicines from MedsPal, a database developed by the Medicine Patent Pool and PAT-INFORMED hosted by the World Intellectual Property Organization (WIPO), and data about the cancer morbidity and mortality rate in Pakistan have been received from Globocan [29].

3. Challenges

No prior research was available on the patent status of cancer medicines in Pakistan. The patent office of Pakistan requires a difficult, time-consuming, and expensive procedure if anyone wants to know about the patent status of any medicines in the country. This might be a reason why this area has remained untouched by researchers. However, this research obtained data from MedsPal, and this study is restricted only to those medicines whose patent status was available on MedsPal.

In Pakistan, no data are available about the cancer morbidity and mortality rate on a national level. However, some research was conducted on the provincial level but provided limited data. Coordinating among the provinces and mobilizing the data nationally are necessary. This research obtained data from Globocan, and there is apprehension that the actual morbidity and mortality rate of cancer in Pakistan is higher than in this report. There is a possibility that many cases of cancer remain without diagnosis and treatment. This research is pioneering regarding its content, and it will open the way for researchers to evaluate patent law and analyze its effects on the cost of other medicines. This research suggests that TRIPS flexibility is the only hope for patients in low- and middle-income countries to avoid exorbitant prices.

4. Comparative Analysis of Patent Law of Pakistan and India and Use of TRIPS Flexibilities

This section deals with the first question of this research, which is whether and how Pakistan incorporates the TRIPS flexibilities into its national legislation. To obtain the answer to this question, we will discuss the relevant provision of patent law of Pakistan, and we will also have a look at the patent law of India as it will help us to find the difference between the two legislations.

4.1. Use of TRIPS Flexibilities in the Patent Law of Pakistan

The TRIPS Agreement puts some obligations on the member states to provide minimum protection standards to implement IPRs, but it also provides flexibility. A compulsory license is an essential flexibility the TRIPS Agreement provides to control the misuse of patent monopolies. The TRIPS Agreement does not provide grounds for granting compulsory licenses, and states are free to decide the grounds according to the requirements of its people. The Doha Declaration on the TRIPS Agreement and Public Health also asserts expressly in paragraph 5(a) that “Each Member has the right to grant compulsory license and the freedom to determine the grounds upon which such licenses are granted”. Using this flexibility would help the member countries to perform their obligation properly in the health sector.

Articles 58 and 59 of the Patent Ordinance 2000 provide provisions for compulsory licensing. Article 58 provides four grounds for the federal government to issue a compulsory license and exploit the invention. Exploitation shall be limited to that particular purpose for which it is given, and the owner of the patented invention shall be paid adequate remuneration, which the federal government will determine according to the economic value of the authorization. The first ground for granting a compulsory license is when “the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy so requires” [30]. On this ground, certain terms need development and explanation, such as what constitutes “public interest” and what includes “national security”. The second ground can be invoked when the practice by the “owner of the patent or his licensee is anti-competitive” and the federal government is authorized to issue a compulsory license to cure such practice. Here, the term anti-competitive must be adequately explained. The third ground is when “the patent holder refused to grant a license to a third party on reasonable commercial terms and conditions”. The fourth ground is related to circumstances “where the patent has not been exploited in a manner which contributes to the promotion of technological innovation”. No procedural rule is provided for the practical application of Section 58. Due to a lack of rules and regulations, the compulsory license provisions are a waste of time and inactive.

Article 59 also provides the grounds to grant a compulsory license by the controller on the request of any interested person on the reason for non-working; again, the term non-working needs to be explained. There is a dire need to review the compulsory licensing provisions and explain the administrative process to make it workable and helpful in making the availability of medicines easier.

4.2. Compulsory License for Export or Import of Patented Medicine

The patent law of Pakistan does not have any provision to issue compulsory licenses for importing or exporting patented medicines. Compulsory licensing provisions of Pakistan’s patent law did not take benefit from the Doha Declaration and the Decision of 30 August. The decision allows the member countries to incorporate provisions in their national legislation for issuing compulsory licenses and importing drugs from other countries if the country does not have manufacturing capacity. This relaxation aims to ensure the right to health even for countries that do not have manufacturing capacity. Before the Decision on 30 August 2003, the countries that did not have the manufacturing capacity for medicine could not issue compulsory licenses, but now this problem is solved. This flexibility is available only when countries incorporate this provision in national patent law.

4.3. TRIPS Flexibilities under the Patent Law of India

Section 84 of the Indian Patent Act 1970 deals with the compulsory license. Section 84 provides a detailed procedure for compulsory licensing without leaving any ambiguity, and all relevant terms are explained well by utilizing TRIPS flexibilities.

Three grounds are provided for the granting of the compulsory license: the first ground can be invoked when the patented invention fails to fulfill the “requirement of the public” and the second ground becomes active when the invention is not available to the public at affordable prices. The third ground becomes relevant when the patented invention has not been worked on in India. The Controller may issue a compulsory license at the request of any interested person three years after the granting of the compulsory license if satisfied that the circumstances under Section 84(1) exist. To remove any uncertainty and widen the range of circumstances to issue compulsory licenses, the Patent Act further explains in detail under Section 83 the conditions that will be considered as the nonworking of the patent system. It also elaborated in detail under Section 84(7) for when the requirement of the public will be considered as not fulfilled.

Section 83 explains in detail the conditions that, if not fulfilled, would be deemed as non-working of the patent and may become a reason to issue a compulsory license. Section 83(a) states that patent protection is given to encourage invention on the one hand and to ensure the invention works on a commercial scale in India on the other. If an invention fails to work commercially within a reasonable time, then it will be considered that the requirement to work in India is not fulfilled, and it would be a valid ground for granting the compulsory license. Section 83(b) further elaborated that the patent is not granted just to enjoy monopoly by the patent holder or so that he has exclusive control over the market, but the object behind this protection is to ensure the transfer of technology, and this object is demolished by the importation of patented products by the patent holder. It is a very useful provision and would be very effective if implemented because local production transfers technology and creates job opportunities for the local community.

Section 83(c) explains that if patent protection does not contribute to the transfer of technology, dissemination of technology, or the promotion of technological innovation, then it means that the patent is not working in India. Section 83(d) makes it clear that patent protection should not impede the right to health but should help promote public health and welfare. Section 83(e) further endorses that patent protection does not in any way handicap the government to perform its duties to protect public health. Section 83(f) narrates that the patent holder or any person deriving title from him should not misuse his rights, and in no way is he allowed to restrain trade or create any hurdle in the international transfer of technology. Section 83(g) claims that the patentee must ensure that the patented invention must be available to the public at affordable prices. In our opinion, this provision is very important and significant for poor countries where it is difficult for people to bear their household expenditures, and high prices of medicine deteriorate the situation. Due to the high prices of medicines, the object of invention to serve for the mutual benefit of the producers and users is to stop working.

Patent Act 1970 of India under Section 84(a) describes the grounds for granting a compulsory license. If a patent fails to fulfill the requirement of the public, a compulsory license may be issued if requested by any interested person. It did not leave the term “public” unexplained and explains the term very impressively. Section 84(7) narrates the conditions in the absence of which it will be deemed that the requirement of the “public” is not fulfilled if the patent holder:

• refused to grant a license to any interested person on reasonable terms and conditions;
• prejudices any trade or industry;
• is unable to fulfill the demand for patented articles adequately;
• fails to develop a market for export.

The Patent Act of India utilizes this flexibility to the greatest extent. It covers all the aspects very well; maximum grounds are added, and India is efficiently trying to reduce the consequences of exclusive patent monopoly.

5. Results of the Comparative Analysis

We have reviewed Pakistan and India’s compulsory license provisions and analyzed Pakistan’s patent law, which provides limited grounds for the granting of compulsory licenses. Instead of limited grounds, there is a lack of practical application of these grounds. Under Article 58, four grounds are provided when the Controller may ask the federal government to issue a compulsory license, but no rules and regulations are provided about the practical application of Article 58. The grounds provided are restricted in nature, and local industries cannot benefit from Article 58. Without the practical application of Article 58, the compulsory license provisions are a waste of time and inactive. In Article 59, the Controller may issue a compulsory license at the request of any person, and local industry may benefit from it, but only one ground is provided to issue a compulsory license, which is “non-working” of the patent. The term “non-working” is not explained. We found that, under Indian patent law, there are four grounds for any interested person to ask for the granting of a compulsory license, and the non-working of patents in India is also one of these grounds. The term “non-working” is explained intelligently by the Indian legislature which includes seven more grounds, which we have already mentioned above. Indian patent law explicitly narrates that if an invention is not affordable for the public, it means that the invention is not working in India, and a compulsory license may be issued. There is a dire need to review the compulsory licensing provisions in Pakistan’s patent law immediately and include more grounds in it as India did.

Pakistan does not have provisions for issuing compulsory licenses for the import and export of patented medicines, but Indian patent law has provisions for issuing a compulsory license for the import and export of patented medicines. Pakistan must incorporate this flexibility in its national legislation because it does not have the manufacturing capacity for cancer medicines. Not incorporating the Decision of 30 August 2003 means that Pakistan cannot issue a compulsory license for anti-cancer medicines. This might be a reason why multinational pharmaceutical companies are selling cancer medicines at exorbitant prices in Pakistan because these companies know that Pakistan does not have the manufacturing capacity and cannot issue a compulsory license for the import of cancer medicines.

6. Cancer, Its Cost, and Patent Status of Different Anti-Cancer Medicines in Both Jurisdictions (India and Pakistan)

Cancer is the main cause of death all around the world [31], and this is also the case in Pakistan [32] and India [33]. This research highlights that there is a huge price difference for anti-cancer medicines in India and Pakistan by the same multinational pharmaceutical companies. The second question of this research is to find out the reasons for the high prices of anti-cancer medicines in Pakistan and to find out the ways by which India successfully controls the price of anti-cancer medicines.

6.1. Cancer and Patent Status of Different Cancer Medicines in Pakistan

Limited data on cancer morbidity and mortality rates are available on the national level, and the available data provide statistics about different regions like Lahore or Karachi. Health became a provincial subject after the 18th Amendment to the Constitution of Pakistan, so there is a lack of research and coordination among the provinces regarding cancer statistics. There is a need to mobilize national efforts to collect data about cancer morbidity, mortality, and possible risk factors to control the prevalence of cancer. In Pakistan, it is very difficult to know the patent status of any medicines. The Intellectual Property Office of Pakistan is unable to design a user-friendly website. It does not provide a database where patent information is provided. It requires a difficult procedure. If anyone wants to know the patent status of any medicine, then the interested person has to fill out a form along with the prescribed fee and then wait for the reply from the Intellectual Property Office. This is the reason why researchers have not worked on this highly important area.

Sorafenib, brand name Nexavar, is an anti-cancer drug that is used to treat liver and kidney cancer. Bayer filed a patent for sorafenib on 6 March 2008 in Pakistan, which was granted [34]. The price of patented Nexavar (sorafenib) in Pakistan is PKR 120,000 for a pack of 6o tablets. The one-month treatment cost of patented Nexavar is approximately PKR 240,000 [35]. Nilotinib, brand name Tasigna, is an anti-cancer drug. Novartis filed a patent for nilotinib benzamide-free base and salt on 17 September 2006 in Pakistan, which was granted on 25 April 2016 [36]. PKR 342,000 is the monthly treatment cost of nilotinib (Tasigna) without any combination of other chemo drugs [37]. Imatinib, brand name Glivec, is used to treat cancer patients. It helps to stop the growth of cancer cells or slow their growth. Novartis filed a patent for the imatinib tablet and it was granted [38]. The treatment cost of one month is approximately PKR 270,000 without the combination of any other chemo drug [39]. The above-mentioned price is just the cost of the one-month treatment, excluding the cost of consultancy, diagnosis, surgery, and radiotherapy.

One-third of the population of Pakistan is living below the line of poverty. The average monthly earning in Pakistan is USD 150, which is approximately PKR 30,000 [40]. This means that a cancer patient who earns PKR 30,000 a month must pay his whole year’s earnings to purchase medicines for one month. Due to the high cost of cancer medicines, many patients never start treatment [41] and live their lives at the mercy of fortune. Many people who started treatment have to abandon their treatment due to the unaffordable cost [42,43].

Pakistan’s pharmaceutical industry produces only 2% of the cancer medicines used in Pakistan; more than 50% of medicines used in Pakistan to treat cancer are of Indian origin, and the rest of the medicines are purchased from China, Europe, and the United States [44]. In Pakistan, oncologists prescribe conventional anti-cancer medicines and avoid prescribing new and patented anti-cancer medicines because these medicines are not affordable for most people in Pakistan. The most commonly prescribed medicines to treat cancer in Pakistan are etoposide, cyclophosphamide, and cisplatin. These medicines are affordable, and the generic versions of these medicines are also easily available in the market [45]. Cyclophosphamide was discovered in 1950 [46]. Cisplatin is used for chemotherapy. In 1978, the FDA approved it for the treatment of cancer patients [47]. In 1966, etoposide was first synthesized, and it received approval from the FDA to treat cancer in 1983. It is used as chemotherapy medication and helps treat different cancer types [48]. This indicates that patients in Pakistan are relying on old treatments, and they are not receiving benefits from new and advanced technologies as these technologies are unaffordable for them. Pakistan is just protecting foreign patent monopolies, and poor cancer patients are not treated with new patented medicines due to their high prices.

6.2. Cancer and Patent Status of Different Cancer Medicines in India

Cancer is the leading cause of death all around the world, and India ranks third in the world in terms of the number of cancer cases. According to the Indian National Cancer Registry Program, in 2021, there were approximately 13 cases of cancer in the country. The Indian Council of Medical Research (ICMR) issued its report and estimated that there will be a 12% increase in cancer cases in India in the next five years. In India, more than 53% of cancer patients receive free cancer treatment, and almost 27% of cancer patients receive cancer treatment at subsidized prices [49]. Some of the private hospitals in India are providing state-of-the-art health facilities and giving hope for millions of cancer patients worldwide. Apollo Proton Hospital in India welcomes cancer patients from 147 countries for cancer treatment and helps cancer patients fight cancer. They offer cancer treatment with the latest medicines at an affordable cost. Many people from Bangladesh, Kenya, Brazil, Bangalore, Zimbabwe, and other countries undergo successful cancer treatment from Apollo Proton Hospital [50].

Bayer, a German pharmaceutical company, successfully obtained a patent for sorafenib, brand name Nexavar, an anti-cancer drug used to treat liver and kidney cancer, on 3rd March 2008. Bayer was charging very exorbitant prices for Nexavar. Bayer set the price as RS. 2.8 lakh for one month of treatment. Due to the high cost of anti-cancer drugs, it became unaffordable for many cancer patients in India. Natco, a local pharmaceutical company in India, moved an application on 29 July 2011 for the compulsory license and offered to sell generic sorafenib at RS. 8880 per patient for one month of treatment. Natco claimed that it offers low prices, keeping in view the poor cancer patients in India. The Indian Patent Office granted its first compulsory license under Section 84 as a reasonable requirement of the public that has not been fulfilled by Bayer [51]. Public health supporters appreciate the decision of the Indian Patent Office. They think that the decision will pave the way for pharmaceutical companies to come forward and apply for compulsory licenses for other unaffordable drugs. This decision also sent a very strong message to multinationals that they should control the exorbitant prices of their patented products in India; otherwise, they will face compulsory licenses.

Novartis filed a patent for its anti-cancer medicine nilotinib, brand name Tasigna. A patent was filed in 2003 and granted in 2009; the expected expiry date was 2023 [52]. The treatment cost of Tasigna is approximately RS. 50,000 for one month of treatment [53]. The patent for nilotinib will expire in 2025, so the treatment cost is expected to be more affordable. Novartis filed a patent for its branded product Glivec (imatinib mesylate) in India, which is used to treat blood cancer and is more common in eastern countries. In 2006, the Indian Patent Office rejected Novartis’s patent for Glivec under Section 3(d). The patent office claimed that it is the modified version of the already existing imatinib and will not come under the definition of invention [54]. The one-month treatment cost for imatinib is RS. 13,000 [55]. Due to the lack of patents, many other companies also make and sell generic imatinib at a more affordable price.

In India, many companies manufacture anti-cancer drugs for domestic use and for export purposes. When we talk about the manufacturers of cancer medicines in India, we find many names like Beta Drug Ltd., Medion Biotch, AstraZeneca, S.G. Biopharm, Zuvius Lifescience, Jaj oncology, etc. [56]. The Indian pharmaceutical industry is fulfilling the needs of its cancer patients and is ready to export. It is already exporting off-patented cancer medicines all around the world.

7. A Comparison of Patent Status and Price of Anti-Cancer Medicines in India and Pakistan

Here are the names of some anti-cancer medicines and their price and patent status in India and Pakistan. It will help us see how a large price difference exists between the two countries that share a long border and many similarities in their socio-economic conditions.

This list is not exhaustive; we just give the names of a few cancer medicines in

Table 1. Names of a few cancer medicines used in Pakistan.

Name of Cancer Medicine	Price of Medicine in Pakistan for One Month of Treatment/Patent Status	Price of Medicine in India for One Month of Treatment/Patent Status
Glivec (Imatinib)	270,000/Granted	13,000/Patent Rejected
Tasigna (Nilotinib)	342,000/Granted	50,000/Granted
Nexavar (Sorafinib)	240,000/Granted	8800/Compulsory License is Issued
Opsumit (Mecitentan)	166,725/NA	1750/Granted
Herceptin (Transtuzumab)	130,000/NA	5000 to 10,000/Patent Rejected

. There are many other anti-cancer medicines that are sold in Pakistan at a much higher price than in India. However, we confined our study to only five medicines. We found that Pakistan has failed to control the price of anti-cancer medicine. Multinational pharmaceutical companies are selling their patented medicines (Tasigna and Opsumit) at affordable prices in India, but the same cancer medicines are available in Pakistan with a huge price difference. These multinational companies know that India will use TRIPS flexibilities (compulsory licenses) to control the price of medicines as it did in the case of Nexavar, while, on the other hand, compulsory licensing provisions under Pakistan’s patent law are not workable. India also has strict patentability criteria, so it rejects patents and controls the ever-greening of the patent system, but Pakistan does not have strict patent ability criteria, so multinational pharmaceutical companies easily obtain patents and then exploit them fully.

8. Discussion

A detailed analysis of the patent law of India and Pakistan and a comparison of the patent status and price difference of cancer medicines in India and Pakistan raised very important points in our discussion. A single department cannot ensure affordable medicines, but multiple actors are involved to ensure affordability. We have seen that there is a huge difference in prices of cancer medicines by the same multinational pharmaceutical companies in India and Pakistan. There are many factors that led to the high price of cancer medicines in Pakistan. We found out that the patent law of Pakistan is not fully equipped with effective grounds for compulsory licensing, and Pakistan cannot issue a compulsory license in case of any health emergency. Pakistan does not have provisions to issue compulsory licenses to import medicines from other countries. Pakistan’s local pharmaceutical industry cannot manufacture cancer medicines, which means Pakistan cannot issue compulsory licenses for cancer medicines. Failure to adopt and use adequate compulsory license provisions results in the high prices of cancer medicines. Weak provisions of law failed to keep a check on multinational pharmaceutical companies, and multinational pharmaceutical companies realized the fact that the patent law of Pakistan has no teeth. India has performed better. Indian patent law has very forceful grounds for granting compulsory licenses, and by having and using compulsory licenses, India controls the price of cancer medicines and gives a very strong message to multinational pharmaceutical companies that public health is the priority of the state.

Excessive patent protection is provided in Pakistan, and it leads to many new patents and the ever-greening of existing patents. The TRIPS Agreement allows the states to determine the criteria for patentability. Criteria for patentability are flexible in Pakistan; hence, many patents are granted. Pakistan frequently grants patents even for medicines for which India has rejected patents. This excessive granting of patents is also a leading reason for the high price of cancer medicines in Pakistan. The patent office grants patents to multinational pharmaceutical companies irrespective of whether these companies manufacture these medicines locally or import the medicines. There is a dire need to adopt strict patentability criteria to control the ever-greening of patents. The government of Pakistan should make effective laws and policies keeping international standards, the practices of other states, and the needs of its local people in view. Local needs and local industry are ignored while making laws and policies in Pakistan. It protects just the rights of technology producers and ignores the rights of the users of technology, so there is a need to create a balance. In Pakistan, there is a lack of local production, and multinationals dominate, especially for cancer medicines [57]. Local production of cancer medicines by multinational pharmaceutical companies has not started [58]; the medicines are imported and packed in Pakistan. Pakistan should bind multinational pharmaceutical companies to start local production houses in Pakistan so that the technology is transferred in a real sense as prescribed by the TRIPS Agreement.

The health sector in Pakistan is controlled by the government of each province. Health coverage in government hospitals is inadequate, and most of the time, patients have to bear their own health expenditures. The government should make serious efforts to control and subsidize the prices of cancer medicines. The government should play its role in controlling the price of cancer treatment in Pakistan by capacity building, improving access to cancer medicines, reshaping its policies, and also starting some initiatives to promote local production of cancer medicines by local pharmaceutical companies.

9. Conclusions

After making a critical analysis of the patent law of both jurisdictions (India and Pakistan) and after examining the status of cancer treatment costs in both jurisdictions, we can conclude that India incorporated and used TRIPS flexibilities very efficiently, hence enabling the control of the prices of cancer treatment in India. India successfully incorporated strict patentability criteria, stopped the ever-greening of patent patents, and eased the way for generic producers, ensuring affordable access. India used its compulsory license provisions and opened the way for the generic entry of anti-cancer medicines in India. By issuing the compulsory licenses, India gave a very strong message to multinational pharmaceutical companies that public health is India’s primary objective. Cancer treatment cost is very high in Pakistan; it grants patents on cancer medicines frequently, and this results in the high cost of patented treatment. Proper use of TRIPS flexibilities is not seen in Pakistan, and non-usage makes the situation more vulnerable for cancer patients in Pakistan. Multinational companies sell their patented cancer medicines in Pakistan at very high prices as these multinational companies know that the patent law of Pakistan has no teeth to defend the rights of its people. Pakistan should learn from the Indian patent law. It should include the TRIPS flexibilities in the Patent Ordinance 2000 to make it useful for local people instead of just protecting foreign patents. Pakistan should strengthen its compulsory license provision and should also make some procedural rules to make compulsory licensing provisions active. There is a need to add a provision for compulsory licenses for importing medicines, as Pakistan’s pharmaceutical industry does not have the capacity to manufacture cancer medicines. Pakistan should incorporate more effective and strong grounds for granting compulsory licenses. It must add high prices of medicines to the ground because Pakistan is a low-middle-income country, and citizens have to pay for their health expenses out of pocket. The government of Pakistan cannot provide health facilities to its citizens free of cost due to its limited resources, but incorporating appropriate provisions of law and making effective policies can minimize the suffering of its people in the health sector.