Still being edited – Sources missing
I. Introduction
Access to affordable and essential medicines and medical care is fundamental to global public health. And despite the fact that patents are intended to promote innovation and progress, their impact on the development and access to life-saving drugs has been a subject of increasing concern. The current patent system, which grants exclusive rights to pharmaceutical companies to produce and sell drugs, has led to high medicine prices, limited the scope of research, and limited access to care for many people, especially those in developing countries. Pharmaceutical companies often charge high prices for their patented drugs, which many people cannot afford, resulting in unequal health outcomes. It is crucial to critically evaluate the patent system in the medical field and explore alternative ways to promote innovation, ensure access to medication, and improve the health of people around the world.
This research paper discusses the issue of patents in the medical world, drawing on several sources, including “Patients not patents: Drug research and development as a Public Enterprise ” “Academic Patents and Access to Medicines in Developing Countries ” “Is the Patent System a Barrier to Inclusive Prosperity? The Biomedical Perspective ” and “Making Medicines Accessible: Alternatives to the Flawed Patent System ” The goal of these papers is to explore the flaws in the current patent system and the role of pharmaceutical companies in medicine access and medical care. Overall, this paper emphasizes the importance of finding a solution to the issue of patents in the pharmaceutical and medical world.
II. Flaws in the Current Patent System
The current patent system allows pharmaceutical companies to patent new drugs and prevent other companies from manufacturing and selling generic versions of those drugs for a fixed period of time, usually around 20 years. This gives the patent holder a monopoly on using, producing, importing, and selling the drug, which allows them to charge high prices to recoup their research and development costs and make a profit.
On one hand, proponents of strong intellectual property laws argue that they incentivize innovation and help ensure that pharmaceutical companies are fairly compensated for their research and development efforts. This, in turn, can lead to the development of new and effective medicines that benefit everyone.
On the other hand, critics argue that strong intellectual property laws can create barriers to medicine access, particularly in developing countries where access to affordable medicines is already limited. They argue that the high cost of patented medicines can make them inaccessible to the poor, leading to significant health disparities between developed and developing countries. Other studies have shown that the use of patents to encourage innovation in healthcare is ineffective and counterproductive. The patent system prevents researchers from sharing their ideas and promotes wasteful practices. Ironically, stronger patent protection may even lead to less innovation. When patents expire, drug companies frequently sue competitors to prevent them from selling cheaper generic versions. The European Commission estimated that these legal battles had cost the EU €3 billion over an 8-year period.
Before the mid-1990s, pharmaceutical product patents were not permitted in many developing nations. This decision was often a deliberate policy choice, based on the belief that the advantages of low-cost access to medication outweighed any potential negative consequences resulting from the absence of domestic patents on multinational companies’ research and development decisions. However, since the World Trade Organization’s adoption of the Trade-Related Intellectual Property Rights (TRIPs) agreement in 1995, all countries have been required to allow pharmaceutical product patents. In the post-TRIPs era, there is a widespread apprehension that the patents will increase prices, which in turn will restrict access to essential medicines in developing countries.
The current patent system has several flaws that can lead to high medicine prices. For example:
- Patent monopolies allow pharmaceutical companies to charge exorbitant prices for essential medicines. This can make them unaffordable for many people, particularly those in developing countries who cannot afford to pay high prices for life-saving treatments.
- The high cost of drug development is often used as an argument to justify high drug prices, but the actual cost of drug development is often overstated. Pharmaceutical companies often spend more money on marketing and lobbying efforts than they do on research and development. Independent analysts have estimated the cost of developing a new drug to be significantly lower than the industry’s claim of around US $1 billion, and the Drugs for Neglected Diseases Initiative (DNDi) believes they can develop a new drug for $110 million to $170 million. These costs include a theoretical expense for failed projects. Ultimately, drug prices do not reflect research and development expenses but rather what heavily subsidized “markets” are willing to pay. Making private insurance more expensive, as well as government-supported healthcare thus wasting tax money.
- Pharmaceutical companies can extend their patent protection by making minor changes to a drug or by obtaining multiple patents on the same drug. This practice, known as “evergreening,” can extend a drug’s patent protection for years and prevent the development of generic versions. The strategic value of patents has expanded beyond their role in promoting innovation. Even if a patent does not generate revenue, it can still be highly valuable for its strategic benefits. Using a patent as a blocking strategy is common practice
- The current patent system does not incentivize the development of medicines for neglected diseases that primarily affect people in developing countries. This is because there is often little profit to be made in developing treatments for these diseases.
On top of increasing prices and access to drugs the current patent has other significant flaws:
- “The European Commission has estimated that adverse reactions kill about 200 000 EU citizens annually at a cost of €79 billion.” A lot of deaths could have been prevented because our profit-driven healthcare system encourages excessive prescribing, and many patients may not have needed the drugs that ended up killing them, but the profit generated by these drugs creates an incentive to keep manufacturing and prescribing them. This system is both unethical and inefficient because people may die without access to necessary medications as well as overmedication. On top of that knowledge is not shared, leading to redundant work and missed opportunities for discovery.
- “Like a poorly conceived new drug with deadly side effects, the modern medicine patent regime is a relatively recent innovation and, not a good one.” International trade agreements, such as the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), have further complicated the issue of medicine access. TRIPS requires member countries to implement strong intellectual property laws, including patent protection for pharmaceuticals. However, this has been controversial, as it can make it difficult for developing countries to produce or import affordable generic versions of patented medicines. According to the World Bank: “Nothing is more controversial in TRIPS. […] Many developing countries see little potential benefit from introducing patents. In contrast, potential costs could be significant.”
Overall the increase in high-quality medicine significantly decreased illness and death rates caused by diseases in developed nations in the previous century. Nonetheless, today, a substantial number of people, approximately 2 billion, particularly those in developing nations, do not have access to vital drugs that could save their lives. The patent system should not control the biomedical technology sector because these technologies are crucial to people’s well-being and, in some cases, can mean the difference between life and death for patients. Instead, the entire biomedical sector should be excluded from the patent system and not be controlled by private companies through their patent monopolies.
Alternative methods of ensuring that medicines remain affordable and accessible to everyone include open-source drug development, prize funds for drug development, compulsory licensing, and patent pools. These alternatives aim to promote innovation while ensuring that essential medicines are affordable and accessible to everyone who needs them. I will describe alternatives more in detail in part 4.
III. The Role of Pharmaceutical Companies
The pharmaceutical industry is a massive global business, worth billions of dollars each year. It is made up of numerous companies that develop, manufacture, and market drugs and medical devices. Corporate interests play a significant role in the pharmaceutical industry, as these companies are driven by the need to make a profit. This profit motive can sometimes conflict with public health interests.
This maximization of profits leads them to concentrate on developing drugs to treat widespread chronic illnesses. However, they often create minor variations of existing drugs that are patentable but do not provide any additional therapeutic benefits. The current healthcare system does not provide sufficient incentives to research and develop cost-effective non-drug interventions, which may actually be more beneficial. A significant portion of healthcare spending is on drugs to treat conditions like type 2 diabetes, hypertension, and high cholesterol, which are largely caused by poor diet and a lack of exercise. Implementing policies like stricter regulations on unhealthy foods and drinks, subsidized healthy school meals, and courses on preparing nutritious and affordable meals can help people lose weight, making drugs unnecessary. Similarly, the increasing use of psychiatric drugs has led to an increase in disability pensions in many countries. In most cases, psychotherapy is a better option than medication as it has a greater chance to reduces the risk of suicide.
Pharmaceutical companies also engage in aggressive marketing practices to increase sales, which can lead to the overuse and misuse of medicines. Regulatory standards in the field of cancer treatment are notably inadequate. Despite the exorbitant costs associated with many cancer drugs, numerous drugs have been approved without the support of a single randomized trial and with only surrogate outcomes, such as disease-free survival rather than longer lifespan. Additionally, newly developed cancer drugs are typically not superior to existing ones, and their use may only increase survival by one or two months at most. This creates lots of waste: “Only 11 (1%) of 1032 new drugs approved in France between 2005 and 2014 were considered real advances” (We can expect this number to be similar in most developed nations) Furthermore, pharmaceutical companies are known to lobby for strong intellectual property laws, reduced drug trials, engage in legal battles to protect their patents, limiting competition and further driving up the cost of essential medicines. Some companies have increased the price of drugs by a significant amount by just acquiring patents.Turing Pharmaceuticals raised the price of Daraprim tablets from $13.50 to $750 each, causing the annual cost of treatment for some patients to increase to thousands of dollars. Similarly, Rodelis Therapeutics increased the price of Cycloserine from $500 to $10,800 for 30 pills.
The research done by pharmaceutical companies is often focused on profitable markets. Only around 1% of newly developed drugs in the late 20th century were for tropical diseases like African sleeping sickness, dengue fever, and leishmaniasis. Companies are driven to make a profit and satisfy their shareholders, so it’s not surprising that expensive research and development is more focused on illnesses prevalent in developed countries that can afford to pay for these drugs. Drug companies invest in what will yield the highest returns, and this often leaves people in poorer countries without access to essential medicines. For example, the patent system provides incentives for developing drugs that cater to the needs of affluent nations, such as those for male pattern baldness. However, it does not encourage research and development of medications that address the illnesses which affect and cause death to many impoverished people worldwide. Other examples are drugs for erectile dysfunction and acne while neglecting the research and development of medications to treat diseases that affect the poor and cause widespread suffering and death. As a result, only a single new drug has been introduced in the past 50 years to treat tuberculosis, which claims the lives of millions of people each year.
The impact of these practices can be devastating, particularly for patients in low- and middle-income countries who cannot afford to pay high prices for essential medicines. This has led to calls for greater transparency and accountability in the pharmaceutical industry, as well as for stronger regulatory oversight to ensure that medicines are priced fairly and are accessible to everyone who needs them.
The need for transparency and accountability in the pharmaceutical industry has become increasingly urgent in recent years, as global public health challenges such as the COVID-19 pandemic (which will only increase with climate change) have highlighted the critical importance of access to affordable medicines and medical devices. We can only reach immunity by giving access to vaccines to everyone. Or at least opening patents for productions. By promoting transparency and accountability, policymakers can help ensure that the pharmaceutical industry serves the needs of public health, rather than just the interests of corporate shareholders.
This includes greater transparency in pricing and research and development costs, as well as the need for stronger regulation to prevent marketing practices that prioritize profits over public health. It also includes ensuring access to clinical trial data and increasing public funding for research and development of essential medicines. It is also important to rethink the way with patent medical research and start thinking about open-source alternatives.
IV. Potential Solutions
Alternative methods of ensuring affordable and accessible medicines include policies such as:
- Compulsory Licensing: This policy allows governments to license the production of a patented medicine to a generic manufacturer, without the permission of the patent holder. This can help to increase competition and lower the price of essential medicines.
- Patent Pooling: This policy involves the creation of a collective patent license, allowing multiple organizations to access and use patented technologies or medicines. This can help to increase access to essential medicines, particularly in developing countries.
- Differential Pricing: This policy involves setting different prices for the same medicine in different countries or markets, based on their ability to pay. This can help to ensure that essential medicines remain affordable and accessible to those who need them most.
- Patent removal in certain regions. For example, the person who owned the crucial patent for a significant HIV medication called stavudine, convinced the company who licensed the patent, Bristol-Myers Squibb, to refrain from enforcing it in South Africa. This action resulted in a substantial decrease (up to 30 times) in the price of the drug and allowed for significant expansion of HIV treatment programs in South Africa. Sadly this case is almost unique.
- Public-Private Partnerships: This policy involves collaboration between the public and private sectors to develop and distribute essential medicines. This can help to increase access to essential medicines, particularly in developing countries where healthcare infrastructure may be limited. Public funding with no patent but incentives for private companies to produce the medicine.
- Alternative funding solutions such as Etica create an incentive without the need for policy fundamental policy change. It is an open-source protocol for medical research without intellectual property. It aims to create an alternative funding solution for medical research while removing patents. A true win-win solution with an incentive for innovative research. Researchers are financially rewarded throughout the process of research, removing the need for IP. All solutions found within Etica are immediately available for anyone to use without patent restrictions. Open Source has already proven to be faster and more efficient in many other fields like Software development and can fundamentally change how we do medical research.
While these policies and solutions have the potential to improve medicine accessibility, there are also potential limitations to consider. For example, compulsory licensing may discourage pharmaceutical companies from investing in research and development, as it reduces their potential profits. Patent pooling may also result in reduced incentives for innovation, as it reduces the potential financial rewards for patent holders. Differential pricing may also result in higher prices for those who can afford to pay, which can be seen as unfair. But overall all of these solutions would help save lives and make the world a fairer place.
In conclusion, the patent system for the medical field needs to be rethought, transformed, and improved to stop wasting public money and losing lives because of corporate and individual greed.
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Another paper that must be read, is very high quality, complete, and detailed. It is mentioned in all the other papers on the subject as a source: “Deadly gaps in the patent system : an analysis of current and alternative mechanisms for incentivising development of medical therapies.”
Also interesting: “Are Patents Really Necessary?”