Pharmaceutical Patents: A Challenge for Malaysia

There was an article that examine the market for generic medicines in the Malaysia, following the introduction of the first generic patent in 2010 and the introduction of generic patent law in 2012. The paper was presented at the International Conference on Pharmaceutical Research and Development (IPRDC) in Kuala Lumpur, Malaysia, in June 2017.

NOTE: How do patents impact the availability of affordable medications in Malaysia? Dive into the complexities surrounding pharmaceutical patents and discover how these challenges influence the generic drugs market. Together, let’s explore the balancing act between innovation and accessibility in Malaysia’s healthcare landscape. Get a deeper look here.

There are some countries in the world that do not require waiting for patent expiration to produce a generic version of a drug. These countries, known as "compulsory licensing" countries, have laws that allow the government to issue licenses to local companies to produce generic versions of patented drugs without the patent holder's permission. Some examples of compulsory licensing countries include India, Brazil, and South Africa. 

However, these countries still need to comply with international agreements such as the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) when issuing compulsory licenses.

While India and Italy are known for their active pharmaceutical ingredient (API) industries and production of generic drugs, other countries such as Brazil, Canada, South Korea, and others also have provisions for the manufacture and sale of generic drugs before the patent expires. These countries have implemented different policies and regulations to facilitate the production and distribution of generic drugs while still upholding intellectual property rights.

It is noteworthy that Malaysia has a pharmaceutical manufacturing sector that almost exclusively produces generic drugs, with sales revenues amounting to only 1.5% of gross domestic product (GDP).

I also note that the five largest companies typically sell originator drugs and account for 47 percent of total drug imports. Moreover, the average cost of importing a generic drug in Malaysia ($1,000 to $2,500) is 87 percent higher than revenue.

It is worth mentioning that the government is the largest pharmaceutical buyer in Malaysia, responsible for more than half of the pharmaceutical purchasing value.

I am aware that while local manufacturers can produce medicines in all categories of medicines that are on the list of essential medicines, imports, especially high-quality medicines, are necessary to meet domestic demand.

I have learned that Malaysian manufacturers are now increasing their investment in research and development to produce higher value-added products such as pharmaceuticals, medical devices, and medical devices.

The market for medicines in Malaysia is divided between private clinics, private clinics, and pharmacies. However, the public health system's job is to provide the needy with medicines at near-zero cost, which avoids end-sales, that is, price increases.

Pharmaceutical experts have spoken about four aspects that generic manufacturers must take into account when purchasing active pharmaceutical ingredients, such as cost, quality, availability, quality control, and safety.

According to Zion Market Research, the global generic market is growing at more than 10 percent per year and is expected to reach approximately $380 billion by 2021. This growth is reflected in improved public health and lower prices for consumers, as well as higher sales of generic medicines.

In summary, a generic is a brand name medicine with a specific purpose, such as to treat a disease or medical condition. However, I recognize that problems related to pharmaceutical patents continue to pose a challenge for Malaysia.

I understand that in developing countries, citizens can usually trust that the medicines on pharmacy shelves are safe, authentic, and effective. However, they face increasing competition from foreign generic drug suppliers, which have established themselves in the market for public tenders. Indian and Chinese companies that produce high-quality generic medicines and export them around the world are competing.

Most families and doctors will probably opt for quality-guaranteed generics that are tested for bioequivalence, systematically tested for side effects, manufactured, and marketed well in comparison to brand-name competitors.

For example, non-branded generics account for more than 40% of the total US pharmaceutical market in the United States and more than 50% in the United Kingdom.

I find it interesting that the Malaysian government is the largest pharmaceutical buyer in the country, responsible for more than half of the pharmaceutical purchasing value. Local manufacturers are also producing medicines in all categories of medicines that are on the list of essential medicines, but imports, especially high-quality medicines, are still necessary to meet domestic demand.

It is good to know that Malaysian manufacturers are now investing more in research and development and producing higher value-added products.

However, the problems related to pharmaceutical patents still pose a challenge for Malaysia. Indian generic drug manufacturers have also been playing a dominant role in the Malaysian market, following the accelerated approval process agreed by the governments of the two countries.

As the global generic market is growing at more than 10 percent per year, I believe it is a positive trend for public health and lower prices for consumers, as well as higher sales of generic medicines.

It is interesting to learn that most families and doctors will probably opt for quality - guaranteed generics that are tested for bioequivalence, systematically tested for side effects, manufactured, and marketed well - in comparison to brand-name competitors. This is true for both developed and developing countries.

It is clear that Malaysia's 32 million people currently spend a significant amount on healthcare, with an average of $375 per year, about 75% of which is spent on medicines. I believe it is important to take measures to increase the availability of generics in high-priced patented forms, especially for life-saving medicines such as the anti-HIV drug nivolumab.

As per capita income rises, Malaysians spend more disposable income on pharmaceuticals. It is unfortunate that foreign pharmaceutical companies' products are not usually manufactured in Malaysia, and most brand-name drugs such as antiretroviral and cancer drugs are sold in other countries. Nonetheless, I hope that the Malaysian government will continue to encourage the pharmaceutical industry to grow and promote the use of generic drugs to improve public health outcomes.