The medical establishment often struggles with the issue of vaccines in relation to intellectual property rights.
Supporters of intellectual property rights for vaccines argue that these rights promote investment into the manufacturing of vaccines, improving long-term vaccine development and thus global health.
On the other hand, critics claim that intellectual property rights for vaccines prevent the mobilization of additional vaccine manufacturers. This lack of mobilization would in turn cause many suffering from a lack of access to vaccines to contract or even die from a vaccine-preventable disease.
Intellectual Property Rights for Vaccines
Vaccines and related technologies may benefit from any of several different intellectual property rights. These rights include those related to patents, data protection, trademarks, copyrights, and trade secrets. Patents for vaccines are usually related to the formulation of the vaccine. Some patents may also exist to cover the device used to administer the vaccine. Data protection for clinical tests denies most third parties the right to use clinical trial data. Without this restriction, third parties might use the data to attempt to obtain marketing approval for the manufacture of competing products.
Copyrights guard the expression of ideas. In relation to vaccines, they can be applied to explanatory materials and designs used for the vaccines. Trademarks, which establish a connection between a product or service and the individual or organization which provides it, protect a vaccine’s brand name. Trade secrets are forms of intellectual property which protect unpublished, non-patentable, or non-codifiable knowledge. Trade secrets for vaccines are generally related to knowledge regarding the manufacturing process of the vaccines.
The Case for Intellectual Property Rights for Vaccines (Case Study #1: The Hepatitis B Vaccine)
Those who support the use of intellectual property rights to protect vaccines have cited several points to strengthen their stance. The most important point in favour of intellectual property rights for vaccines is that of investment. The investment generated by way of intellectual property rights allows researchers and scientists to ramp up research and development. This accelerated research and development will allow pharmaceutical companies to produce effective and safe vaccines more rapidly. Supposedly, by enabling the distribution of vaccines, the use of intellectual property rights for vaccines can prevent much suffering and death.
Supporters also claim that intellectual property rights for vaccines facilitate cooperation. Many pharmaceutical companies provide vaccines for all manner of illnesses. However, the almost endless list of diseases in this world means that no single vaccine provider could possibly supply all the vaccines needed. Without intellectual property rights, many companies providing vaccines might be reluctant to work with other entities to improve global health. However, when their proprietary vaccine technology is protected, they will be more willing to do so because they will know that their rights are not being infringed.
The hepatitis B vaccine is a valid example of how intellectual property rights for vaccines are beneficial. In 1981, Merck & Co was the world’s only provider of the hepatitis B vaccine. This vaccine cost around US$30 at the time. As the years passed, intellectual property rights were provided to other manufacturers of hepatitis B vaccines. By 1999, even after adjusting for inflation, the price of a hepatitis B vaccine was around US$0.50, making it far more accessible for people all over the world.
The Case Against Intellectual Property Rights for Vaccines (Case Study #2: The Ebola Vaccine)
Those who oppose intellectual property rights for vaccines have stated that these rights cause vaccines to remain concentrated in more developed countries. The primary intellectual property holders of such vaccines are based in these countries. They usually sell most of their available vaccine doses to their respective home countries as well as those of other high-income countries. The profit-based model of intellectual property rights regimes facilitates such an approach; however, this approach reduces the access to vaccines which less well-off countries receive.
Governments of less affluent countries tend to oppose intellectual property rights for vaccines. This is because they desire the right to develop and produce their own vaccines. If they were to do so, they would be unburdened by the concern that they would be sued by a patent holder. The entry of manufacturers from these countries into the field would enable the people in less-developed countries to obtain greater access to vaccines.
The events associated with the Ebola vaccine are sometimes cited by opponents of intellectual property rights for vaccines. The development of an Ebola vaccine was delayed because of a lack of a foreseeable market for the vaccine. Therefore, there was no incentive for companies to spend money on vaccine research and development. This cost many their lives. Without the restrictions imposed by intellectual property rights, such a vaccine might have come about due to the greater degree of accessibility which would have existed; many lives may have been saved.
This article is brought to you by Exy Intellectual Property Malaysia and Singapore.