Who Owns Medicines during Pandemics? Reading the Global Situation from a Different Angle

Lack of access to medicines is a public health challenge all over the world;  a challenge which is further compounded during global crises. Currently, the world is racing to find an effective treatment for COVID-19. Every country will doubtlessly seek to provide its patients with the drug, once identified, but will they all be able to? The landscape is rapidly shifting: before COVID-19 cases began to spike, even before the World Health Organization (WHO) declared it a pandemic, some countries decided to restrict, or ban altogether, the export of pharmaceutical drugs. The UK barred the export of 80 drugs used for patients in intensive care (UK Government, 2020). India made a similar decision, prohibiting the export of 26 pharmaceuticals, including paracetamol, although it recently backtracked under pressure from the US government. Since India produces about one-quarter of the active pharmaceutical ingredients (APIs) used to manufacture generic drugs around the world, restricting exports is likely to affect global availability (Dasgupta, 2020; BBC, 2020).

Who owns the medicine? 

Intellectual property rights (IPRs), primarily patents, are a main driver of pharmaceutical companies’ search for new drugs. Patents give their holders exclusive market rights for years, thus ensuring massive profits. There are now rising concerns that IPRs would constitute a barrier to access to COVID-19 treatment. IPRs comprise binding obligations to all members of the World Trade Organization under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), although the Agreement includes measures and flexibilities aimed at protecting public health. These rights were further emphasized by the 2001 Doha Declaration on the TRIPS Agreement and Public Health. Pharmaceutical patents are granted for 20 years, after which the drug falls into the public domain, meaning that any company can produce it. After a patent expires, typically several generic versions of the drug appear on the market, which are usually cheaper and therefore more widely available.

The TRIPS Agreement includes exceptions and flexibilities to protect the right of patients to access medicines in cases of exploitative practices by the patent holder, such as price gouging. In Egypt, Law 82/2002 on the Protection of Intellectual Property Rights devotes ample space to flexibilities, detailing the cases in which they apply, to ensure that IPRs do not threaten public health in Egypt in case of a patent-holder’s monopoly on medicine.

What about a treatment for COVID-19?

Clinical trials are currently underway for an effective treatment of COVID-19 using existing pharmaceutical products—a process known as repositioning or repurposing, which means using an existing drug for a new therapeutic purpose (Rose & Santos, 2020). Among these is remdesivir; a broad-spectrum antiviral produced by the American company Gilead Sciences, and is being tested as part of the international clinical trial “Solidarity” adopted by the WHO in 70 countries (WHO, 2020). To date, study results show in vitro efficacy for remdesivir administered with chloroquine, that is, in a laboratory setting (Wang et al., 2020). 

Remdesivir is patented in several countries, including China and India, which allows the producer to monopolize the production and marketing of the drug in these countries until the patent protection expires. Remdesivir is not registered by the Egyptian Drug Authority (EDA), according to the online database on the EDA website. In the meantime, a patent application for remdesivir has been submitted to the Egyptian Patent Office, and is currently under examination.

Another promising drug is favipiravir, known by the commercial name Avigan, produced by the Japanese FUJIFILM Toyama Chemical, it is an antiviral medicine which has been tested on patients in Wuhan and Shenzhen. In Shenzhen, it reduced the time required for viral clearance from 11 to 4 days on average (Qingxian et al., 2020). Favipiravir is also patented in several countries, including India and South Africa. Its patent application is currently under examination at the Egyptian Patent Office and is not currently included in the EDA’s database of registered medicines. Trials are also being conducted for other drugs, most importantly lopinavir/ritonavir combination, also included in the WHO Solidarity clinical trial. Published results to date have been inconclusive about its efficacy (Cao et al., 2020; Lim et al., 2020).

Lopinavir/ritonavir, known commercially as Kaletra, is used to treat HIV/AIDS. The patent is held by the US firm AbbVie and is one of their key products, netting them $283 million in sales in 2019 alone (AbbVie, 2020). India is currently producing a generic, low-cost version of lopinavir/ritonavir after its patent expired. The drug is not patented in Egypt, meaning there is no impediment to its local production.

Global action to prevent monopolies and protect health

As governments and researchers around the world have come to realise that drug patents could hinder access to medicines at this critical time, calls were made for the use of the flexibilities available under the TRIPS Agreement, proposing that patents for potential therapies for the novel coronavirus be suspended to enable their use in clinical trials and patient treatment.

In response, the Medicines Patent Pool (MPP), a project run by the International Drug Purchase Facility (UNITAID), which is overseen by the WHO,[i] decided to expand its mandate to include drugs that could be used to address COVID-19. The MPP’s scope of operation originally covers drugs for hepatitis C, tuberculosis, and HIV (MPP, 2020). In an unusual step, AbbVie voluntarily waived its rights to opinavir/itonavir, thereby making it available for use in clinical trials or for treatment.

Are all COVID-19 drugs patented?

The challenge is that many of the drugs listed above are still patented in several countries, raising questions about licensing and pricing. A study examining the production cost of pharmaceutical treatments for COVID-19 that have been tested so far found that it would cost between $0.30 and $31 per treatment course per patient, depending on the drug; producing a one-day dose of remdesivir and favipiravir costs $0.93 and $1.45 respectively (Hill et al., 2020). Currently, the listed prices of these drugs are much higher (inclusive of a profit margin for the companies).

There are also drugs in the public domain whose effectiveness is currently being tested. These include chloroquine and hydroxycholorquine, both available worldwide in generic versions. Both are currently being tested as possible COVID-19 treatments. One clinical trial in France, though on a small sample of patients, found that hydroxycholorquine was effective in combination with azithromycin (Gautret et al., 2020).

Access to medicines and tradeoffs

The current global crisis urges us to reconsider the international IPRs regime. Article 7 of the TRIPS Agreement refers to “social and economic welfare” and “a balance of rights and obligations” as objectives of IPRs protection and enforcement. In the case of COVID-19, treatment and vaccines are still being tested, but global discourse is clearly wary of patents as a possible impediment to accessing medicines that would prove to be efficacious in clinical trials.

In Egypt, at the time of writing, it is very likely that IPRs will not be a stumbling block given the lack of patent protection for all above-mentioned medicines. Nevertheless, patents are not the sole obstacle to accessing medicines. In Egypt, pharmaceutical production relies largely on imported APIs. Should the need arise for a new drug, Egypt would have to import its API in the midst of a global crisis. In addition, any new drug must be registered by the EDA before hitting the market, to ensure it meets the criteria of quality, safety, and efficacy. The registration process itself at times constitutes a procedural barrier to making medicines readily available, according to pharmaceutical manufacturers in Egypt. Both local and international situations continue to be fluid, with no conclusive answers to questions being raised at the moment.

[i] The MPP was created to facilitate licenses for the production of certain drugs between patent holders and  companies seeking to produce generic versions of the drugs.

References

• (2020, February). AbbVie reports full-year and fourth-quarter 2019 financial results.

• (2020, March). Coronavirus: Drug shortage fears as India limits exports. BBC.

• Cao, B., Wang, Y., Wen, D., Liu, W., Wang, J., Fan, G. … Wang, C. (2020). A trial of lopinavir–ritonavir in adults hospitalized with severe Covid-19. The New England Journal of Medicine.

• Dasgupta, N. (2020). India likely to soon ease some drug export curbs after U.S. pressure. Reuters.

• Gautret, P., Lagier, J. C., Parolam, P., Hoang, V., Meddeb, L., Mailhe, M. … Raoult, D. (2020). Hydroxychloroquine and azithromycin as a treatment of COVID-19: Results of an open-label non-randomised clinical trial. International Journal of Antimicrobial Agents.

• Hill, A. Wang, J. Levi, J. Heath, K., & Fortunak, J. (2020). Minimum costs to manufacture new treatments for COVID-19. Journal of Virus Eradication.

• Lim, J., Jeon, S., Shin, H. Y., Kim, M. J., Seong, Y. M., Lee, WJ. … Park, S. J. (2020). Case of the index patient who caused tertiary transmission of coronavirus disease 2019 in Korea: The application of lopinavir/ritonavir for the treatment of COVID-19 pneumonia monitored by quantitative RT-PCR.J Korean Med Sci.

• Medicines Patent Pool. (2020, April). The Medicines Patent Pool and Unitaid respond to access efforts for COVID-19 treatments and technologies.

• Qingxian, C., Yang, M., Liu, D., Chen, J., Shu, D., Xia, J. … Liu, L. (2020). Experimental treatment with favipiravir for COVID-19: an open-label control study. Engineering.

• Rosa, S. G. V., & Santos, W. C. (2020). Clinical trials on drug repositioning for COVID-19 treatment. Rev Panam Salud Publica.

• UK Government. (2020). Crucial medicines protected for coronavirus (COVID-19) patients.

• Wang, M., Cao, R., Zhang, L., Yang, X., Liu, J., Xu, M. … Xiao, G. (2020). Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Research, 30, 269–271.

• World Health Organization (WHO). (2020). “Solidarity” clinical trial for COVID-19 treatments.

• World Trade Organization (WTO). TRIPS Part I: General provisions and basic principles.