Increasing Access to Medicines in Black Communities by Taking Advantage of Doha Flexibilities

There is no legitimate reason for anyone in America to go without affordable access to life saving medications. As an economic superpower, America supports foreign nations in their efforts to overcome terroristic takeovers as well as the effects of natural disasters and the onslaughts of poverty. However, they sit idle when it comes to addressing issues right here in their own backyard concerning Black Americans’ access to medicines. This is despite having the means and legal rights – which are outlined in the Doha declaration on the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement and Public Health of 2001 – to mitigate barriers associated with accessible medication.

The African American community has experienced long-standing, formidable injustices that have created distinguishable disparities in wealth distribution, health care accessibility and overall socioeconomic statuses when compared to White Americans. An accumulation of stressful lifetime events has been widely accepted as contributing to, for example, the higher prevalence of cardiovascular diseases in Blacks. Specifically, Blacks are more likely to die from heart-related diseases and stroke than Whites. Furthermore, young Blacks are twice as likely to have chronic diseases that commonly occur at later ages in Whites. Apart from the early onset of stress-related illnesses, Blacks are also dealing with the long-term effects of government complicity in infection and addiction in their community. , Historically, there has always had to be an amelioration of Black American rights in this country for racist practices that disproportionately affected them. Although systemic racism will take much more than awareness to be reconciled, the health crisis that exists in the Black community can be mitigated if the American government takes advantage of extant trade policy allowances.

Advocates of robust intellectual property rights (IPRs) argue that strong protections are critical for continued global innovation and economic growth. Opponents rebut this argument, stating that IPRs lead to unequal income and property distribution, favoring economic elites in wealthy nations and preventing equitable access of proven therapies to developing nations. This view, shared by many developing country World Trade Organization (WTO) members, prompted the signing of the Doha Declaration on the TRIPs Agreement and Public Health of 2001, which sought to rebalance global IP protection, providing a public health exception to the strict TRIPs requirements. The aim of the Doha Declaration was to address disparities in access to life-saving medications worldwide in respect to patent laws and pharmaceutical manufacturing capabilities of developing nations. Concern about how IRPs could limit developing countries’ response during a public health emergency provided the premise for this agreement.
The end result was the reaffirmation of TRIPs Agreement’s “flexibilities” allowing Members to approve less expensive versions of patented drugs.

The Doha Declaration reaffirms countries’ abilities to issue a compulsory license (CL) for a particular medication that is still under patent protection in their own market. It makes clear that countries may determine the grounds on which CLs are granted, and these grounds can include public health emergencies. A CL enables companies designated by the government to manufacture and distribute the patented drug at a lower price to mitigate the effects of a health crisis in their respective countries. By taking such liberties, patented inventions can be used without the patent holders’ consent. However, TRIPs does require the government issuing the CL to compensate the rights holder for the use of the protected product and the patent holders ultimately still retain ownership of their intellectual property.

The Doha Declaration also encourages WTO members to interpret and implement the TRIPS agreement in a manner that supports public health and particularly promotes access to medicines for all. The human rights infractions experienced by the Black community – stemming from the institutionalized social injustice of slavery, organized segregation and Jim Crow, ongoing police brutality, continued systemic government racism, current professional implicit biases and sustained socioeconomic hardships – are reason enough for the government to utilize the flexibilities allowed by the Doha Declaration to make medications treating stress-related conditions like heart disease and diabetes more affordable for Black Americans.

Since the signing of the Doha Declaration, a number of countries have taken advantage of compulsory licensing, including Indonesia and India. In America, march-in rights are very similar to CLs in that the transfer of intellectual data to a non-patent-holder can be initiated to increase accessibility of medicines to given populations during health crises. And, in fact, over the last 20 years, march-in rights have been part of several critical policy discussions in the United States.

To address racially unjust practices, laws like the Equal Employment Opportunity Act and Affirmative Action have been implemented to reverse discriminatory practices that have historically targeted the Black community. However, long-standing Procrustean agendas that contribute to the socioeconomic status of the Black population still must be addressed. Until this transpires, something more immediate needs to be done. Either the American government eliminates the need for march-in rights by addressing the impact of systemic race-related practices that cause health perturbations in the Black community – or it could utilize march-in rights to make medicines more affordable for the stress-related illnesses that are indicative of being Black in America.

The racial battle fatigue the Black community has endured is further aggravated by socio-determinants of health that have contributed to the detriment of the population’s overall well-being. Health care disparities are only part of an overall cumulative effect on the health of Black Americans. Medical conditions then become compounded by unaffordable medication. The branded pharmaceutical industry asserts commercial value incentivizes innovation and stripping intellectual rights from inventors should only be used as a last resort to ensure equitable access to medicines. But the unwillingness of COVID-19 vaccine producers to support CL for their vaccines proves that their position is weak. There is no stronger example of a global public health emergency than the COVID pandemic, yet the branded pharmaceutical industry still doesn’t believe this qualifies as a situation warranting the use of CLs. If it won’t support a CL in this situation, will it ever voluntarily offer America’s Black patients sustainable access to needed medicines without direct government intervention?

Compiled research demonstrates that implementation of CL to procure affordable drugs has positive effects on the economy, public health and even foreign investment with no impact on future patent application trends. However, the U.S. government has not acted to leverage the flexibilities allowed by the TRIPs Agreement and reaffirmed by the Doha Declaration to ensure that Black Americans have access to the medicines they need, even though officials have supported a proposed TRIPs waiver to ensure patients in other countries have access to COVID vaccines. The American Medical Association acknowledged that racism is a threat to public health and “without systemic and structural-level change, health inequities will continue to exist.” Assuredly, the Black community is in a public health emergency and Doha provides the path to ensure that equitable access to medicines extends to this marginalized population. Now is the time to start considering last-resort actions like exercising march-in rights in the Black community so that there is affordable access to drugs that improve quality of life.



About the Author