Access to Medicines 101

Being involved with the Access to Medicines movement has been a defining factor of my college experience and if you follow me on instagram or know me in person, you know I never stop talking about UAEM (Universities Allied for Essential Medicines) and all the opportunities I have been afforded in the access to medicines space because of this organization.

Along with two of my other amazing board members at the UAEM UCLA chapter, Rhea Shetty and Sapna Ramappa, we have created a short guide to some of the intimidating jargon that comes with this work. You’ve probably heard a lot of these words: patents, march-in rights, licensing, but why do they matter and how do they all fit together? Keep in mind, this is a very simplified version, but I hope it makes these technical nuances a little less scary. Especially with COVID-19, this movement is more relevant than ever. Here’s a little crash course:

What is a patent?

A patent is a right granted to an inventor by the federal government, that permits the inventor the rights to the intellectual property of the invention. This effectively works to exclude others from making, selling or using the invention for a certain period of time.

Who can grant patents?

Congress holds the power to grant patents under the Intellectual Property Clause of the Constitution.

How long do drug patents usually last?

20 years, but there are many legal techniques to prolong a drug patent that pharmaceutical manufacturers can take (ex: evergreening).

March-in Rights

What is the Bayh-Dole Act?

Enacted in 1982, the Bayh-Dole Act set a universal patent policy for federal agencies that fund research. This enables small businesses, non-profits, and universities to lay claim to inventions created under federally-funded research programs.

Major Provisions of the Act Include (https://autm.net/about-tech-transfer/advocacy/legislation/bayh-dole-act):

• Non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programs

• Universities are encouraged to collaborate with commercial concerns to promote the utilization of inventions arising from federal funding

• Universities are expected to file patents on inventions they elect to own

• Universities are expected to give licensing preference to small businesses

• The government retains a non-exclusive license to practice the patent throughout the world

• The government retains march-in rights in very specific circumstances

So this begs the question: what are March-in Rights?

Rights that allow the government to intervene and force the party with title to government-funded intellectual property to grant licensing to a different group/entity.

Why are they important/relevant?

March-in rights can be used federally to address health and safety needs that aren't being taken into account or being satisfied, or when the public is not being given reasonable access to the benefits of a patent. For example, Knowledge Ecology International (KEI) requested for the federal government to use its march-in rights to force the patent holder to grant licenses under reasonable terms on Xtandi, a life-saving prostate cancer drug, which costed $129,000 per year. Lower pricing for Xtandi would have significantly reduced out of pocket costs for patients and allowed insurers to remove the drugs from restrictive formularies that limit access. This request was denied by the National Institutes of Health (NIH), citing the lack of a shortage of Xtandi as justification.

Why is it so rare/why has the government, to date, not utilized March-in Rights?

Government intervention of this sort could undermine America’s innovation ecosystem and likely lead to the devaluation of patents.

Exclusive vs. Non-exclusive licensing:

An exclusive license, as the name suggests, enables the licensee to use the intellectual property (IP) in its entirety. Simply put, no one else including the licensor (the group granting the license) is able to use this intellectual property in the license unless otherwise mentioned. Non-exclusive licenses, however, give licensee rights for the intellectual property, but the licensor is able to give licenses to other groups as well. For this reason, non-exclusive licenses entail more competition as other licensees can use the intellectual property as well.

With regards to the drug development pipeline and the Access to Medicines movement, non-exclusive licenses essentially pave the way for greater access to the intellectual property: the medications themselves. Though exclusive licenses may seem more appealing for the licensee as it grants the licensee the ability to commercialize the drug developed, pharmaceutical companies historically use exclusive licenses to maintain a monopoly over the IP. This inevitably leads to price gouging, in which pharmaceutical companies establish exorbitant prices for medications. Under non-exclusive licenses, entities in other countries, for example, could create generic brands of these medications, thus creating competition and effectively lowering the drug prices when it enters the market.

How can people get involved?

• Join your local Universities Allied for Essential Medicines (UAEM) chapter (https://www.uaem.org/)

• If you are interested in getting involved with this movement, follow along and support https://freethevaccine.org/ where campaign participants are working to ensure that publicly-funded diagnostic tools, treatment, and the COVID-19 vaccine will be sustainably priced, available to all and free at the point-of-delivery (you can apply to join too by TODAY, September 6th).

• Join efforts to improve UAEM’s University Mapping Tool (https://www.publicmeds4covid.org/) which highlights key research universities and institutions that are receiving taxpayer money to develop novel diagnostics, therapeutics, and/or vaccines for COVID-19 in an effort to hold these institutions accountable - contact me for more information!

It is a sad truth but global health is not held as a fundamental human right, but rather, as a commodity sold to the highest bidder. If you are interested in getting involved with the Access to Medicines movement or have any questions, do not hesitate to reach out!