The Vaccine Rush Versus the Rule of Law

 The Vaccine Rush Versus the Rule of Law

The past week has seen the mainstream media and certain wealthy countries lean into the ferocious frenzy fanned by Covid-19 vaccine patent waivers and “compulsory licensing”. When it comes to implementing such plans, the devil is, as always, in the details.

Vaccine distribution has been ramped up by the WHO and politicians around the world to reduce the pandemic’s impact and this is commendable. The idea of extending its reach by creating local “basins” to ensure widespread access to jabs worldwide is quite interesting.

But what is needed for patent waivers or “compulsory licensing” to be implemented practically in a comprehensive and effective fashion? Will they remain a pure abstraction?

Remember that the rules of law aims to provide clarity in social and economic relations. Furthermore, a patent is qualified essentially as an intellectual property right since it should be the result of a specific research effort made possible by a highly specialised  team of experts.

The law has produced the contractual scheme known as a “manufacturing license agreement” to regulate how a patented drug’s production rights are granted.

The proposed patent waiver does not seem to be the easiest solution. It has met resistance primarily because it would be viewed as an unacceptable means of putting IP laws on hold for an unspecified period of time.

Therefore, the idea of compulsory licensing appears to be gradually catching on in the international community.

According to article 31 of the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, a member state can order domestic manufacturers to make a patented product without permission from the patent holder, including in cases where a patent is pending approval.

The procedure first provides for a negotiation between the company applying for a license and the patent holder on a “voluntary basis”. However, if talks fail the applicant will eventually be allowed to make patented drugs for domestic purposes.

To save time in cases of “national emergencies” or for “other circumstances of extreme urgency”, this voluntary approach may be set aside to allow a compulsory process to take place.

In fact, “compulsory licensing” forces the patent holder to enter a contract — an exception to the general principle of contractual freedom.

Undeniably, when certain reasons of public interest arise, this dispensation on the general rules regarding the free consent between the parties rests on irreproachable bases.

Despite that, the bottom line here is not only forcing someone to stipulate, but figuring out the actual contents of the agreement the patent holder is forced to enter into, to make it possible to achieve the practical effects pursued by TRIPS art. 31.

Basically, in a medical context, the licensor shall transfer to the licensee all the data needed to manufacture the product, provided that the latter be willing to undergo the required checks by the former to meet the exact same scientific and technological standards.

However, how can the licensor be compelled to implement such checks? Who shall be in charge of making sure that such checks are carried out  appropriately?

We must not forget that the welfare of billions of people around the world is at stake as we are dealing with massive vaccination campaigns.

What would happen if the licensee is unable to produce the drugs because of a lack of industrial capacity or supply chain access? And who would be in charge to assess whether or not the licensee is professionally qualified to produce the vaccines?

On top of that, the major pharmaceutical companies have been testing and applying a new technology for the first time and have also been experiencing some difficulty obtaining the material required for its production.

To sum it all up, the risk is that the efforts made to implement a comprehensive vaccination policy might be jeopardised by a degree of abstraction shared by a large number of politicians around the world and ordinary people who seem to not grasp the relevant details.

Recalling the basic question of licensor compliance noted here, the discussions that we are treated to on the news do not seem to convey an idea of clarity and transparency which should always be the ultimate purpose of the rule of law.

Image credit: neelam279 under Pixabay licence.

Maurizio Gardenal

Maurizio Gardenal is a regular contributor to the NATO Defence College Foundation as editor of the column “Lawfare” and a member of its scientific committee. He is also an editor of the column “Observatory on international law” at “Il Sole 24 ore” and a member of the ABA and of the International Law Committee. His full biography and details are available at www.gardenal.it.

1 Comment

  • Very good and appropriate comments…

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