The Specter of Compulsory Licensing Haunts Vaccine Debate

June 11, 2020

Volume 40, Issue 6

Industry prospects at mercy of public discourse, policy shifts.

Paul Hudson’s observation in mid-May that you get the vaccines that you pay for could hardly have come at a worse time for a pharmaceutical industry struggling to hold the line against patent rights erosion. At any other time, the Sanofi CEO’s reminder that those who fund research and development are entitled to expect a return might have passed without much comment. It would have been seen perhaps as no more than a statement of an

unfortunate, uncomfortable, but unavoidable fact of life.

But not at this particular moment, with the chronic European concerns about access to medicines inflamed by acute anxiety over who will get treated with an eventual vaccine against COVID-19-and who will not. So Hudson was denounced left, right, and center-quite literally. European accusations of high treason greeted the suggestion by the boss of a largely European company that it would be the US that deserved first claim on a vaccine produced with a hefty dose of US money. Europeans are not only fearful of their own vulnerability in the face of coronavirus; they are also loud in their insistence that everyone in the whole world should benefit from a vaccine. 

French President Emmanuel Macron, who has been at the forefront of calls for universal access to any vaccine, summoned the errant boss of what is France’s biggest hitter in the international drug market. Hudson attempted to contextualize his controversial remarks by telling everyone who would listen,“We need to get this vaccine to everybody,” promising not to stop “until everyone gets what they need around the world.” But his recantation came too late. The wheels of policy had already started to grind away at intellectual property before he shot to pariah prominence, and his intervention did little more than cause them to spin a little faster.

What Hudson did do was to provide an easy target, as a bad guy clearly identified and prominently displayed for all to see and vilify, in a complex debate that was underway in Europe-and international bodies such as WHO and even the UN-over distributing and paying for a vaccine. The debate had been driven in large part by altruism or a sense of social responsibility and solidarity, but Hudson’s remarks unleashed a wave of resentment about the pharmaceutical industry, already caricatured by some campaigners as readying itself for predatory exploitation of the pandemic. 

Since then, determination to avoid the richest bidder winning the prize of the first vaccine has dominated public discourse. European Commission Vice President Margaritis Schinas told the European Parliament just days later that “bold steps together are needed” to deliver a vaccine that will be accessible and affordable and equitable worldwide. That debate featured calls from across the political spectrum for easy universal access, and for policy changes to make that happen. The obstacle that IP might present to such universal access has become a central element in the broader European discussions, with growing enthusiasm for compulsory licensing across swathes of the population that until a few weeks ago were blissfully ignorant of the minutiae of the international trade agreements on patents. 

The most remarkable feature of this conversion to compulsory licensing has been a switch in the position of the center-right European People’s Party (EPP), the largest political group in the Parliament. “It is legally possible to go for so-called forced or compulsory licencing. This makes it possible for member states to use the recipe for the vaccine production without formal consent of the original patent holder,” announced the EPP’s principal health mouthpiece, German physician Peter Liese, with the full backing of his group. Until now, the EPP has been a staunch defender of the interests of the pharmaceutical industry-notably in attempting (unsuccessfully) last year to resist weakening of EU protection against generic products in Europe. The shift presents the European drug industry with a new problem at a sensitive moment.

The official position from the main European drug lobby, the European Federation of Pharmaceutical Industries and Associations (EFPIA), has been to endorse the principle of wide access to a vaccine-but it has conspicuously avoided detailed discussion of how this should be achieved. Now, with compulsory licensing firmly on the table, coupled with the defection of its main ally in EU policymaking, EFPIA may find it can no longer dodge some difficult questions about just how far it is ready to break the habit of a lifetime on the scale that COVID-19 will require. 

 

Reflector is Pharmaceutical Executive’s correspondent in Brussels

download issueDownload Issue : Pharmaceutical Executive-06-01-2020