Here is how the G7 governments must deal with Gilead:
Compulsory licensing of pharmaceuticals and TRIPS
Here are some extracts from www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm
(the underlines are mine)
What is compulsory licensing?
Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner. It is one of the flexibilities on patent protection included in the WTO’s agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.
Does there have to be an emergency?
Not necessarily. This is a common misunderstanding. The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licences
The TRIPS Agreement does list a number of conditions for issuing compulsory licences, in Article 31. In particular:
* normally the person or company applying for a licence has to have tried to negotiate a voluntary licence with the patent holder on reasonable commercial terms
. Only if that fails can a compulsory licence be issued, and
* even when a compulsory licence has been issued, the patent owner has to receive payment; the TRIPS Agreement says “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”, but it does not define “adequate remuneration” or “economic value”.
You said “normally” …
Yes, this is where the confusion about emergencies arises. For “national emergencies”, “other circumstances of extreme urgency” or “public non-commercial use” (or “government use”) or anti-competitive practices
, there is no need to try first for a voluntary licence. It’s the only instance when the TRIPS Agreement specifically links emergencies to compulsory licensing: the purpose is to say that the first step of negotiating a voluntary licence can be bypassed in order to save time. But the patent owner still has to be paid.
Who decides whether the payment is “adequate”?
The authorities in the country concerned. The TRIPS Agreement says the patent owner must be given the right to appeal in that country as well.
The Doha Declaration
(extracts from: www.wto.org/english/tratop_e/trips_e/healthdeclexpln_e.htm
The special declaration responds to these concerns in a number of ways.
First, it emphasizes that the TRIPS Agreement does not and should not prevent WTO members governments from taking measures to protect public health
. It reaffirms the members’ rights to use fully the provisions of the TRIPS Agreement, which provide flexibility for this purpose.
Second, the declaration makes it clear that the TRIPS Agreement should be interpreted and implemented in a manner that supports WTO members’ right to protect public health and, in particular, to promote access to medicines for all.
Third, the declaration contains a number of important clarifications of some of the flexibilities contained in the TRIPS Agreement. It does this while maintaining members’ commitments under the TRIPS Agreement.
On compulsory licensing, the declaration makes it clear that each member is free to determine the grounds upon which the licences are granted.
This, for example, is a useful corrective to the view sometimes expressed that some form of emergency is a pre condition for compulsory licensing.
The TRIPS Agreement does refer to national emergencies or other circumstances of extreme urgency in connection with compulsory licensing. But this is only to indicate that in these circumstances there is no need to try to obtain a voluntary licence before resorting to compulsory licensing.
The declaration makes it clear that each member has the right to determine what constitutes a national emergency or other circumstance of extreme urgency
, and that public health crises can fit the bill, including HIV/AIDS, tuberculosis, malaria and other epidemics
The declaration also refers to the “exhaustion” of intellectual property rights
, and therefore a member’s right to allow parallel imports
(for an explanation see fact sheet.
The TRIPS Agreement says that a member government’s practices in this area cannot be challenged under the WTO dispute settlement system.
The declaration makes it clear that the TRIPS Agreement’s provisions on exhaustion in effect leave each member free to establish its own regime without challenge — subject to the general TRIPS provisions prohibiting discrimination on the basis of a person’s nationality.
So the TRIPS agreement leaves lot's of flexibility for member governments to deal with medical crises.
What makes Compulsory Licensing a legal power that western governments are so afraid to use, even when thousands of their citizens are dying from one of the world's most deadly diseases?
(and before anyone objects that technically hepatitis C is not an epidemic, it goes without saying that it is a pandemic, which is worse)
But let's also not forget that Gilead's tiered pricing and nation-based market segmentation practices
(see the clauses in Gilead's "Voluntary Licence" that relate to "territories") are clearly discriminatory to different nationalities.
In other words, the American company called "Gilead" is violating TRIPS left, right and centre!