TRIPS & Public Health

Is there a stipulation for copying a patented drug?

- Based on this Article Country A could copy a patented drug from Country B assuming that as a developing country they cannot afford to import the patented drug from Country B but need this drug for the wellbeing of their citizens - However this Article also places a restriction on this saying that when copying a patented drug, the drug must be for domestic use primarily, which is why the lawyers of the Trade Minister of Country A may be telling Country A that exporting this generic to a very poor country is not possible.

Problem with stipulation

- During Doha, WTO member governments stressed that it is important to implement and interpret the TRIPS Agreement in a way that supports public health — by promoting both access to existing medicines and the creation of new medicines. -- They agreed that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. They underscored countries' ability to use the flexibilities that are built into the TRIPS Agreement, including compulsory licensing and parallel importing. And they agreed to extend exemptions on pharmaceutical patent protection for least-developed countries until 2016. - Problem: Article 31(f) of the TRIPS Agreement says products made under compulsory licensing must be "predominantly for the supply of the domestic market". -- *This applies to countries that can manufacture drugs — it limits the amount they can export when the drug is made under compulsory licence.* -- And it has an impact on countries unable to make medicines and therefore wanting to import generics. They would find it difficult to find countries that can supply them with drugs made under compulsory licensing.

3 waivers

- The legal problem for exporting countries was resolved when WTO members agreed on legal changes to make it easier for countries to import cheaper generics made under compulsory licensing if they are unable to manufacture the medicines themselves. - The decision contains three waivers 1. *Exporting countries' obligations under Article 31(f) are waived* — any member country can export generic pharmaceutical products made under compulsory licences to meet the needs of importing countries (but 23 developed countries voluntarily decided to not use it) 2. *Importing countries' obligations on remuneration to the patent holder under compulsory licensing are waived* to avoid double payment. Remuneration is only required on the export side. 3. *Exporting constraints are waived for developing and least-developed countries so that they can export within a regional trade agreement*, when at least half of the members were categorized as least- developed countries at the time of the decision. - That way, developing countries can make use of economies of scale.

Effects of the waiver

- These conditions aim to ensure that beneficiary countries can import the generics without undermining patent systems, particularly in rich countries. - They include measures to prevent the medicines from being diverted to the wrong markets. - And they require governments using the system to keep all other members informed, although WTO approval is not required. - At the same time phrases such as "reasonable measures within their means" and "proportionate to their administrative capacities" are included to prevent the conditions becoming burdensome and impractical for the importing countries.

AIDS epidemic example

- When the AIDS epidemic hit Africa, countries like India and Brazil were already able (because they had the plant - the capability to produce a generic) to copy them during the patent period - So they said we will help Africa and send cheaper medicine to deal with AIDS because the European and American medication under patent were too expensive - BUT the problem is that when you copy under Article 31 you copy for predominantly use in your own country, but Africa had zero production capability and now was unable to import from Brazil and India and they needed this medication.

This situation falls under the jurisdiction of the TRIPS Agreement (Annex 1C of the WTO Agreement), in particular under Article 31 "Other Use Without Authorization of the Right Holder". What does Article 31 allow?

- it allows *compulsory* licensing agreement (don't need consent of owner, vs voluntary license where you do), governments and third parties to use a patented subject matter (which is a document on which the invention is written and the right to use is limited to the inventor) without the owner's permission "in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use - i.e., it can skip the step of negotiating a voluntary license in order to save time - however, the patent holder must be promptly informed - and also the patent holder must be paid - The agreement allows compulsory licensing as part of the agreement's overall attempt to strike a balance between promoting access to existing drugs and promoting research and development into new drugs.

Does it have to be an emergency?

Not necessarily, 1. 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 2. 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". 3. It cannot be given exclusively to licensees (e.g. the patent-holder can continue to produce) 4. It should be subject to legal review in the country.

Waiver

Pressure to create an amendment - was not fully ratified so a waiver was in place in the meantime, this waiver said that in the case of exportation of medication to LDCs the exporter's (in this case Brazil and India) obligation was waived meaning they could export, with the condition that the LDCs could not re-export the medication for money.

Country A, developing country produces a generic drug by copying a patented drug from Country B. Country A would now like to export this generic to a very poor country, but the lawyers of the Trade Minister of Country A tell him it is not possible. Comment.

TRIPS - Trade-Related Aspects of Intellectual Property Rights https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm