E-News No.45

E-News No.45

The increasing importance of Article 39.3 TRIPs by Adarsh Ramanujan, R. Parthasarathy, Malathi Lakshmikumaran (Lakshmikumaran & Sridharan – Switzerland, India)

There is an increasing global momentum towards having access to clinical data of pharmaceutical substances and this raises the significance of Article 39.3 of the TRIPs Agreement.

For instance, the European Medical Agency (EMA) has been sharing information with anyone who makes a request under its 2010 Policy No. 00030. Under its new 2014 Policy No. 00070, the EMA will proactively publish clinical trial data and access is regulated through an online portal. It would appear that barring certain specific portions, information on the safety / efficacy of an approved drug is not considered confidential per se and therefore, disclosable.

In its second sentence, Article 39.3, TRIPs, allows for the disclosure of clinical data “where necessary to protect the public or … steps are taken to ensure that the data are protected against unfair commercial use”. The presence of the word ‘or’ suggests that these are alternative exceptions and fulfilling even one of them would be sufficient. EMA Policy No. 00070, for instance, expressly states that proactively making available clinical data will “promote better-informed use of medicines” and “benefit public health in future” because it will allow “all medicine developers to learn from past successes and failures”, “enable the wider scientific community … to develop new knowledge”. If the disclosure is, therefore, considered as being “necessary” to protect the public, there is no violation of Article 39.3, TRIPs.

Regulatory agencies in many jurisdictions often accept clinical data from other jurisdictions (completely or partially) and many may not explicitly prevent one applicant from providing data pertaining to another. Therefore, a competitor may obtain clinical data legally from, say, the EMA, and use that data to seek regulatory approvals in other jurisdictions. In its 2014 policy, the EMA has created a binding and enforceable (in the UK) contract with its users that obtained information cannot be used to support drug approval applications anywhere in the world. Practical enforceability of this mechanism aside, a similar binding prohibition or restriction is not applicable under the earlier 2010 Policy and the EMA has also specifically clarified that this earlier policy continues to apply.

These developments raise several important questions on Article 39.3, TRIPs:

(i) In the context of other WTO Agreements, the Appellate Body of the WTO has clarified that assessing the necessity of a measure is not a straight-jacket formula, but involves the weighing and balancing of several factors, such as the importance of the interests or values to be protected and the contribution of the measure to the realization of the objectives pursued by it. How far would one be able to justify the necessity of such transparency measures? In particular, would it survive if no mechanism in put in place to prevent the use of the obtained information to seek marketing approval in other jurisdictions?

(ii) Alternatively, could such transparency measures be justified under the second exception – that safeguards have been put in place to prevent “unfair commercial use”? This brings into focus the meaning of “unfair commercial use” – whether use of one company’s data to support the marketing approval of another is “unfair commercial use” in every case or should certain thresholds be crossed for it to become “unfair”? It also brings into focus a matter of territoriality – is a WTO Member required to place safeguards to prevent “unfair commercial use” only in their jurisdictions or elsewhere as well?

There are no immediate (or easy) answers to such questions, especially due to the lack of any authoritative interpretation of Article 39.3. Nonetheless, recognizing them and attempting to objectively sort through them would certainly be crucial first steps.