Better be safe than sorry: should the regulation on patent compulsory licensing for exportation be reconsidered?

by Giancarlo Moretti

The spreading of Ebola across the western part of Africa has raised a number of questions and preoccupations on the current sanitary situation all over the world. Border and custom authorities of each country are implementing a high number of controls, in order to avoid any further contagion in other zones. Beyond this aspect, in legal terms, the current situation deserves attention in relation to the future challenges that some countries may have to face in the future.

Ebola has been recently classified by the European Medicine Agency as an orphan disease, in order to stimulate and incentivise research and to find an effective drug to fight it.[1] Albeit the most part of these researches are at the clinical trial stage, the next steps should be carefully planned. In particular, in case they would receive the marketing approval, how might these drugs be distributed?

The countries predominantly affected by this epidemic are least-developed countries, whose pharmaceutical industries have not been developed yet, even at a preliminary stage. In fact, their generic pharmaceutical industries have not been fully installed and their capacity to sustain the production of large quantities of drugs may constitute a serious hurdle to overcome. Hence, in such a context, as for the patents related to these classes of pharmaceutical goods, it is likely that developed countries or countries with an adequate level of pharmaceutical infrastructure (e.g. India) might be required to utilise compulsory licences for the purposes of exportation. However, international legislation allows only limited scope in order to adopt such types of measures.

In fact, the adoption of TRIPS Article 31bis is still pending[2] and, hence, the only tool available is the WTO Decision of 30 August 2003.[3] Several countries have adopted dedicated pieces of legislation, among which India[4], European Union (EU)[5] and Canada.[6] The latter, in particular, enacted the so called Canada Access to Medicine Regime (CAMR), which was considered as a model by the EU during the adoption of the Regulation n. 816/2006. These instruments have basically remained unexploited in all but one case.

Indeed, so far, only Canada has authorised this mechanism of compulsory licensing in order to allow a domestic enterprise to produce and export an anti-retroviral drug to Rwanda. This compulsory licence was authorised in order to face the dramatic HIV epidemic that was affecting the Rwandan population. The track started in 2006 with Apotex’s request to produce the relevant drugs and was concluded in 2008 with the delivery of the first shipment of medicines. In this case CAMR proved to be quite burdensome, in terms of time and authorisations, and although the debate on its reform was commenced, the Canadian Parliament has not proceeded further.

So, by taking this into account in the present context of the Ebola crisis, it is natural to wonder to what extent the current instruments on patent compulsory licensing are still adequate. The relevant procedures, indeed, are quite complicated and demand a large expenditure of time. That is one of the key aspects to consider for enabling a suitable instrument. The issues, hence, still remain open. Although other possible routes may be adopted, it is undeniable that the regulation of compulsory licensing for exports should be reconsidered, both at a domestic and at an international level, in order to set forth a long-awaited and adequate framework in order to tackle future challenges. Perhaps, in this case, ‘better be safe than sorry’ is the best strategy to address these issues.

[1] See http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/10/news_detail_002190.jsp&mid=WC0b01ac058004d5c1

[2] See http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm

[3] See http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm

[4] Patent Act (India) Section 92A

[5] Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems [2006] OJ L 157/1

[6] Patent Act (Canada) Section 21