Espicom view : Essential Inventions' letter to the Greek Minister of Health suggests that the country uses compulsory licences to alleviate pharmaceutical supply problems that have resulted from Greece's austerity measures imposed in the face of its economic crisis. Essential Inventions argues that compulsory licensing would open up access, but it seems unlikely that this approach will be given serious consideration by the Greek Government. However, perhaps the real aim of Essential Inventions' approach is to serve to highlight both the situation arising in Greece, and the fact that pharmaceutical company monopolies can exacerbate the problem.
Essential Inventions, a US-based non-governmental pressure group, has written to Greece's Minister of Health requesting a meeting to discuss a co-operative agreement and a non-voluntary authorisation to use patents on pharmaceutical drugs that the organisation has proposed. To date, the arguments surrounding the practice have centred on developing countries, most recently and notably India. Greece, of course, is not a developing country, but Essential Inventions' proposal does shine a light on the effect Greece's economic problems are having on the country's ability to provide Greek patients with access to the drugs that they need.
Greece's economic situation is well-documented, as has been the response of the EU. One side-effect has been a drop in pharmaceuticals entering the country. In February 2013, the Greek government made claims that some 50 pharmaceutical companies were exacerbating the situation, with the country's National Organisation for Medicines investigating 13 firms, leading to the names of eight being handed to the Health Ministry for prosecution. The exact extent of the problem has been a cause for dispute; pharmaceutical companies will not want to be seen as causing supply problems, and so have made a careful PR play. However, it appears that the austerity measures imposed by the Greek government have led to severe cuts in pharmaceutical spending and healthcare funding. Consequently, Greek hospitals have incurred growing debts to suppliers and pharmaceutical companies, leading to companies reducing or stopping supplies of products until the debts are repaid.
On 8th March 2013, ahead of the annual meeting of its General Assembly, the Hellenic Association of Pharmaceutical Companies (SFEE) claimed that as a result of what it termed failures on the Greek Government's part, the healthcare sector in the country had reached an impasse. The SFEE commented that the provision of pharmaceuticals was at breaking point and warned that many medicines, including several of vital importance, would soon become unavailable in Greece. The SFEE pulled no punches, blaming the situation on the Greek Health Ministry for continually failing to correct 'mistakes' in pharmaceutical pricing and to allocate reasonably and fairly funds available for the payment of arrears. The SFEE claimed that pharmaceutical companies represented the only sector that had yet to receive a single euro from the National Organisation for Healthcare Provision (EOPYY), Greece's state-owned health insurer, or public hospitals, for two years, although the relevant funds had already been disbursed. The SFEE claimed that arrears now totalled some EUR 2 billion, leaving many companies unable to import products. The organisation further claimed that since December 2010, Greece had experienced an unofficial 'embargo' on new pharmaceuticals, both branded and generic.
The SFEE represents 29 Greek companies and 38 multinational subsidiaries, with such companies including Abbott, GlaxoSmithKline, Novartis, Boehringer Ingelheim and others. It is unsurprising, therefore, that the organisation has been explicit in condemning the Greek government, whilst painting the response of its members in the best light. Nonetheless, it is undeniable that the situation concerning access to medicines across the board in Greece is extremely troubling, and indeed may well be at the point of crisis. The outcome of this could be that a member of the EU finds itself suffering the same pharmaceutical supply problems as is seen in least developed countries. Against that backdrop, Essential Inventions' letter to the Greek Minister of Health becomes clear.
Interestingly, Essential Inventions' proposal, whilst advocating the use of compulsory licensing, does not suggest that the licences could be issued in order to allow domestic Greek pharmaceutical companies to produce generic versions of patented drugs. Instead, the organisation envisages that once the compulsory licences have been granted, Essential Inventions would then enter into negotiations with its own suppliers in India, Canada and elsewhere to gain supplies from outside of Greece. It seems unlikely that the Greek government would consider this as an option; Greece is a member of the World Trade Organization and bound by the WTO's rules. Whilst the TRIPS agreement does give countries the option of issuing compulsory licences, in the case of a country such as Greece, the expectation would be that Greek firms produce the drugs in question. Of course, the TRIPS agreement is generally assumed to exist for the benefit of poorer nations, which would again lead to a question of whether Greece would want to travel down this road, or indeed if the rest of the WTO would allow it.
This is not the first time Essential Inventions has pushed for opening up markets for patent-protected innovative pharmaceuticals for generic competition. Indeed, Essential Inventions has argued many times in the past for compulsory licenses, and even for the US National Institutes of Health to use the Bayh-Dole Act to authorise third-party manufacturers to produce ritonavir, but its various proposals have gained little headway. However, that perhaps is not the point. The organisation makes these proposals as a way of highlighting the monopolies innovative pharmaceutical companies have. It seems unlikely that Greece will consider the organisation's proposal, even despite the worrying situation regarding pharmaceutical supplies. However, the fact that the proposal has been publicised and has led to debate in many circles, will count in Essential Inventions' favour.