Greece's health minister has proposed a four-year framework deal to representatives of innovative pharmaceutical associations under which they would pledge to boost clinical trial activity in the country, while requesting that producers help to reduce the cost of expensive cancer drugs.
IHS Life Sciences perspective | |
Significance | Greece's health minister has proposed to innovative pharmaceutical companies a four-year framework agreement that would involve producers investing around EUR1 billion (USD1.1 billion) in clinical trials in the country during the duration of the agreement. At the same time, he requested an agreement with producers over the cost of expensive cancer medicines to the Greek state. |
Implications | The minister stated that an agreement with producers on the cost to the Greek government of expensive cancer drugs was needed to prevent them having to resort to options such as compulsory licensing. |
Outlook | The new Greek government is obliged to find a way to cover the cost of providing healthcare to uninsured citizens, having been elected on a promise to do so. New regulations affecting the prices of expensive medicines will probably be proposed in the near future. It remains to be seen whether the Greek authorities are able to balance the potential negative impact to the pharmaceutical industry of further price cuts with a more positive regulatory framework to support the development of the pharmaceutical industry in the country. |
Greece's health minister Panagiotis Kouroumplis has proposed a four-year co-operation framework to representatives of the Hellenic Association of Pharmaceutical Companies (SFEE) in the presence of Richard Bergstrom, the head of the European Federation of Pharmaceutical Industries and Association, under which producers would commit to investing around EUR1 billion (USD1.1 billion) in clinical trials in the country over the term of the agreement, reports Greek newspaper Ta Nea. As the source reports, the proposed deal also concerns investment in the production and packaging of pharmaceuticals in Greece.
Minister requests deal on cancer drug prices to avoid threat of compulsory licensing
Of significance to the innovative pharmaceutical industry, Kouroumplis is reported by the source to have requested at the 27 February meeting that Greece be granted special status with regards to the prices of oncology drugs during the term of the agreement. He stated that this is to avoid the Greek authorities resorting to extraordinary measures available to them under the auspices of the World Trade Organization, including the compulsory licensing of drugs. According to the source, as a compensatory measure, the Greek Ministry of Health offered to exclude VAT, vaccines, and medicines reimbursed as part of the Pensioners' Social Solidarity Benefit within the state pharmaceutical budget.
EFPIA and SFEE heads show "understanding" on subject of cancer drugs
According to Ta Nea, Konstantinos Frouzis, the head of the SFEE, and Bergstrom spoke of the meeting's usefulness, while also recognising that they need to help with covering the cost of medicines for the country's uninsured. Furthermore, the source reports that they showed "understanding" on the issue of the prices of cancer medicines.
Minister attacks profligate pharmaceutical policy of last 10 years
Greek newspaper I Avgi reports that the health minister stated at the meeting that pharmaceutical spending in Greece had reached the level of a country of 40 million inhabitants during the last 10 years (Greece's population is around 11 million). He is reported as saying that the "big winners" during this period were pharmaceutical producers, particularly multinationals, since generics penetration continues to lag behind in Greece. He reportedly pointed to a large increase in annual spending on expensive medicines subject to special regulatory provisions (FYK), which has increased, according to the minister, from approximately EUR400 million to EUR850 million in the past five years, compared with an international average spending increase of approximately 5% annually. The source also quotes Kouroumplis as stating that Greece is facing a crisis, with around three million citizens without health insurance cover, emphasising in particular the plight of cancer patients who are forced to interrupt treatment because of the high cost of medicines. In summary, the minister is reported as saying that pharmaceutical policy will focus on new and expensive medicines, and not on cheap ones.
Outlook and implications
Kouroumplis has bemoaned the fact that so few clinical trials are conducted in Greece, while the value of the trials conducted in smaller countries, such as Portugal, is higher. The Greek MoH has stated that under the above-mentioned framework, it would update the institutional framework for conducting clinical trials, reports I Avgi. This may demonstrate a new commitment to improving the investment landscape for the pharmaceutical industry in Greece.
Recently, the Greek health minister has raised the possibility of a new change in price regulation, under which some drugs would have a dual price – an official one, which would be public, and a confidential one, which would be used for reimbursement purposes (see Greece: 16 February 2015: Greece's MoH announces changes in medicine price regulation). This could potentially represent a solution regarding high-cost oncology drugs, since, in the event of a probable further price reduction in Greece, producers would be keen on any price-reduction contagion being contained, which a system with confidential reimbursement prices could achieve. Similar mechanisms operate in other markets, such as Poland, where undisclosed discounts are not reflected in the official price of some expensive medicines.
Raising the possibility of Greece opting for compulsory licensing of drugs is certainly a raising of the stakes on the part of the new Greek government. However, given that it was elected partly because of its promises to deal with the crisis of millions of Greeks not covered by social health insurance, the administration will have to attempt to realise these pledges. Inevitably, this will involve the government seeking to ensure that pharmaceutical producers cover a proportion – potentially quite a significant one – of the expense.