In Greece, both innovators and the generics industry find fault with the country’s rebates and clawbacks system, a hold over cost-containment measure from the country’s period of extreme economic turmoil. In conversation with PharmaBoardroom, Michael Himonas, GM of the Hellenic Association of Pharmaceutical Companies (SFEE) and Faye Kosmopolou, GM of the Panhellenic Union of Pharmaceutical Industry (PEF) discuss the system from both sides of the pharma spectrum.
Under the current system, which was put in place as a provisional cost-containment measure given the country’s turbulent economic situation in recent years, pharmaceutical companies are required to offer mandatory rebates based on their total sales to the National Organisation for the Provision of Health Services (EOPYY) -a 9 percent discount on factory price + an additional 2-21 percent depending on the type of product and the volume of spending- and to cover the amount in excess of the budget for the EOPYY and hospitals.
The EOPYY fixes an annual budget for outpatient pharmaceutical spending, an amount which often does not cover its total expenditure, with the burden falling on pharma companies to fill in the gaps. According to industry stakeholders, the system has also created adverse incentives such as over-prescription from doctors, overconsumption by patients, and inefficient pharmacy distribution.
A Pain Point for Innovators
Michael Himonas of the Hellenic Association of Pharmaceutical Companies (SFEE), the industry association that groups 40 global innovative biopharma companies and 20 local companies, was quick to speak out against the system: “These ‘mandatory returns’ are a serious concern for the industry and the key topic in our discussions with government. The Greek clawback and rebate system is the highest in Europe by far, taking up over 47 percent of sales, and it hits all pharma companies – whether local or international, big or small – who must pay back a significant proportion of their revenues to the state. Unlike other European countries which have capped their clawback system (Portugal) or replaced it with a discount scheme (Romania), the Greek clawback mechanism is out of control and unsustainable.”
The Greek clawback and rebate system is the highest in Europe by far, taking up over 47 percent of sales.
Michael Himonas, SFEE
“The current government is business-friendly and has proposed several positive measures. However, public spending on pharma is still considered an expense rather than an investment in public health; an unfortunate residual effect of the crisis years. The State is focusing on introducing new clawback calculation methods that create anxiety and dilute predictability, but this increased pressure will hurt innovation, lead to fewer investments, and the delayed introduction of life-saving new drugs to the Greek market,” Himonas continues.
Addressing Inefficiencies
Beyond the cost burden for pharma companies, another point of contention is the overall inefficiency of the system. With this in mind, the SFEE has proposed a two-pronged approach to the government. “The first prong is to increase spending gradually from its very low levels to cover the needs of the population. The second prong is to manage spending and reduce wastage within the system. Greater efficiency can be created by utilising already-available digital tools, registries, protocols, and enforcing greater control overall by the authorities,” Himonas argues.
He goes on to speak about the role of generics: “Greater generic penetration – at the right price – will also be important within this second prong. There are 80,000 doctors in Greece – one of the highest numbers per capita in the world – who are competing for clientele and are often willing to prescribe the most expensive medicines available to keep the same patients or gain new ones. The same results could often be achieved with a cheaper generic equivalent, but there is no incentive for doctors to prescribe such medicines.”
The Generics’ Viewpoint
Faye Kosmopolou from the Panhellenic Union of Pharmaceutical Industry (PEF), an organization that represents Greece’s generics industry, outlines her view of the government’s current approach: “Over the past decade, the Greek government has tried to control pharmaceutical expenditure by setting annual closed budget ceilings. Since 2014, the outpatient pharmaceutical budget has practically been fixed at about EUR two billion, a reduction of 62 percent compared to 2009, when the pharmaceutical budget was EUR 5.2 billion. This was mainly achieved through extensive price cuts, compulsory rebates, and the country’s unique clawback system.”
After a decade of pharmaceutical policy reforms, it was finally realized that focusing on pricing alone to increase generic penetration is a rather poor choice.
Faye Kosmopolou, PEF
“After a decade of pharmaceutical policy reforms, it was finally realized that focusing on pricing alone to increase generic penetration is a rather poor choice. The absence of economic incentives for both the patient and the pharmaceutical supply chain, as well as insufficient administrative capacity to control the unjustified switching towards more expensive alternatives, explains the stagnant generic penetration levels,” she goes on to say.
A Threat to Access and an Obstacle to Investment
Both Himonas and Kosmoplou agree that the system is damaging to Greece’s pharma ecosystem, hindering both access to medicines and investment. “Greece performs well on the European Federation of Pharmaceutical Industries and Associations (EFPIA)’s WAIT Indicator and is generally quite good in terms of access to new medicines. However, the good momentum that has been established in the last two or three years will not continue unless the way that mandatory returns are calculated and how the negotiation committee uses those mandatory returns changes,” states Himonas.
“The clawback mechanism was enacted in 2012, under the first MoU between the Greek government and the EU, initially as a temporary measure. However, since then it has been reinstated three times and this cost containment policy has become a permanent measure that makes the landscape very difficult for all pharmaceutical companies operating in Greece. In 2012 the clawback amounted to EUR 78 million while just ten years later it has surpassed EUR 1.36 billion. The dramatic and consistent increase of the clawback has proven to be unsustainable, a hindrance to local investment capacities, and a significant drawback for foreign direct investment in Greece,” says Kosmoplou.
