A number of member states want the European Commission’s competences in health and pharma policy to be upgraded in order to face more effectively the rising challenges in the field, Greek Health Minister Andreas Ksanthos told EURACTIV.com in an interview.
Speaking on the sidelines of the “The Left’s vision for a sustainable pharmaceutical policy” event organised on 6 November by GUE-NGL, Ksanthos said that achieving a fair pharmaceutical policy was a “difficult equation”.
The issue, he said, has three parameters: encouraging innovation in order to produce effective medicines with added therapeutic value, guaranteeing universal and equal access for all EU citizens to new therapeutic regimes and thirdly, having sustainable health systems.
“We need an intervention covering all three parameters,” the leftist minister said, adding that an upgraded European policy on health and medicine was required.
“So far the approach has been a national competence as the European Commission has a rather marginal role. Our request is to reconsider the Commission’s competences and to promote coordination and exchange of information,” the minister said.
According to Ksanthos, EU countries with serious economic problems have a much more vital need to move on to a common European framework that guarantees these parameters.
However, he said, there is “great resistance” from some major countries, especially those with a strong domestic pharmaceutical industry.
“Guaranteed coverage is the crucial issue: we now have to reinforce this approach to the needs of patients without any exclusion. It is in full agreement with the WHO’s proposals, and at the same time constitutes the dividing line between progressive and conservative policies,” he explained.
Innovation and public intervention
Referring to the need to encourage innovation in pharma, he said it was necessary to upgrade public scrutiny on this matter. In a number of countries, he said, much of the funding seems to be related to public resources. Research institutes and universities produce innovation, which is then used by the pharmaceutical industry.
“That is where I think we need to find a model of enhanced public presence in the field of research and development,” he said.
He added that this would also make it easier for research to turn to medicinal products, which the industry currently does not invest in, either because the population target is limited or because there is a radical eradication of a disease so there is no commercial value in the long-term.
The European healthcare sector is divided over the “actual value” EU governments pay for the authorised and partly public-funded novel drugs, compared to medicines already on the market.
Another aspect Ksanthos raised was the collaboration among several EU member states aiming to enhance their cooperation and jointly negotiate with the pharmaceutical industry on drug pricing.
Up to date, two groups have been formed: Beneluxa, comprising Belgium, the Netherlands, Luxembourg, Austria, Denmark and Ireland, and Europe’s south “Valletta Declaration”, which groups Italy, Spain, Greece, Cyprus, Portugal, Malta, Romania, Slovenia and Croatia.
He said these countries want to adopt a common approach to assessing new medicines if they have added therapeutic value but also when it comes to drugs’ price negotiations.
“We believe that this is a one-way street and the Commission, the representatives of patients and political forces, NGOs, and especially the pharmaceutical industry must understand it.”
Ksanthos said today’s system was unsustainable, noting that the tendency to constantly produce new pharmaceutical products at exorbitant prices brings about instability even in rich countries.
“There is no way to allow access to modern medicines only to rich countries and people.”
As for the “Valletta Declaration”, he said the next objective is to find the proper legal framework for this collaboration.
Athens has already made a proposal for the legal framework as a basis for discussion and the participating states have sent their proposals. At the next meeting in Bucharest at the end of the month, the countries hope to move a step further.
“It is an unprecedented process for the European standards, but progress will change the landscape radically, especially the link between business interests and the needs of society.”
Six southern member states have signed a common declaration, aiming to enhance their cooperation and jointly negotiate with the pharmaceutical industry on drug pricing.
Clawbacks: The hot potato
Greece introduced a clawback provision in 2012 as a “temporary” mechanism aiming to reduce public spending on hospital healthcare.
The logic behind the move suggests that the consumption of prescription drugs is inconsistent with the real medical need. Consequently, the budget overrun must stem from overprescription of pharmaceutical preparations or other possible shortcomings of the healthcare system.
The clawback calculation is based on the market share as well as the development of each company. This means that if a pharmaceutical company’s sales grow in line with medical demand, then its bill to the state also increases.
The same measure is also applied in other EU countries but in the Greek case, it’s 3.5 times higher than the EU average, which has triggered the reaction of the pharma industry.
Asked how the Greek government is planning to address the issue, Ksanthos acknowledged the pharma industry discomfort and said: “We are paying today for the periods of utter indecency, lack of control mechanisms of extreme speculation and management viciousness”.
“This concerns a period of 15-20 years. We had an explosion of pharmaceutical spending in the country that cannot be justified by population and epidemiological data,” he said.
This is why, according to Ksanthos, the country’s lenders targeted the drug sector and pushed to have interventions of a horizontal nature and drastic cuts. “We are now trying to achieve a new balance.”
“Without ignoring the guaranteed non-discriminatory access line, we want to ensure that there is a demand control based on scientific criteria rather than arbitrary accounting criteria.”
He admitted that the pharma industry has borne its share of the burden during this period but reiterated that the most affected group were the citizens, who have a very high percentage of out-of-pocket payments to get their medication.
Ksanthos said collective efforts must be made by the industry, the society and the state itself, which should gradually start investing more resources.
“This year, we have the first boost to the closed budget for hospital drugs in 2019 by €45 million, a 10% increase,” he said.
“It is the first step we made in the new post-bailout period having larger fiscal space. The trend will be like that. Structural evaluation and prescription measures both reduce the overrun and reduce the burden of clawbacks and rebates,” he said.
Protect healthcare systems from scandals
The minister also talked about the ongoing debate in Athens about several scandals in the healthcare that have been revealed since Syriza took power.
The Greek government launched an official investigation into pharmaceutical giant Novartis, following the publication of allegations of corruption and bribery in national news media.
Ksanthos said it was too difficult to estimate the public money lost due to the scandals. “However, there are several protected witnesses in the Novartis case that talk about several tens of billions. This remains to be seen in the judicial investigation that is underway.”
“For the first time we have such a serious and in-depth investigation, and the truth is that while everyone knew a party was taking place in the health and medicine sector, the previous governments never had the political will to publicly open this debate and to deal with it in a serious and institutional way.”
“The political responsibilities are taken for granted. We want this investigation to bring results […] to assign possible criminal responsibilities either to state officials or to political personalities, it will be investigated and decided by the judiciary.”
“Both in the ministry of health and the ministry of development and commerce, which was deciding about drug pricing until 2010, there is a serious lack of transparency in how medicines were priced at that time.”
“But what we want most is to strengthen institutional interventions that shield the health system. People need to be convinced that after a few years we will not be discussing the same things,” he concluded.
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