Greek pharma boss: Patients are punished when innovation is penalised

Apostolides: "During the years of the crisis, Greece has dramatically cut pharmaceutical spending, which today stands at 50% of the European average." [European Commission]

Patients are “punished” due to a lack of innovation-driven structural reforms in a crisis-hit public health system, the head of the Greek pharma industry said in an interview with EURACTIV Greece.

Pascal Apostolides is the president of the Hellenic Association of Pharmaceutical Companies (SFEE).

He spoke with EURACTIV Greece’s Nikos Lampropoulos.

Despite the drastic reduction of pharmaceutical expenditure in Greece, an OECD survey identifies a number of remaining inefficiencies, IE in the use of antibiotics or hospital spending, which are still at very high levels compared with the European average. What is your view?

During the years of the crisis, Greece dramatically cut pharmaceutical spending, which today stands at 50% of the European average.

Moreover, with a closed-end budget in place – which, it is worth noting, has not been established on the basis of epidemiological or no sociological criteria – any scope for savings has long been exhausted. Rationalisation efforts should instead target other cost centres that together account for 85% of total expenditure.

Still, as far as pharmaceutical expenditure is concerned, further rationalisation is feasible, through the completion of structural reforms, including patient registries, therapeutic protocols and the Health Technological Assessment (HTA). We have consistently called on the government to urgently implement such reforms.

Have these reductions led to a deterioration in healthcare provision in Greece? Would you say that Greek patients are now at risk?

The link of expenditure to a rapidly shrinking GDP, the underfunding of the health system, the lack of primary healthcare along with under-resourced secondary care put a burden on public healthcare units in the face of increased demand and have hampered the access of vulnerable social groups. And this does not have to do with the economy alone; it is a matter of public health.

The higher incidence of mental disorders, addiction problems and substance abuse, suicide and mortality from ischemic heart disease are the most visible effects of the crisis on the health of the population (data from National School of Public Health), which are unevenly distributed among the residents of the country, with the lowest social strata facing the highest risk.

The available data and international literature show that the crisis has taken a heavy toll on society, causing a rise in the poverty rate, higher out-of-pocket pharmaceutical costs for patients, less recourse to dental care and other services that are considered luxuries, difficult access to a doctor or a primary care unit, a surge in depression, a large-scale outbreak of epidemics, including malaria, H1N1, West Nile virus but also Hepatitis C and HIV, higher infant mortality, etc.

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These devastating social consequences result from the reduction of public pharmaceutical expenditures, which has in effect been implemented by shifting the financial burden to patients and pharmaceutical companies, thereby driving Greeks to pharmaceutical poverty relative to other European citizens and causing the country’s health indicators to plummet.

That is, the state allocates fewer and fewer resources to pharmaceutical care, having cut pharmaceutical expenditure by more than 60% compared to pre-crisis levels, and at the same time increases patient co-payment and the clawback and rebate rates imposed on pharmaceutical companies.

On the other hand, Brussels officials argue that rare diseases and the lack of interest from pharmaceutical companies jeopardise the access of patients to medicines. What exactly is the situation in Greece?

There is a lack of reforms, of meaningful interventions in the right direction, aimed to deliver a rational and patient-centered health system. There is a chronic failure to implement those structural changes that are needed to ensure – in an inclusive manner – the right of Greek patients to use essential and often life-saving treatments and benefit from scientific advances and progress. Instead, once again we see across-the-board revenue-collecting measures that are detrimental to Greek patients and innovation. The government has recently revealed its intentions regarding the measures proposed by the ministry of health. In order for a new active substance to become eligible for reimbursement in our country, the following shall apply:

Instead, once again we see across-the-board revenue-collecting measures that are detrimental to Greek patients and innovation. The government has recently revealed its intentions regarding the measures proposed by the ministry of health. In order for a new active substance to become eligible for reimbursement in our country, the following shall apply:

  • A requirement that it must have been assessed by six (6) countries operating Health Technology Assessment (HTA) systems; and
  • an additional mandatory discount of 25% on the nominal price, which is already one of the three lowest among the EU 27 countries.

What do the above measures really mean? First of all, they mean additional long delays (at least 2-3 years) in the launch of new medicines on the Greek market, with the risk that some products may never make it.

HTA bodies have an advisory role and assess different things. The proposed six HTA-operating countries (UK, France, Italy, Portugal, Sweden and Spain) have each different HTA procedures, assessment criteria, and implementation modalities. It is extremely rare for a single formulation to satisfy the condition of having been approved in all six countries. In other words, we would potentially deprive our country of medicines that are necessary for us but are not assessed by the countries of the north, for example, thalassemia treatments.

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Furthermore, the government wants to impose an additional discount of 25%, in an environment already full of mandatory discounts (rebates) and refunds (clawbacks), which will certainly prevent many innovative medicines from coming to Greece.

However, by penalising innovation, it actually penalises Greek patients, turning them into second-class citizens with reduced rights. Indeed, if these across-the-board measures are to be implemented, it is certain that many companies will be discouraged to bring innovative products to Greece.

Do you think there is another path that could ensure a reduction of expenditures and at the same time preserve the quality of care in Greece?

Respecting the country’s limited fiscal capabilities and providing a high level of care to citizens are not incompatible goals. The achievement of both these goals, however, requires bold reforms to remedy the chronic weaknesses and failures of the public health system. This can be done by reallocating the available resources and putting them into rational use exclusively geared to the real needs of Greek patients.

To this end, of course, we don’t need to reinvent the wheel, but to use proven and effective options that are already applied in many European countries, and this has to be done immediately because any further delay would be harmful to Greek patients.

What are the reasons why, for so many years, the system was out of control, and no rationalisation effort was carried forward? Where would you put the blame?

We all know of Greece’s weak public administration and institutional gaps in many fields, which have resulted in the emergence of irrational practices and distortions, but also a lack of good practices to address these problems.

There is no doubt that the faults are many and varied. However, they have already been pointed out in detail and are well-known. What we need today is not endless fault-finding but rather the urgent implementation of policies to correct these faults.

The Greek pharmaceutical industry has tangibly demonstrated its support to the government and has also submitted a comprehensive set of proposals to this end, acting as the government’s strongest ally in the effort to deliver a viable, functional and effective public health system in line with European standards.

How is the industry (domestic and multinational companies) coping with the dramatic reduction in pharmaceutical expenditures and the successive measures (clawbacks, rebates, spending caps, etc.)?

Public pharmaceutical expenditure, after successive reductions in recent years, is now subject to a cap of €1,945 million and €570 million for hospitals; this amount is insufficient and leads to continuous and uncontrollable overruns. This is so because it has been determined arbitrarily, without taking into account the real needs of Greek patients, the burden of tertiary care and the soaring numbers of uninsured citizens.

The additional needs are covered, on the one hand, by patients (from 9% in 2009, average out-of-pocket spending rose to 26% in 2015) and, on the other, by the industry, which through mandatory discounts and rebates finances 25% of pharmaceutical expenditure. That is, one in four medicines is given by the industry for free.

On top of this, the government now introduces another measure to permanently squeeze money from pharmaceutical companies. In an already suffocating business environment of unreasonable clawbacks and rebate rates, it acts to impose an even heavier burden on the industry. Indicative of the situation facing the industry is that clawback payments from pharmaceutical companies to EOPYY in the first half of 2016 grew by 42.3% relative to 2015. Moreover, the newly-introduced hospital clawback amounted to €140 million (41% of expenditure) and is set to end the year at twice that level.

Considering that the budget allocation is just €570 million, this creates an unsustainable burden. Meanwhile, the government, instead of finally proceeding with structural reforms, is promoting new measures that deal a heavy blow to innovation, threatening the viability of the pharmaceutical industry which has long operated beyond the limits of its strength, with the risk of many pharmaceutical companies being put out of business, threatening thousands of jobs and creating conditions of disinvestment in the sector.

When you talk to the European Commission, what do they tell you? Do they lend a listening ear to your concerns? Do you see some discrepancy in the European Commission’s stance through DG Health, and as a member of the Troika? How cooperative or effective is the Greek government?

It is important to note that our communication with the European Commission is very good. They seem willing to listen to our concerns and needs, and they are also responsive and cooperative in search of ways out. Indeed, in the recent multiparty institutional debate at the European Parliament on 25 January, there was a discussion of the issues facing the healthcare sector, and the need was recognised to develop a national health and pharmaceutical strategy, but also to ensure the sustainability of the public health system, always prioritising patients and ensuring their access to the necessary treatments for their lives.

At the same time, there was agreement on the need to enhance access to innovative medicines following an outcomes-based assessment, through Health Technology Assessment (HTA) systems, as is the case in most European countries. The wider use of therapeutic protocols and patient registries can effectively help to control demand and expenditure and ensure that the patient has access to the right treatment at the right time. In short, all have acknowledged that HTA assessment is an important tool for health policy, as it can demonstrate the value for money and the added value of innovative medicines, thereby improving patients’ quality of life and also contributing to the rationalisation of the Greek health system.

In short, all have acknowledged that HTA assessment is an important tool for health policy, as it can demonstrate the value for money and the added value of innovative medicines, thereby improving patients’ quality of life and also contributing to the rationalisation of the Greek health system.

Certainly, Greece’s partners should on their part provide concrete proof of their understanding. The impetus for the implementation of the necessary reforms should be accompanied by setting pharmaceutical expenditure at a level that allows to covering the actual needs of Greek citizens, as health is an inalienable right of all European citizens. This is a hard-won right and should not be lost.

What is your stance on the effort of the Maltese Presidency – following the relevant European Council resolution – to form regional “alliances” for joint negotiations with pharmaceutical companies on pricing issues? Do you think that the final negotiated price should be made public?

It is reasonable and legitimate to seek the adoption of best practices in order to promote the objective of rationalisation and sustainability of the public health system. We actively participate in this dialogue, contributing our ideas and suggestions. Addressing the distortions requires general as well as specific interventions.

For Greece, it is absolutely necessary to prioritise the institutional changes and tools which are already applied in Europe and which can quickly bring about drastic results. We are in favour of joint actions, provided that they take into account country-specific needs and circumstances – fiscal, demographic, epidemiological – which often vary widely across countries.

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