Can Greek Healthcare Policy Go
from Noise to Signal?
By Alexandra Loli, Publisher | Business Partners, May-Jun 2019

The world today requires the very best that every industry has to offer, and we are constantly striving to come up with ways we can innovate and lead.
In the pharma industry, we work every day to ensure the next generation is healthier than the last. Our work pushes for healthier societies and serves as a reminder that our job is not yet done.
We must continue to raise the bar for ourselves and for the healthcare industry at large so we can continue to earn our place in people’s hearts and minds everywhere. We will deliver on our aspiration by developing innovative medicines including shorter, safer and more effective treatment regimens. Our vision of the future is that a combination of digital technology, pharmaceuticals, devices, behavioral science, and timely clinical interceptions could stop chronic diseases such as cancer in their tracks and fix inherited conditions before they become serious. This idea of a “world without disease” sounds like science fiction, but it can be achieved if all stakeholders work together— with healthcare services, governments, payers, academia, patient organizations and private companies combining their strengths to create a healthier future. One obvious area is the need for better electronic health records. With blockchain technology and its ability to store data in a series of nodes across a network, there is the potential to create a system where a single health record could be used throughout a patient’s life. In many countries, including the United States, this would overcome the problems created by a fragmented health system where different clinics, hospitals, and healthcare providers find it difficult to share patients’ medical information. Patients could own that data and share it as needed. They will have to start taking more responsibility for their own health if the goal is to be achieved.
In the industry, we have the capabilities and we have the responsibility to free the world from disease. At many corporates, jointly with external partners and our global innovation network, we have started paving the way to a world without disease. We just need to reframe healthcare to be viewed as an investment rather than an expense, similar to housing. We can collaborate to intelligently design and disrupt every stage of the healthcare experience to provide better value to patients.
And that’s a commitment we share, the commitment of putting people first. The commitment to deliver life-changing, life-enhancing, and life-saving solutions to more people, in more countries, in every circumstance.
We’ll build on the values we cherish—tolerance and diversity, love and compassion, courage and resilience—
in order to deliver on our renewed purpose: to change the trajectory of health for humanity.

Imagine a reality in which diagnosis and treatment precede illness, in which interventions are non-invasive, painless and bloodless, and in which recovery is faster and return to normal life is immediate. This is the new reality.
Technology is driving medicine and surgery to innovative solutions that we could never have imagined.
Robotic surgery, 3-D printing, artificial intelligence, and the use of big data for personalized healing solutions
are just around the corner. The ability to interconnect hospitals, doctors, ambulances, patients and medical devices to provide care in immediate time and space is much closer than we can imagine.
If there is one single thing that could make the system work better, that is collaboration to accelerate the use of data and analytics and transform it into knowledge that can guide and improve decision making. This would assist in allocating resources based on population and disease needs, improve patient clinical outcomes, and help us to better understand where to invest and how.
The problem with data is that there is too much of it— and there is always more coming. Nevertheless, we shouldn’t understate the importance of collecting the right kinds of data and using them effectively. We have to focus on data that, if managed correctly, can shift the needle in the direction that always serves the benefit of the patient and the healthcare system.
Hospital published results, clinical evidence, real world evidence, registries, therapeutic protocols, procurement and reimbursement data, arrays, patient waiting lists and supply chain data are just some examples of current challenges that still have to be adapted in the Greek healthcare environment, especially in the context of the new digital era. With artificial intelligence, e-commerce, e-health, e-medical records, operating room optimization, robotics and advanced diagnostics on their way, it is important to prepare for the future and for the opportunity to combine data for optimal patient results through advanced integrated healthcare systems. Digital transformation will change all that we know, and we need to be prepared.
The member companies of AmCham’s Medical Devices and Diagnostics Committee, based on their international experience, have for years been engaging in dialogue with an array of government officials on key issues relating to our healthcare system, proposing solutions and ways to implement these. We believe that with strong collaboration among all stakeholders, we can change the trajectory of health for humanity.
As increasing life expectancy and chronic diseases due to modern lifestyles are leading to budget shortages in healthcare systems around the world, the solution is innovation. A smart healthcare system that will evaluate efficiencies and outcomes through good use of data and digital technologies. We believe in such a system and its implementation in Greece.
Can we hope for a brighter tomorrow in medical devices through digital transformation?
Absolutely. Together with internal and external partners, we can advance the future of healthcare with a collective vision of curing patients, always keeping in mind that any disease is treatable, curable or preventable.

Pharmaceutical innovation continues to face many challenges in Greece, with hospital medicines used to treat severe or life-threatening diseases such as cancer impacted the most. Cancer is the second leading cause of mortality in Greece, accounting for a quarter of all deaths, while mortality rates for men from lung cancer in Greece are among the highest in the EU (62 per 100 000, with an EU average of 54).
The introduction of closed budgets for hospital pharmaceutical expenditure aimed at reining in the state budget but failed to meet real patient needs or support the added value of innovation. Delays in the implementation of healthcare reforms resulted in clawbacks, which have risen significantly since 2016, being extended until 2022. In fact, last year, the contribution of the pharma industry amounted to approximately 50% in the hospital  hannel. The pharma industry thus operates in an unpredictable environment that challenges its viability. Unfortunately, spending on pharmaceuticals will remain a relatively easy target for rationalizing healthcare costs. With governments likely to continue to apply pressure on pharma spending, patient access to new treatments may be impacted.
There is no one size fits all solution for the pharma budget; change cannot be driven by horizontal measures
but by more holistic healthcare reforms. Hastening the implementation of HTA assessments and
therapeutic protocols, reviewing the role of generics and biosimilars, deducting clinical trial investments from clawback, and increasing the spending cap at a more realistic level could optimize the pharma budget
in the right direction.
There is an overarching goal for all stakeholders around healthcare to ensure patient access, and that should be everyone’s vision in the decisionmaking process.

Pharmaceutical expenditure has had its share of noise in Greece over the past decade. From cuts to increasing patient co-payments and shifting expenditure to the pharma industry through clawbacks and rebates, we have deflated our investment and maintained it below the €2 billion threshold mandated by our creditors. Yet this shift of burden (and responsibility) has run its course. It can no longer accommodate the innovation that allows us to go beyond what we thought was possible in terms of treatment outcomes.
We need to signal a change. The market is made up of two large segments: an innovator segment (products
protected by patents and priced to reflect their innovation) and an unprotected segment (off-patent and generic products offered at competitive prices). Across the world, increasing the share of the unprotected market creates the necessary fiscal space to accommodate investment in innovation, in a framework of monitored care provision facilitated by technology (e.g. prescription monitoring systems, therapeutic protocols). In Greece, we go our own way: We punish innovation through draconian entry barriers and hold a protective (price) shield over the unprotected market, which, as reported by IQVIA1, is the second most expensive market in the EU. How does this improve health and save lives? Why do we invest in pharmaceutical care if not for longer and better lives?
We expect to see inconceivable pharmaceutical innovation over the next years. Making the quarterly numbers
should not be the ultimate goal. What really matters is to create a vision for Greek patients. It is time for transparency in pharmaceutical expenditure and for matching expenditure to outcome, as per common sense.

As Greece is trying to recover from a deep economic crisis, the need for a pharmaceutical policy that takes into consideration the social as well as the economic aspect of pharmaceutical expenditure is today more urgent than ever.
According to a recent study by the Foundation for Economic and Industrial Research (IOBE), every one euro increase in the pharmaceutical industry’s gross revenue results in an increase of the country’s GDP by 3.9 euros. Additionally, for every person employed in the pharmaceutical industry, a corresponding 5.7 fulltime
equivalent jobs are created at a national level.
However, over the past 10 years, public pharma expenditure in Greece has decreased by 60%, mainly through the implementation of horizontal cost-cutting measures based on a solely budget-centric approach. The burden of mandatory rebates and clawbacks now challenges the viability of pharmaceutical companies, compromises patients’ access to innovative treatments and discourages investment in clinical studies.
Therefore it is necessary to introduce a new pharmaceutical policy that will serve the needs of patients, the economy and the industry by treating pharma expenditure as an investment and a tool for sustainable and inclusive growth. The focus must shift from restrictive measures to structural reforms such as the development of a new pricing and reimbursement system that recognizes the added value of innovation, the development of risk-sharing agreements, and the deployment of therapeutic protocols and patient registries to control the volume of prescribed medicines. At Roche Hellas, we remain willing to contribute to this effort and support the reforms that can bring about an equitable and sustainable healthcare system in Greece.

New, innovative and extremely effective therapies are already changing patients’ lives around the globe. HCV eradication, the successful fight against many cancer malignancies, and the conversion of HIV and diabetes into chronic diseases are some of the greatest pharma innovation achievements of our times. However, breakthrough therapies always come at a cost, while national budgets are dealing with significant pressures.
In Greece, we faced the first wave of this challenge defensively. Instead of structural reforms towards market rationalization, the competent authorities focused their efforts in the implementation of horizontal fiscal measures that ultimately failed to reduce the total amount of pharma expenditure and actually shifted the relevant costs from national accounts to patients via increased out of pocket payments and to the pharma industry via uncontrolled paybacks.
What we missed all these years is the value of collaboration, the value of standing in each other’s shoes to address the challenges in a sustainable way. The era of the fourth industrial revolution has already begun with personalized medicines, gene therapies, cell therapies and medical precision in the forefront. Are we ready? Definitely no, if we choose to address the new challenges using yesterday’s tools. But certainly yes if we adopt international best practices to help us quantify future financial needs—such as Horizon Scanning—and to measure the outcome of our efforts in order to transform paybacks from a punishment tool into a rewarding one. The introduction of the reciprocity principle in every evidence-based policy from now on could prove to be a game changer by motivating all stakeholders to bring the best possible outcome in favor of patients, taxpayers and growth.

Ever-increasing financial constraints urge governments and healthcare organizations to rationalize public expenditure. Centralized procurement of medical technology has been considered as an instrument to control and reduce public spending. Despite this, a predominantly price-focused procurement process may become a source of many problems. Centralized procurement strategies may increase buyer power and achieve lower purchasing prices, driven by economies of scale and lower transaction costs. However, as they solely pursue immediate savings at the sourcing stage, such processes may fail to create long-term value. Creating value through procurement shall focus on the broad outcome-based objectives of high-quality care. Additionally, the aggregation of demand through centralized tenders is vulnerable to the heterogeneity of the stakeholders’ needs and the frequently short-term and opportunistic political agendas. When not carefully designed, centralized tendering may limit patient access to innovative technologies or specialized resources, capabilities and knowledge. Finally, the central public buyer is endowed with a market power that necessitates expertise,
maturity and transparency. All-or-nothing purchasing may alter the market structure dramatically, reduce competition and result in higher procurement costs in the future.
Centralized public tendering of major medical technology has recently been experienced in Greece. When evaluation of total cost of care and active strengthening of competition were considered, low prices and long-term commitments of quality were achieved. On the other hand, when the competition was restricted in any way, minimal to zero savings were yielded. The public sector can learn from these experiences and realize that procurement decisions send important messages to the industry regarding where to invest or innovate for greatest public value at a reasonable cost.

Our ship is far from land in relatively calm waters. We can feel the wind getting stronger. We can hear the thunder getting louder. We can see the lightning getting closer. We have seen the storm approaching for years. This March we felt raindrops. We have been talking about it, telling everyone who cares to listen. Not enough has been done. The Greek pharmaceutical budget is inadequate. There must be change. The budget must increase in order to be realistic for the population of Greece. Otherwise, patients in Greece will for one reason or another not have access to their therapies.
The system designed to provide patients in Greece with access to innovative, complex, hi-tech, temperature sensitive, lifesaving medicines from around the world cannot be sustained with such enormous, after-the-fact, retroactive, mandatory discounts. The first calculation of the rebates and clawback for specialty medicines in 2018 was a whopping 70%. A last minute, retroactive, budget injection temporarily saved the day—but the storm has hit.
Now we are almost halfway through 2019, and the clawback has grown. Parts of the pharmaceutical market will exceed 80% this year. Pharmaceutical companies have decided to hope. To hope and maintain supply until the last possible moment, because anything else is unthinkable. But the budget must increase. In the end, there is only one solution. The clawback must go and the healthcare system must get better at purchasing. I hope we reach safe harbor before the storm drowns us.

Sector sustainability, expenditure rationalization and R&D investments are the three pillars that will define the future of Greece’s pharmaceutical industry.
Sector sustainability: Public pharmaceutical expenditure has been reduced by over 60% since 2009 at the expense of patients and the pharmaceutical sector, which has contributed over 43% of the annual expenditure through clawbacks and rebates, pointing to a definite gap between the available budget and actual patient needs in the country. Additional funds must be allocated according to the needs of the Greek population, increasing the budget to realistic levels and allowing time to see the implementation of not yet materialized reforms.
Streamlined expenditure: Lifting all protection measures that exist today in the pricing system would allow faster penetration of usage of generics and biosimilars, ensuring the necessary savings needed to make room for innovation and contributing to a viable healthcare system. The abolition of the 25% additional rebate on new pharmaceutical products and a gradual decrease of rebates from 5% to 1% for 5 years would be an important step toward making innovative products and treatments available to Greek patients while also allowing the state to reap the financial benefits.
R&D enhancement: The pharmaceutical sector can contribute significantly to Greece’s economy and competitiveness by increasing investments in clinical trials in Greece. Subtracting from clawback the investments on clinical trials could result in investments rising to €200 million within in a couple of years, possibly as high as €1 billion over the next decade as enjoyed by Belgium today.

It is widely accepted that there is a significant discrepancy between the public pharmaceutical budget and Greek patients’ actual needs for pharmaceuticals. This is evident from the annual steady increase of the amounts for rebates and clawback (estimated at €1.4 billion total in 2018) and patient copays (estimated at €625 million in 2018).
The insufficient budget coupled with the delays in the implementation of structural reforms are not conducive to a sustainable healthcare system that serves patients’ needs. The delays in the introduction of innovative treatments are a perfect illustration of this. The average time between marketing authorization and patient access in Greece was estimated at 428 days by the EFPIA Patient W.A.I.T. Indicator Study 2018, compared to 100-200 days in northern and western Europe. The much-anticipated introduction of HTA has until now failed to improve the situation; the persistence of fiscal measures such as the 25% entry fee rebate does not help either. It is now one year since the last issuance of a positive list with new products and there are products that are not reimbursed in Greece despite having received EMA approval more than two years ago—that is 730 days.
At AstraZeneca, we have committed ourselves to pushing the boundaries of science to deliver life-changing medicines. At the same time, we want to play an active role in ensuring a sustainable healthcare system that will focus on patients and will enable pharmaceutical companies to contribute to the country’s return to growth. The increase in public pharmaceutical expenditure is a sine qua non of sustainability. In parallel, structural
reforms—such as HTA, therapeutic protocols, patient registries, primary healthcare—should be accelerated.

2019 is a milestone year for Greece, as the country puts the hard period of bailout programs behind it and moves forward toward a new era for Greek society and economy. Healthcare has been one of the most affected sectors during this period, with a drastic reduction of public funding, continuous cost-containment measures, and increased inequalities. Especially in the pharmaceutical sector, the fact that the system has not collapsed is due to temporary measures requiring increased paybacks from pharma companies. These measures have reached their limit and no longer serve their purpose.
So what are the real signals of a post-MoU era in pharma policy area?
• Patient centricity: A healthcare system must address the healthcare needs and preferences of patients.
This includes enhanced patient engagement in decisionmaking for both health policy (e.g. enhanced role in the HTA process) and direct care (e.g. enhanced role in treatment plans).
• Establishment of pharma innovation as a pillar for growth and sustainability: Implementation of a comprehensive pharmaceutical policy framework that recognizes the value of innovative medicines for the healthcare system and patients and incentivizes increased investments from pharma companies.
• Increased predictability: A pact with pharma industry with a consensus on the required structural reforms is also a clear signal of a sustainable and healthy healthcare and business environment, which can ensure long term patient access and medicine affordability.
• Focus on prevention: Design and implementation of long-term strategies and national plans based on Greek patients’ profile and epidemiological data, prioritizing areas such as vaccination coverage, smoking cessation, and reduction of CV/stroke risk and adopting KPIs for family doctors in primary care to promote these public health targets.

In recent years, we are witnessing another kind of technological revolution in the healthcare sector that is contrary to what we have been used to so far. The aging population with growing healthcare needs, the advanced capabilities of informatics in analyzing big data, the active role of patients in the decisionmaking regarding their treatment, and the limitations of healthcare systems to fund biotech innovation are among the key factors that are driving the industry to develop customized solutions for both healthcare professionals and patients, focusing on smaller target groups of end users.
In the field of ophthalmology, new technologies in the industry’s pipeline—available to healthcare providers— can provide even more solutions for better patient outcomes; accommodative intraocular lenses, digital visualization of operations, and correction of astigmatism and presbyopia are some of the milestones that we have already achieved. However, can the existing healthcare system reimburse horizontally the access to these services for an entire population that is getting older? Probably not. This is why customization, as an approach and flexible reimbursement policy, will make these innovative solutions accessible to whoever needs them the most and create a better balance between the industry, to continue producing innovation, and the healthcare providers and their patients, to benefit from these research outcomes.
In that context, all stakeholders should contribute to establishing this cost-benefit balance. If we want to ensure patients’ access to innovation aiming to a better quality of life, customization seems to be a necessity.

In response to the rising healthcare costs worldwide, governments are struggling to address affordability and optimal resource allocation through a combination of pricing and volume-control measures. Contrariwise, the Greek public pharma expenditure has been more than halved since 2009, due to the implementation of solely pricing-centric measures such as continuously increasing rebates, clawback and price reductions, while the coverage of uninsured population restricts further the already insufficient pharma funding. Despite these measures and the considerable risk they entail for the sustainability of the pharma industry, the industry remains resilient covering one fourth and one third of outpatient and inpatient spending respectively, while the rising forecast for 2019 demonstrates that structural changes cannot be further delayed.
Looking forward, we, as GSK, strongly believe that the time has come for norms to be challenged. The state should immediately enforce efficient mechanisms to ensure strict implementation of volume-control measures within a clear timeframe and with tangible results, hence abandoning the exclusive implementation of horizontal measures. Consequently, a predictable and stable operating model will be introduced with the potential to sustain industry investments and patient access to innovative treatments that has been significantly harmed almost a year now.
Finally, policies focusing on prevention, mainly through vaccination, should be prioritized as a means to protect public health and generate substantial savings by tackling devastating diseases that when left unprevented create significant burden to healthcare systems. In this light, the state should exploit the opportunity to exclude vaccines from pharma budget, if not redefining it as a whole based on actual population needs.

For more than a century, MSD has been inventing medicines and vaccines for many of the world’s most challenging diseases. As a company, we have invested 88% of our products in the fight of the 20 most important medical needs worldwide. MSD plays an important role in protecting children and adolescents from vaccine-preventable diseases. MSD is also inventing new ways to treat cancer with more than 900 clinical trials underway and a goal to transform the paradigm of cancer care.
As MSD Greece, we aspire to provide Greek patients with access to the upcoming wave of innovative medicines that will change the course of healthcare and will provide treatment and cure to many serious diseases. It is important for Greece to be able to absorb pharmaceutical innovation in an economical and sustainable way. We understand that policymakers are trying to find a balance between promoting and rewarding innovation, ensuring access to medicines, and sustaining the viability of healthcare systems. An open dialogue between the government and the pharma sector would improve the alignment of industry R&D and societal priorities and contribute towards the structural reform of the health system. A strategic plan could include, among other things, policies on improving the prescribing of therapeutic protocols, improving HTA and introducing e-patient records in outpatient and hospital settings.
We need to all work together to ensure that in the future the system delivers the right innovations to the
right patients at the right cost.