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There is no sugar-coating the healthcare environment in Romania. Over the past 30 years, Romania has had 36 ministers of health – the last having resigned in the heat of the coronavirus crisis just 12 days after his investiture – a damning indicator of the shambles in which Romania finds its healthcare system in after decades of chronic underinvestment and policy instability. For the last two decades, the Romanian government has consistently ranked at the bottom of European Union (EU) countries in terms of healthcare expenditure per capita.
This was perhaps understandable in the immediate aftermath of the 2008-2009 global economic crisis when the country was forced to pare government budgets to the bones. However, even as Romania has resurged to growth in the past few years, boasting some of the highest GDP growth rates in the EU – the European Commission estimates Romanian GDP growth in 2020 to be 3.6 percent – the stagnation in healthcare investment has continued even as the country contends with one of the world’s worst cases of brain drain. The United Nations recorded an international migration rate of 7.3 percent for Romania between 2000 and 2015, placing the country second globally, after Syria. In 2019, the resident population of Romanian was 19.4 million – the lowest level since 1967.
Exacerbating this issue is the rapid aging of the resident population. Currently, only 18.5 percent of Romanians are aged 65 years and over, but official statistics show that the aging process is accelerating. According to Eurostat numbers, the old-age dependency ratio – the percentage of retirees compared to the workforce – has increased from 21.5 in 2007 to 26.7 in 2017. While this anticipates significant rising healthcare needs in the country, it is unclear if the system would be able to bear the increasing strain.
As the Romanian proverb goes, ‘he that would eat the kernel must crack the nut’ (cine vrea miezul, să spargă nuca). The story of Romania in 2020 is the story of the intrepid and enterprising people that manage to – in spite of all challenges – triumph over daunting odds and deliver innovative therapies to healthcare providers and patients.
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The unfortunate truth is that it is difficult to imagine a frostier landscape for pharmaceutical companies than Romania. Dan Zaharescu, executive director of the Romanian Association of International Medicines Manufacturers (ARPIM) laments, “since the financial crisis in 2009-10, the Romanian authorities have built a hostile environment for pharma companies.” For the past decade, drug prices in Romania have been tied to a basket of 12 countries with the lowest drug prices in Europe, ensuring that Romania has the lowest drug prices in the EU. In addition, any generic compound is priced at a maximum of 65 percent of the originator price, and within a year, the innovator company has to match that price or withdraw their drug from the market.
However, the biggest bugbear for industry players – innovator and generic alike – is the exceptional ‘clawback tax’ that has been enforced since 2009, when the escalating financial crisis forced the Romanian government to introduce an emergency ordinance to supplement its medicines budget. Executive director of the Romanian Association of Generic Producers (APMGR) Valentina Băicuianu contextualizes, “in 2009, the clawback tax was agreed upon by the industry as a temporary measure to overcome the passing financial difficulties of the country.” Unfortunately, what started as necessity has since mutated into a crutch for the government to prop up the chronically underfunded public healthcare system, and as Băicuianu underscores, “despite economic growth, has not been decreased or removed.”
On this thorny issue both associations are in agreement. Zaharescu vents, “all spending above the [medicine] budget is paid by the industry proportionate to the market share [of each] marketing authorization holder. When introduced, the clawback tax was [effectively] 12 percent but it [has since been estimated] to have increased to 28 percent in Q4 2019.” This reflects the troubling reality that the medicines budget has not increased from 2012 to 2018, despite more drugs having been approved and reimbursed. He avers, “the pricing methodology is the root cause of medicine shortages. Certain medicines are no longer economically viable, and therefore are taken off the market despite a considerable number not having available alternatives.” Băicuianu concurs, warning that “more than 2,500 medicines have been withdrawn from the market [and] recently, the National Agency for Medicine and Medical Devices of Romania (NAMMDR) announced an additional 700 drugs to be withdrawn.”
With the current medicines budget deficit placed at a staggering RON 2.2 billion (USD 0.5 billion), the clawback tax does not seem to be going away anytime soon. To advance, both associations have joined forces to advocate for a gradually decreasing cap to be placed on the clawback tax. With the increase of the healthcare budget by 17 percent in 2019, there seems to be a glimmer of hope that a compromise could be reached.
However, Dr László Attila, president of the Committee of Public Health in the Romanian Senate, cautions that the problem is not simply with the level of spending but also the efficiency of existing spending. He points out, “in the past ten years, the healthcare budget has increased by 700 percent [but] the population might not have felt an improvement in the system for various reasons. Large investments had to be made in order to fix errors that arose from not taking the necessary steps at the right time,” suggesting that much of the investment was reactionary and ad hoc rather than strategic and planned.
Part of this inefficiency stems from the ailing public healthcare infrastructure in the country. He reveals a number of worrying statistics: “Romania has 450 hospitals built between the 1950s and 1970s which need to be replaced or be improved. More than 250,000 doctors have left in the last 15 years. With the average age of a Romanian doctor being 58 years, Romania has both the lowest and oldest numbers of practicing physicians, as well as one of the lowest numbers of specialists able to perform complex surgeries [in Europe].”
To exacerbate matters, with only 12,000 registered family doctors in the country, primary care is another weakness of the Romanian system. However, steps are being taken to remediate the situation. Dr Attila highlights, “in 2018, we increased the salaries of doctors and assistants by 172 percent and 72 percent respectively” in an attempt to stanch the flow of medical professionals leaving Romania.
Attila Fejer, general manager of Eli Lilly aptly terms the situation “a deadly cocktail,” summarizing pithily, “the government has a ‘firefighting’ or crisis management approach to the healthcare sector that is not sustainable. Every fourth patient’s cost is supported by the pharmaceutical industry, which is unfair.” Nevertheless, he admits, “there is a lot of concern and openness by the authorities to encourage innovations. One cannot blame [the current government for] not fixing in a couple of years what [developed over] the last 25 years.”
His colleague, Janssen Managing Director Sévan Kaloustian, chooses to strike an upbeat note after four months in his position. “My first impressions have been very positive. The economic dynamics of the country show a continuous and impressive progress over the past 15 years and there is ongoing open conversation between the private and public sectors, which offers fantastic prospects for the company. In the short-term, I would like to make sure that we continue the positive trend. Janssen Romania is treating more patients than ever before, which is our number one priority. At the industry level, we are 100 percent committed and focused on improving the ecosystem both independently and through ARPIM.”
Successful National Programs
Through the dedicated efforts of healthcare stakeholders, some bright spots can be glimpsed in Romania’s gloomy healthcare landscape.
The Romanian Mobile Emergency Service for Resuscitation and Extrication (SMURD) established in 1990, must surely be seen as one of the greatest achievements of the country’s healthcare system, testament to the feats that can be accomplished through sheer will and perseverance. Founded by Dr Raed Arafat, secretary of state at the Ministry of Internal Affairs, himself an intensive care physician, over the past three decades, Dr Arafat has worked tirelessly to expand the services offered by this critical program.
Today, SMURD coordinates all of Romania’s emergency response efforts in collaboration with the Ministry of Health, engaging not only in medical but also non-medical response, including road rescue and mountain rescue. By 2023, nearly EUR 1 billion would have been invested in this program through a mix of national and EU funds, all of which have been funnelled into enhanced capabilities in land rescue, air rescue and intervention, search and rescue, sea and water search and rescue, as well as medical interventions.
SMURD divides emergencies into three different coloured codes: green, yellow and red. Red is life-threatening and require quick interventions. Impressively, in the event of a code red, SMURD can be on site between seven to nine minutes anywhere in Romania.
Cecilia Radu, general manager of Novo Nordisk, shares how she advocated successfully for the launch of the National Diabetes Prevention program in 2020. She explains, “an estimate 11 percent of Romanians live with diabetes, or around 1.75 million patients … We estimate that only seven percent of the diagnosed patients with diabetes are achieving their therapeutic goals.” In addition, the lack of specialists in Romania is a challenge; Radu cites, “there are only 1,000 diabetologists for nearly 900,000 patients [and] a third of them reside in Bucharest.”
The costs are high. She reveals, “In 2017, Novo Nordisk conducted a health economics study regarding the cost of the cardiovascular complications of diabetes. Annually, the government spends approx. EUR 270 million (USD 301.6 million) to treat diabetes patients in Romania.” As a result, within ARPIM, Novo Nordisk spearheaded a diabetes working group together with eight other companies with a diabetes portfolio, signing on World Diabetes Day in 2018 a memorandum of collaboration with the Diabetes Association. Radu adds, “in April 2019, Romania was the first country in Europe to launch a Diabetes Forum [and after] a full year of consultation, debates, and stakeholder engagement, on 24 February 2020, a draft law regulating the national diabetes prevention program was introduced on the Parliament’s agenda, which is great news for Romanian patients suffering from the disease or having a risk of developing diabetes in the future.”
In spite of the external environment, the Romanian national culture seems imbued with a tradition of resilience and strength in the face of adversity. In order to run successful affiliates, general managers have to choose to identify opportunities rather than bemoan challenges.
For BMS, the winning strategy was to play up their global leadership position in immuno-oncology. General Manager Cătălin Radu highlights, “BMS in Romania has a broad spectrum of immuno-oncology indications that include lung, renal, melanoma, head & neck and Hodgkin lymphoma in first-line or second-line treatment. Our products are considered to be the leader in the market. It is expected that our products shall be granted new indications and treatment lines. The big milestone this year will be a launch in first line renal cancer.”
The singular focus on immuno-oncology allows BMS to really drive stakeholder engagement. He illustrates, “in 2017, BMS was the first company in Romania to have a cost-volume agreement for immuno-oncology products, specifically for melanoma patients.” This has been recognized globally, as Radu celebrates, “in 2019, we received the Global Engagement Award for our innovative approach in bringing physicians in the community together. Continuous medical education is a key element where we are continuously innovating, [for instance], developing new interactive posters using QR codes and augmented reality.”
With the closing of the Celgene acquisition, BMS’ competences in oncology will only be amplified in the Romanian market. Radu predicts, “this positive momentum will continue. We want to continue to present the organisation as the most reliable partner in our field.”
On the other end of the spectrum is French giant, Sanofi. Romania and Moldova Country Chair Pascal Robin, who is also general manager for Sanofi Pasteur, underscores, “Sanofi is in a privileged position of having one of the most diversified portfolios in the market … with vaccines through Sanofi Pasteur, in specialty care (rare diseases, multiple sclerosis, oncology and immunology) with Sanofi Genzyme, in General Medicines (diabetes, cardiovascular solutions and established products) and in Consumer HealthCare, all of which are seeing sustainable growth.” For him, this explains the superior positioning of Sanofi as number two in the Romanian market compared to sixth globally. However, for those seeking to emulate this strategy, he cautions, “This diversification interacts differently in Romania compared to other European countries. The challenges of each business unit are not the same. The key challenge remains the same: maintaining agility and effectiveness.”
Nevertheless, regardless of portfolio breadth, having a direct presence is fundamental. Schalk Opperman, general manager of Merck Biopharma, illuminates, “historically Merck had sold its products through agents in Romania.” While the neurology, fertility and oncology franchises had all been reintegrated into the affiliate by 2013, Opperman’s major task when he assumed position in June 2016 was “to integrate the general medicine business into Merck Romania’s portfolio, which includes thyroid, diabetes and cardiovascular products. These medicines were present for 25 years before taken back.”
The results are clear, as he showcases, “when managed by an agent, it represented a small portion of Merck’s business. Today general medicine and endocrinology (GM&E) constitute 40 percent of the affiliate’s business [with] significant growth. [We] are currently assisting approximately 500,000 patients with their health needs every month.”
Beyond the portfolio, Jorge Levinson, head of pharmaceuticals for Bayer Romania and Moldova, swears on the value of building and leveraging the German brand, emphasizing, “Romanians know and appreciate the value behind the Bayer brand. The trust is based on our high-quality products and services, our open communication and high compliance standards. One of my internal priorities has been to ensure that Bayer provides the highest standards of service to healthcare professionals and partners. Science needs to transcend in discussions with healthcare stakeholders. We use state-of-the-art tools to provide accurate and agile information to the scientific community.” This also means investing in their employees so that they are “fully trained and knowledgeable about our medical specialties”.
He insists, “we want to keep enhancing the trust in Bayer – not only in general, but the trust of patients and physicians.” For him, personally, this is his third time leading an affiliate for Bayer, and he is driven by a personal sense of mission. He reveals, “I am excited about all the opportunities that Bayer has to offer. It personally motivates me to see that with our work, healthcare physicians can further access science to improve the life of many patients. It is gratifying to know that every day the quality of life of many can be improved thanks to our therapies.”
Finally, Novo Nordisk general manager Cecilia Radu offers an inspirational example that even a struggling affiliate can, with the right strategy, reverse its fortunes. She reveals, “after six years of declining market share and not providing new molecules to the market, in 2017 the organization started to grow anew.” She adds, “after 2019, the Romanian affiliate is considered to have the highest growth potential, as levels of diabetes care are still some of the lowest in the region; hence the big ambitions we have. Despite the delays with the product launches, the affiliate grew in high-single digits and grew in market share. Despite unfavourable odds Novo Nordisk grew, and this is setting us up for a good year ahead.”
Product Launch Strategy
From a commercial perspective, with so much uncertainty shrouding the external environment, the importance of a well-crafted product launch strategy cannot be underestimated, as the following experienced general managers share.
Merck General Manager Schalk Opperman contextualizes, “the environment changes continuously on a monthly or quarterly basis. Due to the unpredictable nature of the HTA approval process, it is difficult – if not impossible – to accurately predict when a product will be approved. My market access team must regularly adjust and recalculate pricing submissions as deadlines or legislations change continuously,” though as he admits, “this sharpens your scenario planning skills significantly! Speed is paramount for a successful launch.”
The struggle with their innovative multiple sclerosis product, Mavenclad®, is a case in point. Despite having been approved by the EMA in October 2017 and submitted for approval in Romania in November 2018, it still has not been approved. Opperman comments wryly, “the only benefit is that in the meantime, you have learned from other countries how patients and markets respond to [the] product.”
His tip? “Managing market expectations and properly allocating resources. The market needs to be prepared for launch yet at the same time not tired of hearing about the product or waiting too long for it.”
Dominika Kovacs, country manager of Takeda concurs on the need for speed. She reflects, “as we plan on introducing 11 new products within the next three years, we have elevated capabilities for launch excellence. Cross-functional readiness is a crucial factor. As soon as the reimbursement status is given, physicians and pharmacists should be able to order your products.”
The ultimate objective of any pharma company is to ensure that their medicines reach patients. This may seem like an uphill battle in Romania, considering the lengthy and unpredictable approval and reimbursement timelines – new drugs are only approved in Romania an average of 43 months after receiving European Medicines Agency (EMA) approval – but pharma affiliates in Romania continue to surprise and impress with their flexibility and ingenuity.
As Takeda Country Manager Dominika Kovacs phrases, “my purpose is to implement Takeda’s mission: securing access to our cutting-edge innovative portfolio. [We aim] to be flexible and find innovative ways to propose mutually beneficial solutions for patients while taking into consideration the legislative and budgetary restrictions of authorities.” As an example, reimbursement delays in their gastroenterology franchise did not stymie her. She illustrates, “the compelling need expressed by physicians and patient associations for inflammatory bowel disease (IBD) triggered Takeda to implement an early access program through donations. Where there is a will, there is way.”
She has also brought this winning attitude to the launch of their cutting-edge stem cell therapy, Alofisel®, the first of its kind to be approved in Europe. In this instance, she explains, “a pay-by-performance outcome-based model was not a good fit so we committed to assess patient outcomes case-by-case together with the National Health Insurance”, which proved crucial to enabling the upcoming launch of Alofisel® in May 2020. She concludes, “the only way to make a difference is through listening and [finding] mutual wins with various stakeholders [to achieve] momentum”.
Pfizer Country Manager Mirela Iordan echoes the necessity of being adaptable and proactive in terms of offering as many different solutions as possible. The Pfizer Care Program allows patients to receive access to innovative drugs through clinical trial programs under direct supervision by clinical investigators. She shares, “[while] there are certain legal mechanisms to facilitate access to innovations … when no bridging process can be found, Pfizer simply donates the medicines to hospitals that request it,”, adding that “half of Pfizer’s investments are done through donations to bring innovations to the patients.”
An example is their new-generation anti-coagulant Eliquis®, which, despite being one of the best-selling products in the world, is still not reimbursed in Romania after seven years. Iordan sighs, “patients must pay it out of pocket so [to help] Pfizer covers 40 percent of the treatment for a patient for five years through a co-payment system.”
To augment the strategic relevance of the Romanian market beyond the commercial, some multinationals have succeeded in building a compelling case for Romania to cassume regional responsibilities across a multitude of functions. Simona Cocos, general manager (Romania & Moldova) of pan-European consumer healthcare player Zentiva, underscores the importance of Romania as a manufacturing hub for the group: “the Romanian affiliate has a strong foothold in the region. Between 2013 and 2018, the company has invested more than EUR 19 million (USD 20.5 million) in the expansion of its production facilities. Last year, the company produced a record 105 million units, 4 million units more than the previous year.” She enthuses, “the majority of the production is exported to 29 different countries – a majority of them Western European – including the UK, France, Germany, Czech Republic, Russia and Belarus. The group has won four tenders in a row in Germany for metamizole, our pain molecule, which is produced in the Romanian factory.”
Pfizer Romania’s Mirela Iordan is also keen to play up the Romanian affiliate’s regional significance. “We promote Romania as a prime investment destination” she notes, “thus benefiting the local economy, ultimately increasing in time the country’s capacity to provide better care for its needy patients. We are proud that Romania has been selected by Pfizer to host two regional hubs which serve a third of the world in supply logistics services and rare diseases.”
The potential of Romania has been captured by service providers as well. As Cegedim General Manager Gabriel Cernica highlights, “Cegedim Group finds Romania a very attractive market and our activities here are well established. We strongly believe in the positive evolution of Romania. In recent years, we have invested a lot in Cegedim Customer Information and Cegedim Rx, as well as on a third new Cegedim company called Cegedim Service Centre – a business process outsourcing (BPO) company catering to our international affiliates – established in 2017, which already employs over 200 people in Romania – and expected to reach 300 in 2020.”
It is clear that there are significant benefits to participating actively in the region, as GSK General Manager Dana Constantinescu outlines, “Romania is part of the south-eastern region, representing 40 percent [of] the cluster’s business. The big advantage of this setup is the network. It allows GSK to share knowledge and resources, discuss challenges and import solutions from other markets.” At the same time, she notes, “it provides opportunities for upwards mobility – more than 40 Romanian colleagues have taken broader regional roles through the GSK network.”
Perhaps exceptionally, the OTC market in Romania is seeing healthy growth due to its relative insulation from regulatory turbulence – the clawback tax does not apply to this sector – and the positive trend in private healthcare consumption. Diana Mereu, executive director of the Romanian Association for the Self-Care Industry (RASCI), is convinced about the potential in and the necessity of the sector. She declares, “the Romanian healthcare system focuses on treatment rather than prevention. We are trying to shift this to prevention, which will consequently reduce healthcare costs as a whole – not only at an individual level.” At the same time, she cites, “the OTC medicine and supplements market is around 25 percent of the total drug market, a lot lower than the European average of 35-45 percent.”
However, even if the sector is fueled by out-of-pocket consumption, she does not want the OTC segment to be seen as low-hanging fruit. She stresses, “we hold ourselves accountable to the highest ethical standards. Our code of conduct includes guidelines which are not necessarily present in the local legislation [for companies] to promote their products in a responsible manner while educating the population in the correct usage of such products. As an association, we represent and help our industry members to promote a positive outlook of the industry and help consumers better understand the products we put in the market.”
Established nearly a century ago in 1921, local powerhouse Biofarm is one of the top five manufacturers of medicines in Romania. General Manager Cătălin Vicol sees ethics and commercial success as inextricably linked. He proclaims, “we have been here since 1921 and we are sure we will be here in another 100 years. We are not an opportunistic company.” For that reason, he elucidates, “we make sure that the promises we make to the consumers and healthcare professionals are supported by studies and the proven efficacy of our products, all of which are produced under GMP authorisation,” underlining, “we are one of the CHC players that invests the most in media campaigns, meaning that we have an active communication with our consumers to support their understanding of safe and responsible auto-medication.”
This has contributed to an increasingly more educated consumer market in Romania, which he deems extremely beneficial to the sector as well as the system as a whole. Vicol illuminates, “consumers have a better understanding of the need for responsible auto medication[, e.g.] many of them are aware of the fact that they do not need to go to the doctor as soon as they feel any minor symptom, which has a positive impact on the health budget and reduces the burden on hospitals.”
While a rising tide may lift all boats, Perrigo General Manager Fotis Kalantzis has his sights set on captaining the fleet. He exults, “in October 2019, Perrigo Romania received the IQVIA Award for “Best Performing Consumer Healthcare Company,” attributing this to two factors: a diverse and constantly updated portfolio and consumer communication. He shares, “a lot of investments are made in innovation [in terms of] launching new formulations to the market … to meet the demands of consumers. The organization benefits from a wide array of products across the globe, which can be selected and brought to Romania. [In addition] brand recognition and loyalty are very strong in Romania so one of the first things on my agenda was to implement a more consumer-centric approach in the market.” This effectively meant investing in both ‘above the line’ advertisement like TV and radio as well as digital channels to raise consumer awareness. With the affiliate leading in segments like cold and flu, vitamins and more niche categories like head lice products, the proof is in the pudding.
While Romania stands as the sixth most populous EU member country with over 19 million citizens, it suffers from perhaps one of the most insidious cases of ‘brain drain’, with over 3.5 million Romanians believed to be working in other EU countries. 2019 marked the second consecutive year that more Romanian babies were born outside the country than inside. This constitutes a thorny problem for the demands of the highly regulated pharmaceutical industry, with the task falling to general managers to oversee a comprehensive talent strategy to retain their employees.
Jorge Ruiz Benecke, general manager of AbbVie, reflects on his Romanian leadership journey: “as the general manager, I have the responsibility to foster an environment for employees to express [their opinions] freely, feel safe, experience new challenges and develop. Due to its history, Romania still follows hierarchical structures and mentality. From the first day, I explained to all AbbVie employees that the management team was here to serve them, to facilitate their work effectiveness and to create value. By injecting a sense of empowerment and trust into the middle management, the organisation started taking faster decisions. This had a positive effect [on employee morale] and boosted their confidence: together we built a culture that was recognized across all industries in Romania, when AbbVie was awarded the ‘Best Place to Work in 2019’ award.”
For Dana Constantinescu, the first Romanian to assume the position of general manager for GSK, the tone the GM sets is extremely important. She elucidates, “things move rapidly in Romania, and not everyone has access to the same information. I am very open with all my colleagues – not only the leadership teams – so that everyone is on the same page and feels included. People are the company’s biggest asset. There is an open-door policy for anyone who wants to discuss their [career development] pathway or needs advice.”
In the same vein, Norina Alinta Gavan, CEO of Wörwag, attributes the affiliate’s successful performance – 24th in the market with 1.1 percent market share – over the past 22 years to their unwavering commitment to finding and nurturing talent. She insists, “the team is the driving force behind the affiliate’s success. A lot of effort has been invested in finding the right people. I chose them based on chemistry and shared ambitions. I have placed a lot of emphasis on their happiness and on fostering their sense that this affiliate is their own company.” She adds, even when the organization went through an unavoidable restructuring in 2015 in response to the clawback tax and had to let go 25 percent of their medical reps, “within three months, 80 percent were employed by other pharmaceutical companies due to their quality.”
To build on this success, she previews, “in 2020, Wörwag is planning to launch a program in collaboration with the various Faculties of Pharmacy to find and develop talents for the industry. This program will serve not only as a gateway for students to discover new career opportunities but also elevate the profile of the pharmacist.”
While the forecast for 2020 remains uncertain for Romania as well as much of the world as the coronavirus crisis unfolds, it seems clear that as long as there remain a group of committed and dedicated healthcare leaders and stakeholders continuing to collaborate and invest in the country, there is hope for much-anticipated reforms across much of the healthcare value chain, be it market access or manufacturing, clinical research or hospital infrastructure.
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