“Palliative Care Legislation in Greece” – Opening Act
Aliki Tserkezoglou, Mary Dionisi
“Galilee” Palliative Care Centre, Spata, Greece
Received:13.01.2023
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December 21st, 2022. A day to remember for patients in need of Palliative Care and all other stakeholders in Greece. The Hellenic Parliament voted for the new law on the “Integrated System for the provision of Palliative Care”. This act, could be considered as the finishing line of a long advocacy course, but also as the starting point of a new marathon for the launching of regulatory acts necessary for its implementation.
“Palliative Care has a long history in Greece, yet it has not developed in line with other high-income countries in the European Union” 1.
At present there are only four services delivering Specialized Palliative Care in the country, serving a very small percentage of the 120,000 patients estimated to be in need per year. Three of these services care for adult patients offering care at home, in outpatient setting, Day Center and in one single available, 9-bed Inpatient Unit. The fourth service cares for children and adolescents at home.
All four specialized programs provide their services free of charge within the geographical area of Athens and its surroundings, thus leaving the needs of patients, in the rest of the country unattended. They operate on an unspecified regulatory status of “help at home” and cannot receive compensation from the national health care insurance agency, neither be supported by government funds, thus depending entirely on private and institutional donors. Moreover, they face challenges regarding the availability and prescription of some essential medicines, especially opioids and the lack of sufficient educational programs and accreditation for health care professionals. Nevertheless, for more than a decade, they have found ways to effectively operate, to raise public awareness about Palliative Care and most importantly to alleviate the suffering of their patients and families. At the same time, they have been advocating at a national level for Palliative Care policy development, mainly through lobbying with politicians and other decision makers.
This laborious and long-term effort led to the launching of the “National Committee for the development and implementation of a Palliative Care Strategy in Greece” in 2018 by the Ministry of Health. The Committee was kindly funded by the Stavros Niarchos Foundation with the purpose “to investigate and address the slow progress on Palliative Care development in Greece”1. The Committee consisted of 15 experts representing all relevant government agencies, the Academia, the palliative care providers and the patient organizations. Specialists from the Worldwide Hospice Palliative Care Alliance and the European Association for Palliative Care offered consultation.
The work of the Committee involved 3 stages. The first was the development of a feasibility study which explored the need for Palliative Care in Greece, assessed the capacity to deliver Palliative Care in the country, and put forward recommendations for overcoming barriers to Palliative Care development. Furthermore, a Palliative Care draft law was prepared for consideration by the Ministry of Health. The second stage elaborated the national strategy for developing Palliative Care in Greece over a 5-year period, while the third stage introduced the operational standards for the future implementation of the national strategy. After two-years of collaborative work, the Committee successfully concluded its tasks in 2020 and submitted the relevant documents to the Ministry of Health. Unfortunately, the proposed plan was bypassed at the beginning of 2020, due to the Covid-19 pandemic and the obvious priorities of the Ministry of Health.
Thus, within the next two years, a series of official letters, personal meetings, telephone calls etc., between many members of the Committee and decision makers or other stakeholders was conducted, to no avail. However, the experience of a big-scale, life-threatening situation as the Covid-19 pandemic put the spotlight on the benefits of Palliative Care and its principles.
Eventually at the very end of 2022, the aforementioned law on “Integrated System for the provision of Palliative Care”, consisting of 16 articles was passed. The law covers the general principles of Palliative Care and sets the stage for further regulatory acts that will be needed in order to enforce service provision. It mentions the definition, basic principle
and aims of Palliative Care, describes the different settings where it can be provided, reimbursement policies and staff training general requirements. Moreover, it determines the development of a patient registry and an advisory board of experts, a National Committee, which will consult the Central Board of Health and the Minister of Health.
The new law is definitely a breakthrough for our country. Nevertheless, there are some concerns, regarding conceptual issues, such as the distinction between General and Specialized Palliative Care and the predominance of doctors and nurses, contrary to other professional, in their representation in the National Committee. In addition, the arduous and time-consuming procedures determined by the law in order for interested stakeholders to be licensed, such as multiple Presidential, Ministerial and Inter-Ministerial decrees raise concerns regarding the time frame of their implementation.
Regardless of our justified concerns, it was delightful and rewarding to watch members of parliament (MPs), from different parties commenting on the indisputable value of Palliative Care and the need to develop such services at a national level. It was after a three-day session, in which MPs and the Palliative Care providers presented their arguments, that the first step towards the vision of accessible Palliative Care services for all patients in need, in Greece, was accomplished. The new law is a reality.
Looking back at all the efforts and the work accomplished, the authors feel that the opening act of “Palliative Care in Greece” has been successfully completed. At the same time a long and challenging route has just begun, for all Palliative Care stakeholders, in their quest for delivering as providers or accepting as patients or families in need, authorized, sustainable, high quality, hopefully free of charge palliative care services, which will alleviate suffering.
References
“Palliative Care Feasibility Study for Greece”, Ministry of Health, NATIONAL COMMITTEE FOR THE DEVELOPMENT & IMPLEMENTATION OF A PALLIATIVE CARE STRATEGY IN GREECE, 2019
- Law #5007, FEK #241/A/23.12.2022
THE PAINLESS project
María Teresa Carrillo-de-la-Peña, Noelia Samartin-Veiga
University of Santiago de Compostela, Spain
Received: 24.01.2023
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Cancer is one of the main causes of morbidity and mortality in the world. Its prevalence is very high: The International Agency of Research on Cancer estimated that in 2020 about 18.1 million cases were diagnosed worldwide, and its incidence is expected to increase in the coming years (https://gco.iarc.fr/). Cancer is associated with several physical consequences, of which one of the most distressing for patients is pain.
More than 50% of the oncological patients develop pain at some point before their death (Bruera, 2003; Swarm et al., 2019). It is estimated that 59% of patients under treatment for cancer, 64% of patients with advanced cancer disease and 33% of those cured, suffer from pain (van den Beuken-van Everdingen et al., 2007). However, 20% of these patients with oncological pain show a low response to pharmacological interventions (mostly using opioids) or have serious adverse effects. Thus, there is a need to explore alternative strategies to manage pain in patients with cancer. Although non-pharmacological invasive interventions such as neurosurgical procedures have been tested, they involve high risk for patients and big cost for the society (Bruera, 2003; Steinhauser, 2000). In recent years there has been a growing interest in neuromodulation treatments for the relief of a variety of chronic pain conditions. Among the neuromodulation techniques, transcranial Electrical Stimulation (tES) stands out for its low cost, ease of use and minimal side effects. The most studied tES in the management of pain is transcranial Direct Current Stimulation (tDCS) (Pinto et al., 2018). Transcranial Alternating Current Stimulation (tACS) has been less studied, but its preliminary results on pain relief are also promising (Ahn et al., 2019). Despite the likely benefits of tES in pain management, these techniques have been scarcely studied in cancer patients with pain.
The PAINLESS project was born in response to this reality. PAINLESS is funded by Horizon Europe and led by María Teresa Carrillo de la Peña (senior researcher of the University of Santiago de Compostela, Spain). The PAINLESS consortium is composed of 17 partners from 10 countries, with the representation of medical specialists in oncology and chronic pain, researchers in the field of pain and neuroscience, experts in health economics, as well as patient associations and small-medium enterprises.
The main goals of PAINLESS are (1) to develop a tool, based on the assessment of pain perception and modulation mechanisms and clinical variables, to predict the future occurrence of pain in patients with cancer; and (2) to adapt and test a novel, cost-effective, home-based intervention based on neuromodulation to reduce pain and improve the quality of life of patients with cancer suffering from chronic pain.
For this purpose, in PAINLESS project we designed 3 studies (see Figure 1). Study 1 will be a cohort, longitudinal study with 450 patients assessed in the first 6 months after their cancer diagnosis, and 6 and 12 months after this first evaluation. We will perform a comprehensive evaluation of the participants (using validated tests, quantitative sensory assessment and electroencephalographic recordings) and develop artificial intelligence algorithms to predict the occurrence of chronic pain using those biomarkers and clinical variables. Study 2 will have a cross-sectional design to characterize and stratify oncology patients, from a sample of 500 patients with pain and 250 without chronic pain. We will compare both groups using the same evaluation protocol as in Study 1 to better understand the mechanisms of pain perception and modulation in oncological pain. Study 3 will be conducted to assess the feasibility and efficacy of at-home delivery of transcranial low intensity electric stimulation treatment (tES) for the palliative care of cancer patients suffering from pain. It is a Randomized Control Trial (RCT) with 450 oncological patients with chronic pain. The PAINLESS proposed treatment will consist of 15 – 20 minute sessions of tDCS or tACS that the patients will administer themselves from home. The researchers in charge will remotely monitor the whole process. To evaluate the effect of the treatment, evaluations will be carried out before and after tES, and at 3 and 6 months of follow-up.
Moreover, to ensure the impact of PAINLESS we will (1) develop a customized web portal to share knowledge on cancer pain and to improve management of the patients; (2) perform techno-economic analyses and Health Technology Assessment of the proposed protocol to assess and manage oncological pain and analyze the possibilities of implementation in different European healthcare systems (after assessment of regulatory barriers).
The PAINLESS project has been running since June 2022 and we are currently finalizing the details to start collecting data for the first study in 4 clinical units across Europe (Spain, Portugal, Denmark, and Romania).
Overall, the three PAINLESS studies will improve our understanding of the mechanisms of oncologic pain and will allow us to assess the effectiveness of a truly interdisciplinary approach to improving pain management in palliative care programs across Europe.
Figure 1. Infographic of the 3 studies that compose the PAINLESS project.
References
- Ahn, S., Prim, J. H., Alexander, M. L., McCulloch, K. L., & Fröhlich, F. (2019). Identifying and Engaging Neuronal Oscillations by Transcranial Alternating Current Stimulation in Patients With Chronic Low Back Pain: A Randomized, Crossover, Double-Blind, Sham-Controlled Pilot Study. The Journal of Pain, 20(3), 277.e1-277.e11. https://doi.org/10.1016/j.jpain.2018.09.004
- Bruera, E. (2003). Cancer Pain. JAMA, 290(18), 2476. https://doi.org/10.1001/jama.290.18.2476
- Pinto, C. B., Teixeira Costa, B., Duarte, D., & Fregni, F. (2018). Transcranial Direct Current Stimulation as a Therapeutic Tool for Chronic Pain. The Journal of ECT, 34(3), e36-e50. https://doi.org/10.1097/YCT.0000000000000518
- Sociedad Española de Oncología Médica. (2022). Las cifras del cáncer en España 2022. https://seom.org/images/LAS_CIFRAS_DEL_CANCER_EN_ESPANA_2022.pdf
- Steinhauser, K. E. (2000). Factors Considered Important at the End of Life by Patients, Family, Physicians, and Other Care Providers. JAMA, 284(19), 2476. https://doi.org/10.1001/jama.284.19.2476
- Swarm, R. A., Paice, J. A., Anghelescu, D. L., Are, M., Bruce, J. Y., Buga, S., Chwistek, M., Cleeland, C., Craig, D., Gafford, E., Greenlee, H., Hansen, E., Kamal, A. H., Kamdar, M. M., LeGrand, S., Mackey, S., McDowell, M. R., Moryl, N., Nabell, L. M., … Gurski, L. A. (2019). Adult Cancer Pain, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. Journal of the National Comprehensive Cancer Network, 17(8), 977-1007. https://doi.org/10.6004/jnccn.2019.0038
- van den Beuken-van Everdingen, M. H. J., de Rijke, J. M., Kessels, A. G., Schouten, H. C., van Kleef, M., & Patijn, J. (2007). Prevalence of pain in patients with cancer: A systematic review of the past 40 years. Annals of Oncology, 18(9), 1437-1449. https://doi.org/10.1093/annonc/mdm056