The document discusses the complex history and regulations around drug approval and patient access in Europe, highlighting issues like the need for harmonization across countries and rising drug costs putting pressure on health budgets. It also provides an example of how patient advocacy groups like Myeloma Patients Europe work to monitor access barriers in different countries and support national organizations in addressing issues around timely access to new treatments.
March 02, 2018
Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.
To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborated with Ropes & Gray LLP to host a one-day conference on value-based health care. This event brought together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/will-value-based-care-save-the-health-care-system
March 02, 2018
Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.
To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborated with Ropes & Gray LLP to host a one-day conference on value-based health care. This event brought together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.
For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/will-value-based-care-save-the-health-care-system
The role of real world data and evidence in building a sustainable & efficien...Office of Health Economics
This presentation defines RWD and RWE in the context of digital health, and looks at potential uses for RWD and RWE. It briefly sets out the current landscape in Malaysia and looks at the challenges in using RWE. In particular, the issues of access, governance and ensuring good quality are considered.
The future of patient data the danish perspective 2018Future Agenda
The Danish perspective on implications from the future of patient data - insights from discussions in Copenhagen
Denmark is recognised as one of the leading nations for healthcare and is at the forefront of digital transformation in the sector. As new challenges and opportunities emerge over the next decade this article considers what the core drivers of change may be and explores how developments in the availability and use of more and better patient data may impact the Danish health system. Linking together previous research, a recent related Future Agenda initiative and insights from a number of expert discussions in Copenhagen, it then examines the pivotal issues that will affect healthcare providers in the future and considers how the wider sharing of exemplary data can change delivery models.
Given the overall dynamics, many conclude that Denmark is one of the most connected, well-funded and healthy nations in the world. The advent of more and better health data should therefore have additional impact. So, what about the future? How will the global changes underway impact and enhance the Danish system? Moreover, what will be the national vs regional response?
A recent global project exploring the future of patient data was undertaken by Future Agenda in partnership with leading organisations around the world. (www.futureofpatientdata.org) Twelve events across many different healthcare systems brought together over 300 experts to debate the primary shifts for the next decade as well as explore their implications. Within this, several shared ambitions in a number of different countries were identified – many of which can already be seen as existing assets of the Danish system: Good quality patient data, common access to it, and means of interacting with both the information and the different communities who form the full care system.
As the first phase of a subsequent series of more regional, national dialogues, in June 2018 additional discussions were undertaken with healthcare experts in Copenhagen to uncover more detail. Hosted by DTU Business, the aim was to both respond to the global context from the Future of Patient Data project and debate what the implications may be for Denmark. In particular, a core objective was to identify what are the primary issues for the Danish healthcare system for the next decade.
mHealth Israel_Mony Weschler_Montefiore_How Data Exchange Is Essential In Sup...Levi Shapiro
Presentation for mHealth Israel by Mony Weschler, Senior Director Applications Strategy and Innovation, Albert Einstein College of Medicine, Montefiore Medical Center. Theme: How Data Exchange Is Essential In Support of New Technologies & Healthcare Innovation. This presentation has three objectives:
1) Discuss IT governance components that positioned Montefiore to achieve extensive community outreach efforts
2) Review strategies for incorporating innovation and new technologies into existing processes.
3) Identify the data exchange challenges
What's Next in RWE_Amy Rudolph_Novartis_mHealth IsraelLevi Shapiro
Overview of the
- Healthcare ecosystem complexity increasing rapidly
- Pharma industry is facing a crisis: trends shaping the industry
- RWE complements RCTs and captures implementation of innovation
- RWE is one component of the integrated evidence needed for stakeholders
- Integrated Evidence: Optimizing patient access
- Integrated Evidence: Label expansion
- Maximizing the value of data requires a scalable platform and expertise
UCD Rare Disease Module 2017 - Dr Derick Mitchell - March 28th 2017ipposi
Medical students taking the elective course in rare diseases are provided a number of patient perspectives throughout the module. This is what IPPOSI presented in 2017.
EuroBioForum 2013 - Day 2 | Rachael RitchieEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# REGIONAL PERSPECTIVES #
Genome British Colombia, Canada:
Regional Perspectives on Personalized Medicine in British Columbia, Canada
Dr Rachael Ritchie
Director Business Development Genome British Colombia
=======================================
http://www.eurobioforum.eu
Long-term care: Integrating health and social care -- Tim Muir, OECDOECD Governance
This presentation was made by Tim Muir, OECD Secretariat, at the 6th Meeting of the Joint OECD DELSA-GOV Network on Fiscal Sustainability of Health Systems, held at the OECD Conference Centre, Paris, on 18-19 September 2017
Peter L. Slavin, M.D., 2015 Leadership in Academic Medicine Lectureuabsom
Peter L. Slavin, M.D., president of Massachusetts General Hospital, presented “The Future of Academic Medicine” on Thursday, Aug. 6 as the featured speaker for the 2015 Leadership in Academic Medicine Lecture, sponsored by UAB Medicine.
The patient voice: turning health policy into opportunity - Jan Geissler - ES...patvocates
Presentation on how the patient voice can turn health policy into advocacy opportunities to improve the life of patients. Presented by Jan Geissler, Co-founder of CML Advocates Network, at the Patient Seminar of the European Society of Gynaecological Oncology (ESGO) in Liverpool on 19 Sept 2013
The role of real world data and evidence in building a sustainable & efficien...Office of Health Economics
This presentation defines RWD and RWE in the context of digital health, and looks at potential uses for RWD and RWE. It briefly sets out the current landscape in Malaysia and looks at the challenges in using RWE. In particular, the issues of access, governance and ensuring good quality are considered.
The future of patient data the danish perspective 2018Future Agenda
The Danish perspective on implications from the future of patient data - insights from discussions in Copenhagen
Denmark is recognised as one of the leading nations for healthcare and is at the forefront of digital transformation in the sector. As new challenges and opportunities emerge over the next decade this article considers what the core drivers of change may be and explores how developments in the availability and use of more and better patient data may impact the Danish health system. Linking together previous research, a recent related Future Agenda initiative and insights from a number of expert discussions in Copenhagen, it then examines the pivotal issues that will affect healthcare providers in the future and considers how the wider sharing of exemplary data can change delivery models.
Given the overall dynamics, many conclude that Denmark is one of the most connected, well-funded and healthy nations in the world. The advent of more and better health data should therefore have additional impact. So, what about the future? How will the global changes underway impact and enhance the Danish system? Moreover, what will be the national vs regional response?
A recent global project exploring the future of patient data was undertaken by Future Agenda in partnership with leading organisations around the world. (www.futureofpatientdata.org) Twelve events across many different healthcare systems brought together over 300 experts to debate the primary shifts for the next decade as well as explore their implications. Within this, several shared ambitions in a number of different countries were identified – many of which can already be seen as existing assets of the Danish system: Good quality patient data, common access to it, and means of interacting with both the information and the different communities who form the full care system.
As the first phase of a subsequent series of more regional, national dialogues, in June 2018 additional discussions were undertaken with healthcare experts in Copenhagen to uncover more detail. Hosted by DTU Business, the aim was to both respond to the global context from the Future of Patient Data project and debate what the implications may be for Denmark. In particular, a core objective was to identify what are the primary issues for the Danish healthcare system for the next decade.
mHealth Israel_Mony Weschler_Montefiore_How Data Exchange Is Essential In Sup...Levi Shapiro
Presentation for mHealth Israel by Mony Weschler, Senior Director Applications Strategy and Innovation, Albert Einstein College of Medicine, Montefiore Medical Center. Theme: How Data Exchange Is Essential In Support of New Technologies & Healthcare Innovation. This presentation has three objectives:
1) Discuss IT governance components that positioned Montefiore to achieve extensive community outreach efforts
2) Review strategies for incorporating innovation and new technologies into existing processes.
3) Identify the data exchange challenges
What's Next in RWE_Amy Rudolph_Novartis_mHealth IsraelLevi Shapiro
Overview of the
- Healthcare ecosystem complexity increasing rapidly
- Pharma industry is facing a crisis: trends shaping the industry
- RWE complements RCTs and captures implementation of innovation
- RWE is one component of the integrated evidence needed for stakeholders
- Integrated Evidence: Optimizing patient access
- Integrated Evidence: Label expansion
- Maximizing the value of data requires a scalable platform and expertise
UCD Rare Disease Module 2017 - Dr Derick Mitchell - March 28th 2017ipposi
Medical students taking the elective course in rare diseases are provided a number of patient perspectives throughout the module. This is what IPPOSI presented in 2017.
EuroBioForum 2013 - Day 2 | Rachael RitchieEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# REGIONAL PERSPECTIVES #
Genome British Colombia, Canada:
Regional Perspectives on Personalized Medicine in British Columbia, Canada
Dr Rachael Ritchie
Director Business Development Genome British Colombia
=======================================
http://www.eurobioforum.eu
Long-term care: Integrating health and social care -- Tim Muir, OECDOECD Governance
This presentation was made by Tim Muir, OECD Secretariat, at the 6th Meeting of the Joint OECD DELSA-GOV Network on Fiscal Sustainability of Health Systems, held at the OECD Conference Centre, Paris, on 18-19 September 2017
Peter L. Slavin, M.D., 2015 Leadership in Academic Medicine Lectureuabsom
Peter L. Slavin, M.D., president of Massachusetts General Hospital, presented “The Future of Academic Medicine” on Thursday, Aug. 6 as the featured speaker for the 2015 Leadership in Academic Medicine Lecture, sponsored by UAB Medicine.
The patient voice: turning health policy into opportunity - Jan Geissler - ES...patvocates
Presentation on how the patient voice can turn health policy into advocacy opportunities to improve the life of patients. Presented by Jan Geissler, Co-founder of CML Advocates Network, at the Patient Seminar of the European Society of Gynaecological Oncology (ESGO) in Liverpool on 19 Sept 2013
UNITAID's Brenda Waning Presentation at the UNITAID/UNAIDS/Medicines Patent Pool Side Event,
United Nations High Level Meeting on AIDS
New York
9 June, 2011
EuroBioForum 2013 - Day 1 | Emmanuelle BenzimraEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# MARKET PERSPECTIVES #
Navigating the Challenges of Personalised Medicine Access in Europe
Emmanuelle Benzimra
General Delegate at EPEMED, The European Personalised Medicine Association
=======================================
http://www.eurobioforum.eu
Graham was invited to the weekly seminar series by the Royal Brompton Hospital to deliver a presentation on health economics pertinent to Respiratory medicine. They care for a large number of patients with complex lung diseases at the institution and juggle the varied issues of resource (human, structural or financial). As one of many examples, high cost drugs for treating relatively unusual conditions comes up for debate all too frequently. The audience included consultant physicians, senior and junior trainees, nurses and other allied health professionals.
Date: 7 March 2019
Location: The Royal Brompton, London, UK
The benefits of patient involvement in research and development (RE:ACT Congr...jangeissler
Presentation of Jan Geissler, Director EUPATI and Co-Founder CML Advocates Network, about the benefits of involving patients in research and development, and about EUPATI. Held at RE:ACT Conress 2016 on Research of Rare and Orphan Diseases, organized by the Blackswan Foundation on 12 March 2016 in Barcelona, Spain
The World’s Health Care Crisis: From the Laboratory Bench to the Patient’s Be...Elsevier
Ibis Sánchez-Serrano, founder and CEO of The Core Model Corp., a corporate strategy and policy think tank, talks about the role of pharma in the World’s Health Care Crisis at the New York Public Library on Aug. 29, 2013. He says the major problem is lack of access to better, safer and more affordable medicines. This issue is present not only in the United States and the developing world but also in countries with socialized health care systems. This illustrated talk will provide a comparative analysis of healthcare systems throughout the world and address major issues within biotechnology and pharmaceutical industries.
Merck: Global Health and Access to MedicinesTony Sebastian
This is a HBR case study analysis of Merck, the pharmaceutical company. Detailed analysis of the issues are given in the case like CAGR framework, PESTAL, SWOT etc
How Effective is the Public in Influencing HTA Decisions?Kathi Apostolidis
Patients should be involved in HTA process to assure a robust process that embraces patients' needs, preferences, perspectives. ECPC-European Cancer Patient Coalition leverages on European Institutions for a solution to the timely authorization and reimbursement of innovative cancer medicines
Ariane Weinman presents at ESMO 2021 on how the integration of a specific section on rare cancers into NCCPs can support patients' from diagnosis to treatment
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Basavarajeeyam - Ayurvedic heritage book of Andhra pradesh
0106 David Haerry - Regulatory system
1. Regulatory systems & access
Why is it an issue, why is it complex?
David H.-U. Haerry, EUPATI
david@haerry.org
2. Regulatory system, history
Until Thalidomide scandal, all new medicines were considered “beneficial”
Thalidomide
• Developed 1950s, marketed as mild sleeping pill
• Considered safe for pregnant women, prescription free over-the-counter (OTC)
• Thousands of babies born with malformed limbs, damage revealed in 1962, drug taken off market
• Scandal led to tough testing & drug approvals by global regulators
• Thalidomide later seen as beneficial (leprosy, some cancers)
1960s, 1970s: rapid increase in laws, regulations & guidelines for reporting & evaluating data on
safety, quality & efficacy of new medicinal products
Industry more international, but different requirements in every country challenging
Need for regulatory requirements harmonisation pioneered by EC in 1980s, as Europe planned
moving to a single market. International Committee for Harmonisation ICH created April 1990
ICH is setting global standards. Members: https://www.ich.org/about/members-observers.html
1995: EMA created as collaboration of European regulatory bodies to assess efficacy & safety
of human and veterinary medicines in Europe via centrally authorised procedure
https://www.ema.europa.eu/en/about-us/what-we-do
12/07/2019 2
3. EU marketing authorisation procedures
12/07/2019 3
Different actors are involved in the marketing authorisation of a medicine depending on which
procedure the sponsor opts or is obliged to follow.
4. EU central medicine authorisation procedures
12/07/2019 4
The centralised procedure used to authorise a medicine in all EU and EEA countries
CP = Central Procedure
EMA = European Medicines Agency
CHMP =Committee for Medicinal Products for Human Use
EC = European Commission
5. Scope of the centralised authorisation procedure
12/07/2019 5
The centralised procedure is compulsory for
Human medicines containing a new active substance to treat:
• human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
• cancer;
• diabetes;
• neurodegenerative diseases;
• auto-immune and other immune dysfunctions;
• viral diseases.
Medicines derived from biotechnology processes, such as genetic engineering;
Advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-
engineered medicines;
Orphan medicines (medicines for rare diseases);
Veterinary medicines for use as growth or yield enhancers.
6. Scope of the centralised authorisation procedure
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The centralised procedure is optional for other medicines:
Containing new active substances for indications other than those stated above;
That are a significant therapeutic, scientific or technical innovation;
Whose authorisation would be in the interest of public or animal health at EU level.
Today, the great majority of new, innovative medicines pass through the
centralised authorisation procedure in order to be marketed in the EU.
7. Health Technology Assessment, history
Until 1970s, all new medicines were considered “affordable & ok to reimburse”.
Systematic HTA development from 1976, report by U.S. Office of Technology Assessment
Spread to Europe 1980 (Swedish Council on Technology Assessment in Healthcare (SBU)
HTA has spread all over Europe, also Latin America & Asia. Exceptions: CH
Consensus development since 1977 (NIH)
• Physicians, researchers, economists, epidemiologists, consumers / patients, ethicists to seek consensus on
• Safety, efficacy, appropriate conditions for use
Problems
• Reimbursement impact on national health budgets
• Every country uses its own system, little harmonisation, no centralised procedure
• Duplication with regulatory process
• Can be misused to delay access
• Patient engagement poor, resulting in little user impact on decision making
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8. Access issues – a global perspective
Todays system relies on U.S. market paying “any price”, and Western European
countries paying very high prices
No transparency on prices agreed & paid at national level (except Switzerland)
Awkward Hollywood style blockbuster model – success pays for failures, no
consideration of development cost
Consumers / patients only concerned about access, with little consideration about
prices & affordability
Industry’s main concern is turnover & shareholder value. Often short sighted
perspective, driven by stock market expectations & quarterly reporting
Systems see healthcare as expense, not an investment
Fears on all sides drive prices up
Only fragmentary use of outcomes data
Overall, a very ineffective system with little motivation to change – too many parties
prefer maintaining “the devil they know”
12/07/2019 8
9. Access problems increasing in many indications
Rare diseases – specific legislation and high unmet medical need made many
companies to invest in research
• In the past, richer health systems reimbursed drugs without big resistance. Few people
affected make little difference on the system as a whole.
• However, there are 7-8’000 rare diseases, ca 7% of population affected, overall disease
burden higher than diabetes (Source: National strategy for rare diseases, Switzerland)
• Issue: price, plus ethical dilemma
New mechanisms of action: Gene therapy
• We have a price model for controlling chronic diseases requiring life-long treatment, but not
for single application therapies like CAR-T cell therapy
• Economics of precision medicines not understood
• Can usual economic models be used?
• Does is require fundamental transformation, or a second parallel system, with innovation in
business, cost & payer models?
12/07/2019 9
Issue: on first sight price,
in reality a lot more complex
10. Access problems increasing in many indications
Antibiotics
• Generic antibiotics became so cheap that they are delisted in many countries – Switzerland
has no cure for syphilis
• New antibiotics, much needed to overcome increasing resistance, used as treatment of last
resort: very expensive to payers, few prescriptions, bad business for industry
• Issue: Prices too low, or prescriptions so rare, orphan medication
Hepatitis C – complex viral disease with heavy disease burden in some
countries
• Biggest scientific progress in 21st century
• First line cure rates 98% within 8-12 weeks, without side effects, up from 35-50% within 9
months & heavy side effects 5 years ago
• Nobody expected reimbursement problems
• Almost every country delayed access. Easy cure also means more prescriptions!
12/07/2019 10
Issue: health budget impact
11. Access problems increasing in many indications
Cancer therapies – many issues come together
• Many types of cancer, some rare
• A lot of progress in some areas (breast cancer, childhood cancer)
• Combination therapies increasingly understood as effective – impact on prices
• Precision medicines & single gene therapies on the horizon
• Issue toxic cocktail: high prices, impact on QALY questioned, ethical dilemma, high
unmet need
Systems are built for past requirements and take time to adopt change
• The faster technology progresses, the bigger the gap between what is scientifically possible
and what is accessible via health systems
Ethically devastating impact on patients who know there is a treatment around
the corner, but access is not fixed
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Issue: static systems
12. How can patient organisations cope with this?
European level - EMA
• European regulator has systematically involved patients in its decision making since 1996
• Patient engagement happens within a thorough framework of interaction
• EMA interacts with European organisations qualifying as “eligible organisations”
• Bigger umbrella organisations are members of the Patient & Consumer Working Party
PCWP
Challenge: Access issues are national, not European
• Access barriers differ from country to country. In some countries, barriers may be regional
(UK, Spain)
Some, but not all indications / disease groups have built a strategy
Effective access advocacy requires
• Monitoring, European coordination, communication & information exchange
• A lot of leg work at national level
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13. Example: Myeloma Patients Europe (MPE)
MPE: umbrella organisation representing
myeloma and AL amyloidosis patient groups
• 43 member organisations
• 28 European countries and beyond (Russia, Turkey,
Israel)
• MPE providing a range of programmes & resources
aimed at building a strong European advocacy
community
MPE recognises
• Challenges & barriers differ from country to country
• GDP differences
• Resource differences
• Health system differences
12/07/2019 13
Slide courtesy MPE
14. Example: Myeloma Patients Europe (MPE) – CEE region
12/07/2019 14
Limited GDP and
expenditure on
healthcare
Affordability of
new and upcoming
medicines
Systemic
government and
infrastructure
challenges
Unequal access to
procedures and
diagnostics
Off-patent medicines
not reaching
patients (e.g. Balkan
countries)
Clinical trials not
launching in some
countries
Complex, expensive
myeloma pathway
Slide courtesy MPE
15. MPE Access survey 2017 – 2018
Does country have at least one of the ESMO recommended treatments
per specific phase?
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Country Columna2
Average time
between
onset and
diagnosis
Overall rating
of diagnosis
standards
C
o
l
u
m
n
a
3
Initial
treatment for
patients elegible
for stem cell
transplantation
Maintenance
therapy
following ACT
Initial
treatment for
patient inelegible
for stem cell
transplantation
First relapse
after a
lenalidomide or
thalidomide
based initial
treatment
First relapse
after bortezomib-
based initial
treatment
Second stem
cell
transplantation
Second or
subsequent
relapse
Overall rating
of treatment
standards
Columna1
Multiple
myeloma
crude rate
(2018)
Multiple
myeloma age-
specific rate
(ASR,
European
new) (2018)
Health
expenditure
in US$ PPP
per
inhabitant
(2014)
Luxembourg 1 9 Yes Yes Yes Yes Yes Yes Yes 10 6,4 8,1 6812
Switzerland 2 10 Yes Yes Yes Yes Yes Yes Yes 10 7,9 8 6468
Norway 2 8 Yes Yes Yes Yes Yes
Only for specific
situations
Yes 8 8,9 10,1 6347
Sweden 1 No data Yes Yes Yes No Yes Yes Yes No data 8,2 8,2 5219
Netherlands 2 7 Yes Yes Yes Yes Yes Yes Yes 8 6,9 7 5202
Germany 2 9 Yes Yes Yes Yes Yes Yes Yes 9 8,7 7,6 5182
Austria 1 8 Yes Yes Yes Yes Yes Yes Yes 8 6,4 6,2 5039
Denmark 2 7 Yes Yes Yes Yes Yes Yes Yes 9 6,5 6,5 4782
Finland Don't know 9 Yes Yes Yes Yes Yes Yes Yes 9 8,5 8 3701
United Kingdom (England) 2 7 Yes No Yes Yes No Yes Yes 8 10,1 10,6 3377
United Kingdom (Scotland) 2 7 Yes No Yes Yes Yes Yes Yes 8 10,1 10,6 3377
Italy 1 8 Yes Yes Yes Yes Yes Yes Yes 9 10,2 8,6 3239
Malta 1 9 Yes Yes Yes Yes Yes Yes Yes 7 6,9 7,1 3072
Spain 1 8 Yes Yes Yes Yes Yes Yes Yes 9 7 6,7 2966
Slovenia 2 10 Yes Yes Yes Yes Yes Yes Yes 10 7 6,7 2698
Israel 3 7 Yes Yes Yes Yes Yes Yes Yes 9 2599
Slovak Rep. 3 7 Yes Yes Yes Yes Yes Yes No 5 6,8 8 2179
Czech Republic 2 7 Yes No Yes Yes Yes Yes Yes 7 5,3 5,4 2146
Cyprus 1 7 Yes No Yes Yes Yes Yes No 6 4,8 6,5 2062
Russia 3 7 Yes Yes Yes Yes Yes Yes Yes 9 1836
Hungary 2 8 Yes No Yes Yes Yes
Only for specific
situations
Yes 6 4,6 4,6 1827
Lithuania 2 8 Yes No Yes Yes Yes Yes Yes 8 6,2 6,1 1718
Bulgaria 3 8 Yes No Yes Yes No Yes Yes 7 2,3 2,1 1399
Serbia 2 9 Yes No Yes Yes Yes Yes Yes 8 1312
Romania 2 3 Yes No Yes Yes No Yes Yes 3 3,3 3,4 1079
Latvia 2 7 Yes No Yes No No Yes No 5 5,2 5 940
Macedonia 2 5 No No Yes No No Yes Yes 4 851
Slide courtesy MPE
16. Role of European umbrellas in access
Identify access barriers via ongoing survey
• Monitor
• Gather evidence
• Escalate if several countries affected by same barrier
Collaborate with industry
• Trial design, trial roll-out
• Create awareness about access barriers
Keep close contact with national organisations
• Maintain structured exchange between national & umbrellas
• Umbrellas need to understand national access barriers to act as
advocates at European level
• Identify access topics, trends & promote information sharing
• Organise access advocacy capacity buildings
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Slide courtesy MPE
17. The MPE cookbook
Monitor & influence national access to myeloma
and AL amyloidosis drug by collaborating with
stakeholders
Bi-annual survey to monitor access barriers
Information exchange with members & clinicians
Use external meetings & congresses
Information exchange with other European PAGs,
coalitions & professional societies
Represent interests in steering groups &
roundtables
Maintain access dialogue with industry
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Slide courtesy MPE
18. Identify access challenges & develop solutions
MPE Access Atlas Programme providing
information & support to members
Monitor & escalate cross cutting access
themes at European level
Access Coaching Programme providing
personal support to members working on
access at national level
• Responding to requests for general help or
strategy development
• Provide support on access issues
• Intervene when appropriate
12/07/2019 18
Slide courtesy MPE
19. Examples of MPE support
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Romania: Issues with access to stem cell
transplantation
Croatia: Information provision to support work on
medicines access and drug shortages
North Macedonia: Access to generic bortezomib
Finland: Support in case building for two new
medicines going through HTA
Poland: Individual patient support & support on
access to novel agents Slide courtesy MPE
21. Group work – 9 groups
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9 break out groups
• Russia (3 people)
• Greece, North Macedonia & Croatia (5 people)
• 2 groups Italy & Spain (2 group, 5 people each)
• Finland (4 people)
• Georgia, Poland, Ukraine (4 people)
• UK, Ireland (4 people)
• Norway, Switzerland, Iceland (5 people)
• Germany, France, Netherland (4 people)
Task: in 30 minutes, list access barriers in their country & propose activities to
address these barriers
4-5 groups to present their findings in the last 30 minutes