Daily Answer Writing
03 April 2021

Q) Given the constrained fiscal position, it is difficult for the government  to focus on particular diseases rather than Universal health. In this context analyse the National Policy for Rare Diseases, 2021. (150 Words)
Source: <https://www.thehindu.com/news/national/disquiet-over-govts-new-policy-for-rare-diseases/article34225606.ece>
GS 2: Health

Approach Answer:

 

Introduction: Rare Disease is a health condition of low prevalence, affecting a small number of people, as compared to other prevalent diseases in the general population. WHO defines it as an often debilitating lifelong disease or disorder condition with a prevalence of less than 1 per 1000 persons, and thus are difficult to focus on.

 

However, different countries have their own definitions. Despite being less prevalent and individually rare, collectively they affect between 6% and 8% of total population in any country. Thus it is necessary to have a comprehensive policy in this regard. Draft National Policy for Rare Diseases is recently formulated by the Ministry of Health and Family Welfare.

 

Despite fiscal and focal constraints it makes following progress :

               1. Categorization of diseases for greater focus: It creates three categories of rare diseases-

                              1. diseases requiring one-time curative treatment,

                              2. diseases which need long-term treatment, but cost is low,

                              3. diseases that require life-long treatment and cost is high.

               2. National Registry for Rare Diseases will be created at ICMR

               3. Definition Problem: ICMR will help to arrive at a definition of rare diseases, best suited to India.

               4. Financial support for treatment: For BPL(Below Poverty Line) under existing Rashtriya Arogya Nidhi,  and one-time treatment cost to the tune of ?15 lakh under Ayushman Bharat/ Pradhan Mantri Jan Arogya Yojana, which covers 40% of the population.

               5. Awareness generation: developing materials for generating awareness in the general public, patients and their families and for training of health care providers.

               6. Standardized Protocol Development: Develop standardized protocols for diagnosis and treatment/management of rare diseases, to be revised in conformity with evolving diagnosis and treatment landscape  and rolling out testing for rare genetic diseases in newborns.

               7. Strengthen laboratory networks for diagnosis of rare diseases. Accredit centres for diagnosis and treatment of rare diseases which could be developed as Centres of Excellence (CoE) over a period of time, in a phased manner

               8. Studies & Research: Conduct epidemiological studies to estimate prevalence of rare diseases. Take measures to improve R&D for treatment, diagnostic modalities, care and support including assistive devices, drug development for rare diseases etc.

               9. Legal & Other Measures to enhance access to Treatment: Drug Controller General of India (DCGI) to consider feasibility of amending Drugs and Cosmetics Act or otherwise taking measures under it, to include appropriate provisions on drugs for rare diseases, including provisions to facilitate clinical trials and import of ERTs, to improve cheap local manufacturing of such orphan drugs.

               10. Sustainable Funding Measures:  Encourage funding support from PSUs and corporate sector, ensuring insurance coverage for rare genetic disorders, allow imports of Enzyme Replacement Therapies (ERTs) and remove import duty on them as well as on assistive devices. Further, Creating a National and State Level Corpus with the ratio of 60:40.

              

Limitations and Challenges:

               1. No clear roadmap: It lists 450 diseases as rare but does not provide a detailed roadmap on treatment.

               2. Limited Financial support: Not even half of the population covered through Ayushman Bharat. Rashtriya Arogya Nidhi gives only one time ?15L grant which is insufficient in most of the cases. There is no clarity of Centre and State responsibilities and on patients not covered in above schemes.

               3. Source of Funding: Only 100Cr annual Budgetary is recommended in a policy. To cover limited funding it recommends crowd funding as a source to fund treatment of rare diseases and advises hospitals to report such cases on digital platforms to gather funds. This is not a sustainable option.

               4. No treatment for GROUP 3 PATIENTS:  The new policy has absolutely no consideration for Group 3 patients, who require lifelong treatment support.

               5. No solution for many patients waiting treatment: It offers no support to patients awaiting treatment since the earlier National Policy for Treatment of Rare Diseases 2017 was kept in abeyance.

               6. Implementation mechanism: It mandates formation of a standardized protocol, but fails to provide one in the policy itself.

              

Conclusion: The new policy does a great job in touching the root cause of the problem, i.e. failure to identify rare conditions before birth, and lack of research in the field. If the causes are identified, it would prevent a great loss to the families and nation. However, the greatest challenge that it faces is the funding, given that being a developed country, India faces far dangerous diseases with much higher prevalence and cost to the nation.

 

In this context, ensuring mandatory coverage of rare diseases in the health insurance products can go a long way, as best Insurance products is designed for rare occurrence high impact events.

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