Kerala High Court Issues Directions To Regulate Crowd Funding For Treatment Of Rare Diseases

The Kerala High Court has issued a set of directions to the State and the Central governments in an attempt to make available adequate funds for treating patients suffering from rare diseases, particularly for those who cannot afford such expenses, to enforce the rights guaranteed to the citizens under Article 21 of the Constitution. 

Justice P.B. Suresh Kumar directed the Centre and State to file affidavits within a month indicating inter alia the progress of the crowdfunding scheme sought to be established in the State. 

The Court noted that it was imperative to disseminate certain guidelines on the issue since although effective treatments were available for most rare diseases, only a handful could afford their expenses. Therefore, most of the patients, especially children of tender age, were doomed to die lacking funds to meet the treatment expenses. 

It was also pointed out by the Judge that the lack of facilities in the State for the same was also responsible for this crisis. 

It is to be noted that Spinal Muscular Atrophy (SMA) is an extremely severe and rare genetically inherited degenerative neuromuscular disease and about 100 children in the State suffer from it.

Though there are life-saving drugs including Zolgensma for its treatment, they are prohibitively expensive and no facilities whatsoever have been provided by the Centre or State, especially for those who cannot afford the expenses for the treatment. 

"There cannot be any doubt on the principle that where there is a right, there is a remedy, ubi jus ibi remedium, but the facts of this case, unfortunately, disclose that there is a gap in reality between right and remedy, especially when it comes to the enforcement of rights against State. The attempt of this Court in this matter, therefore, is to bridge the said gap." 

The Court remarked that the credibility of a democratic legal system is intrinsically linked to the enforceability of rights of citizens. It was asserted that the enforcement of socio-economic rights poses a major challenge to the legal system.

"True, in matters where availability of resources has a material bearing and policy regarding priority is involved, it may not be prudent for constitutional courts to give directions. At the same time, when constitutional courts are convinced that fundamental  rights of citizens cannot be enforced without judicial interference, the principle of continuing mandamus which is now an integral part of our constitutional jurisprudence, could certainly be invoked for the purpose of enforcing the fundamental rights of the citizens to bridge the gap between right and remedy."  

Therefore, learning that facilities for treatment of rare diseases would not materialize without judicial interference, the Court found itself constitutionally obliged to issue directions to the State to make available certain facilities:

Directions Issued:

(A) The Centre shall file an affidavit indicating:

• whether the Centres of Excellence (COEs) provided for in the National Policy are working as contemplated
  
• whether amounts sufficient for the treatment of rare diseases, especially for those included in Group-3 of the National Policy could be generated through the digital platform established for crowdfunding
• if not, whether any alternative arrangements have been made for the treatment of such diseases.
• criteria, if any, prescribed for admission of patients suffering from rare diseases belonging to other States in the COEs.
• impediments, if any, in establishing COEs in all the States and if there are no impediments, the steps, if any, to be taken by the State Governments for the said purpose.

(B) The State shall file an affidavit indicating:

• the present stage of development of the Concept Note for raising crowdfunding for treatment of rare diseases
• the steps taken for identification of beneficiaries, and for engaging services of social media groups for encouraging donations for treatment of rare diseases referred to in the affidavit filed by the Principal Secretary to Government, Health and Family Welfare Department dated 1.10.2021.

(C) The State shall indicate in the affidavit, after obtaining the opinion of the experts in the field:

• the particulars of the rare diseases included in the National Policy for which effective treatments are available and the financial burden of which could be borne by the State Government
• the impediments, if any, in making arrangements in one or more Medical Colleges in the State for treatment of rare diseases included in the National Policy
• whether a digital platform could be established exclusively for crowdfunding for treatment of rare diseases, indicating the details of each and every patient undergoing treatment, the summary of disease, the amount required for treatment, the amount collected etc., with provision for separate campaigns dedicated for each patient, with the participation of the representatives of the people.

(D) The State shall forthwith make a provision for receiving the unutilized funds collected at the initiative of the MLAs for treatment of children suffering from SMA and issue a communication to the said MLAs to transfer the unutilized funds to the State.

(E) These funds collected for procurement of drugs for the treatment of children suffering from SMA, shall be earmarked by the State exclusively for such purpose. 

(F) The State shall forthwith identify the children suffering from SMA in the State for whose ailments effective drugs are available, and use the above funds exclusively for procuring drugs for their treatment by prioritising interventions that benefit more number of children with the lesser amount available.

(G)The State shall also make necessary arrangements for the treatment of such children. 

Who filed the petition and why:

The petitioner's son, a toddler, was suffering from SMA. According to him, his son's life could only be saved by administering the drug Zolgensma which costs approximately Rs.18 crores. Since he was unable to secure the drug, he approached the Court arguing that the State was obliged to secure and administer the same to his son.

The Court agreed with the petitioner and observed:

"It is now settled by a long catena of decisions that the right to health and medical care is a facet of Article 21. The State is, therefore, duty-bound to extend medical assistance to everyone for preserving human life."

The Judge further observed that since the life of citizens is a matter of paramount importance in a welfare State, the Government was obliged to provide adequate medical facilities for securing the life of its citizens.

The Court added that no Government can refuse to treat patients with rare diseases due to its financial constraints. In such circumstances,  the State is obliged to make provisions for the same by tapping into resources of civil society and non-Government and charitable organizations.

"...the initiative to tackle situations of this nature has to come from the Government and it cannot shirk its responsibility by contending that it has no resources."

Therefore, the State was permitted to adopt measures to raise funds through donations for the treatment of children suffering from rare diseases. However, it could not do anything substantial in the matter. In fact, only Rs.11.5 lakhs could be generated by the State over three years.

Thereafter, a committee was formed under the Chairmanship of a Member of the State Legislative Assembly to raise funds for the treatment of the petitioner's son which collected approximately Rs.16.5 crores.

Unfortunately, the boy died during the pendency of the writ petition. 

The Court observed that the amounts available with the Committee not claimed back by the donors can only be regarded as made by them intending to part with their money and in that event, the said amount is liable to be treated as bona vacantia.

Noting that the State's inaction to provide any facilities for treatment of rare diseases amounts to flagrant violation of the right to life under Article 21, the Court retained the petition feeling constitutionally obliged to intervene in the matter despite the relief sought for becoming infructuous. 

What is the National Policy for Rare Diseases?

In 2021, the Centre came out with National Policy for Rare Diseases where it categorised rare diseases into three groups.

• Group-1: diseases for which one-time curative treatments are available
• Group-2: diseases requiring long term treatment, the cost of which is relatively low
• Group-3: diseases for which treatments are available, but the cost is very high.

The Centre notified the hospitals referred to in the Policy with facilities for treatment of rare diseases as Centres of Excellence (COE) and made provision for extending financial support up to Rs.20 lakhs for treatment of rare diseases included in Group-1.

In view of the resource constraints and compelling health priorities, it established a digital platform for voluntary crowd-funding to raise funds required for the treatment of the diseases, especially to those under Group-3.  

Why were the Directions issued?

Despite the Centre's initiatives, the economically weaker section of Kerala was not benefitted from them since no Centre of Excellence was established in the State and the nearest COE was at Bangalore. 

Moreover, the State did not have a similar policy for the treatment of rare diseases. It was still in the process of finalising a concept note for raising crowdfunding for this purpose. 

Similarly, the Social Justice Department and the Kerala Social Security Mission are still finalising the norms for the identification of beneficiaries and for engaging the services of social media groups to encourage donations for the treatment of rare diseases.

The Kerala Social Security Mission has established a payment gateway styled as 'We Care' and rolled out an online platform for mobilising contributions and the same can be utilised for mobilising public contributions to support and manage rare diseases. However, all these initiatives were still at its infancy stage. 

The Court noted that if crores of rupees could be collected within a few days by representatives of the people for the treatment of two children suffering from SMA, it could be inferred that State's lackadaisical approach was the cause for its inability to make arrangements for such treatment.

Moreover, crores of rupees are reportedly being collected purportedly for treatment, even through digital platforms provided by private business enterprises.

Considering all these aspects, the Judge found it imperative to issue the aforesaid directions.

The Court will take up the matter after a month during which time the said directions are to be followed. 

Also Read: 

• Regulate Crowdfunding In Private Accounts For Charity : Kerala High Court
• What Will Happen To ₹16.5 Crores Crowdfund?: Kerala High Court Asks State After Child With Rare Disease Dies
• Kerala High Court Calls For Regulative Measures For Transparent, Efficient Crowdfunding Towards Treatment For Rare Diseases 

Case Title: Arif v. State of Kerala & Ors.

Citation: 2022 LiveLaw (Ker) 40

Click Here To Read/Download The Order