New Delhi: After the government’s embarrassing back-track in the Delhi high court last December – where it said it cannot support patients with rare diseases – pressure from patient groups is growing.
The Wire reported this month that the health ministry wanted another nine months to develop a new rare disease policy after withdrawing the one released in 2017. The Delhi HC ordered the ministry to come up with this policy in 2016.
According to the government’s 2017 policy, a rare disease is a health condition with low prevalence, affecting a small number of people when compared to other diseases prevalent in the general population. About 6,000 to 8,000 rare diseases exist, but 350 of them occur most often. Most rare diseases are also genetic and disproportionately affect children.
Ashok Agarwal, a lawyer representing a number of patients with rare diseases, has written to the union health secretary on Wednesday. He asked the ministry to release money to patients who have applied for financial assistance.
Also Read: After U-Turn on Rare Disease Policy, Health Ministry Assures New One in 9 Months
A number of rare disease patients applied for funding from the government’s promised corpus fund of Rs 100 crore, which The Wire reported in 2017. None of them received this money, over a disagreement between the Centre and states.
In Agarwal’s letter, he urges the government to act irrespective of this confusion. He wanted the government to perform a medical review of all applications by an expert committee within a month. He also says the ministry should keep its rare disease cell functioning during the nine months it will take to unveil the new policy. The cell should keep receiving requests from patients and conduct medical reviews, Agarwal says.
The lawyer says that the government should arrange interim treatment after this medical review to patients who qualify. This should be irrespective of whether the patients are below or above the poverty line.
Two of his clients are also children who are affected by the rare disease Mucopolysaccharidosis type I (MPS 1). It is their case that has become the trigger for the national rare disease policy. In the last Delhi HC order, the judge specifically mentioned the two children receiving treatment for MPS 1, saying they should not face any difficulties.
Agarwal’s letter reminds the government of their responsibility here as well.
Capping the prices of drugs
On Friday, other patient groups and activists have also issued a statement on the department of pharmaceutical’s proposal to not have any price caps on drugs for rare diseases. This was announced via a gazette notification in January, the Times of India reported.
Late last year, the health ministry wrote to the department of pharmaceuticals, asking them to consider controlling prices of these drugs either via price caps or through compulsory licenses. But the department soon put out this notification, announcing the exact opposite.
After a meeting in the Prime Minister’s Office following criticism, the government has reportedly decided to cap just the trade margins of these rare disease drugs.
Also Read: Delhi High Court Urges State Governments to Step up on Handling Rare Diseases
The patient groups say the move to cap trade margins is insufficient and is a knee jerk reaction to deflect criticism of the decision to not have any caps at all.
For example, the statement talks about the drug Spinraza, which is used to treat spinal muscular atrophy. It is priced about Rs 5 crore per year and is not available in India.
As a compromise, the government then drew up a list of about 70 drugs for rare diseases and cancer, and said it would look into the prices of these drugs. The press statement says this list “leaves out several critical medicines. The mechanism being suggested to bring down their prices is faulty and inadequate.”
“The whole exercise is a poor attempt to make up for a bad policy decision,” says the statement, referring to the department of pharmaceutical’s January notification.