DRAP working on ‘orphan drug policy’

ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) is set to introduce an ‘orphan drug policy’ which would set up a separate price control regime, ensure availability of drugs needed for patients suffering from rare diseases.

The policy aims to segregate and provide a separate mechanism for ‘orphan drugs’ which help treat rare diseases (usually genetic diseases) and for which only a small number of patients exist. This is why even the Food and Drug Administrations of US (USFDA) and Europe specially designate such drugs and provide incentives to ensure availability.

However, in countries like Pakistan, such drugs get an orphan status since the price control regime renders it too expensive to locally manufacture. This leads to frequent shortages of such drugs and leads to black marketing.
In its Drug Policy 2015, Drap stated that a separate pricing policy would help improve the availability of orphan drugs in the market.

In this regards, the Policy Board of Drap constituted a special committee of medical and pharmaceutical experts, to review such cases and recommend a list of critically needed drugs.

In a recent meeting, the board approved a draft of the policy. Once cleared by the Economic Coordination Committee (ECC) of the Cabinet, the policy would be notified.

Apart from ensuring appropriate price mechanism for these medicines, it would also provide incentives to manufacturers to make such drugs available for needy patients.

“No company can produce such drugs on a commercial basis at the general cost of production, nor is any company likely to invest in research and development (R&D) and clinical trial of such drugs because it does not offer any commercial advantage,” explained Drap CEO Aslam Afghani.

Pakistan is adopting a policy similar to those adopted by USFDA and in Europe through the new rules, he added.

“Orphan drugs for rare diseases, as declared by USFDA and EU authorities, will get out-of-queue status and expedited review, registration process and appropriate reference price to India and Bangladesh, to make these drugs available for needy patients,” he said.

Explaining the need for the special policy, Afghani said that there was an eight per cent cap on hardship cases. Hence, processing orphan drug cases through the hardship category of drug pricing policy were unfeasible.

Realising this situation and to bring a viable solution to address such shortages of critically needed essential drugs, Afghani said that the top drug regulator had decided to devise a new policy.

Source: The Express Tribune