Pharmaceutical firms seek incentives to make essential drugs

LAHORE: Medical professionals lament the non-availability of many essential drugs in Pakistan that has turned even some prevalent diseases into ‘orphan diseases’ or rare diseases.
Pakistan Pharmaceutical Manufacturers Association former chairman Amjad Jawa said in developed economies government provides adequate incentives to the pharmaceutical companies to ensure availability of appropriate drugs needed to treat orphan diseases. Generally pharma companies are given government incentives to continue manufacturing drugs for ‘rare diseases’, as otherwise, the drugs lack a sufficient profit margin.
Jawa gave the example of tuberculosis that no longer exists in many developed countries, but the companies are provided funds to produce drugs against this ailment. On the other hand, in Pakistan TB is on the rise, he said. But the drugs to treat TB are not available in sufficient quantity. Tuberculosis is not an orphan disease in Pakistan, but the absence of drugs needed for its treatment have made both this disease and the drugs orphan. He said the regulated prices of drugs required to treat such diseases have not been allowed sufficient inflationary adjustments to retain their commercial viability during the past decade. Such drugs, he added are often low-cost with few or no generic substitutes, thus leaving the patients at the mercy of smuggled, infiltrated products at variable cost and compromised quality.
Medical practitioner Dr Abid Iqbal Khokar said that the germs causing TB have the ability to acquire drug resistance very quickly. He said this is the reason that doctors use combination of drugs for treatment. He said if some drug in the prescription is not available at some point; it becomes harmful because the patient develops resistance to the missing drug rapidly. He said it should be the duty of the government to ensure free availability of anti-TB drugs, as an overwhelming majority of the patients belong to the poorest segment of the society.
Another former PPMA chairman Dr Khalid Javed Chaudhry said the new Drugs Pricing Policy 2015 developed by DRAP acknowledges the existence of ‘Lower Priced Drugs’. The current regulated prices of these unreasonably low (below a sustainable threshold) priced drugs, requires immediate attention / corrective actions, failing which these drugs will cease to be manufactured locally. He regretted that despite this acknowledgement, DRAP has in the new policy ordered to maintain the current prices till July 1, 2016. What should the patients do till then he wondered. He said an alarming development is taking place in the pharmaceutical sector; as local manufacturers are gradually ‘phasing out’ such low priced drugs leading to severe shortages and availability constraints. He said current unrealistically low prices set for such drugs may also force local producers to ‘cut costs’ and compromise on GMP standards. However, he added quality drug manufacturers would prefer to stop manufacturing instead of compromising on good manufacturing practices. Dr Chaudhry said that as an immediate step, the prices of ‘Orphan Drugs’ and/or lower priced drugs should be allowed to increase to the maximum thresholds developed by the Drugs Regulatory Authority and publicly stated in its new Drugs Pricing Policy. “This should be done with immediate effect and without waiting for July 1, 2016,” he appealed. He said it is pertinent to mention that these threshold prices so determined by DRAP are the lowest in the SAARC regional countries.
Any drugs sold below these thresholds, he added are not commercially viable and hence their quality of manufacturing and ingredients can be questionable. Orthopaedic surgeon Dr Rauf Ahmad said that government should act promptly in the supreme interest of the patients. He said in order to identify such lower priced or ‘orphan drugs’ a special committee comprising pharmaceutical experts, DRAP members and medical specialists needs to be convened. He said a financial wizard should also be in the committee that should submit its report within a week by working round the clock. He said these experts would be able to recognise reasonable commercial incentives required by the pharmaceutical industry to invest in the manufacturing and distribution of orphan drugs.
When DRAP itself has acknowledged that such ‘low priced’ drugs cannot be classified under the ‘scheduled category’, any additional price controls on such drugs will be counterproductive, he said.
This will lead to suspension of local production of such medicines in Pakistan, forcing imports at much higher prices, he added.