Spells Change for Pharmaceutical Legislation in Drug Prices
The swirls in Pakistan’s politics and related matters seem to have taken a permanent place as the subject of debate globally. The nation itself is the witness of all the appalling cases and scenarios that have taken place over the past months ringing bells to alert the legislators and policy makers about the unpredictability of our legal framework when coming to terms with dealing socio-economic crisis. In the past, the Healthcare sector of Pakistan has managed to just edgingly spare itself from the various hurdles thrown at it every now and then, however, the situation at present does not paint a favorable picture. As it turns out that the Federal Cabinet in its recent meeting rejected to approve price increase of around 35 life-saving essential drugs, which is expected to cause backlash to the authorities and the public at large when these life-saving drugs go short in the market due to commercial non-viability for the manufacturers.
Federal Cabinet refuses to provide relief to pharmaceutical industry for life saving drugs A piece of news that has recently taken the Pharmaceutical Industry aback is the refusal of an increase in the prices of 35 essential life-saving drugs including anti-TB, anti-cancer, pain killers, anti-epileptics, medicines for Parkinson’s disease, medicines for cardiovascular diseases, and antibiotics, which were justifiably demanded by the various pharmaceutical manufacturers on grounds of hardship. This may superficially appear to favour the common man, but the setbacks that are unforeseeable right now may evolve into a major health crisis later on. As abiding by this decision of the Cabinet, the concerned pharmaceutical manufacturers might not be left with any option other than suspending the production and marketing of these medicines due to the cost ineffectiveness of the drugs, resulting from the escalation in prices of raw materials. This would inadvertently lead to market shortage of accessible and affordable life-saving drugs, and automatically compel the public to opt for costlier medication to mitigate the disease. Despite being provision of Hardship Price Increase in the Drugs Pricing Policy 2018, the justified price increase applications were refused by the Federal Cabinet The Federal Cabinet approved the Drugs Pricing Policy 2018 on 12th June 2018, which provided a comprehensive mechanism for the increase in drug prices on grounds of justified hardship cases applied by the drug manufacturers. Following the relevant procedure prescribed in the Policy, the various manufacturers submitted their respective hardship cases along with documentary evidence, elaborating on the difficulty to manufacture these life-saving drugs, owing to global price hike in API prices, the massive dollar-rupee parity and ever-increasing inflation, and the high cost of production and utilities. The basis for the rejection of the price increase summary appears to be incomprehensible to these applicants when the application was processed by the Division of Costing and Pricing, DRAP after an extensive evaluation and verification of the documents provided by the aggrieved manufacturers. Who has the power to fix Maximum Retail Prices of Drugs and is it really justified? The Drug Act 1976 regulates the import, export, manufacture, storage, distribution, and sale of drugs. Section 12 of the Act explicitly states that the power to fix maximum price of the drugs resides with the Federal Government. All manufacturers are bound to sell their drugs at or below the fixed maximum retail prices. Any violation of this regulation is an offence and liable to punishment both by fine and imprisonment. However, after the promulgation of DRAP Act 2012, the Drug Regulatory Authority of Pakistan was duly authorized to regulate the prices of the drugs through a comprehensive pricing mechanism. Though the Division of Costing & Pricing, DRAP is the authorized body to inquire about the documentary evidence to review, calculate and recommend drugs prices, new or hardship, the final approval is to be given by the Federal Government. It is pertinent to know the DRAP is the relevant authority dealing with necessary license approvals for drug manufacture, import, export, development, distribution, and sale in Pakistan, such that it is effectively competent body to recommend drug prices keeping in view API costs, manufacturing expenses, and related operational costs. In such regard, it is often debated that the authority shall be given the power in entirety to fix and approve the drug prices, rather than conferring this crucial function to the Federal Government. This is to the effect that DRAP has been formulated by the Federal Government for the very purpose of regulation of drug manufacturing, distribution, and sale, and that the whole procedure for drug price approval, new or hardship, takes months as the cases have to wait for the Cabinet Meeting to include these matters in their agenda. Eventually, it is the health sector and the common man that bears the repercussions of the deficient functioning of the system. The impact of Cabinet decision on Public Health After waiting for almost three years, the Cabinet gave the decision of the hardship cases at last, only to refuse any relief that may have been allowed to the drug manufacturers to ensure consistent availability of life-saving drugs in the market. This decision will have a major influence on the progression of the country’s pharmaceutical department. There is a worldwide rise in the encouragement of innovation to solve unmet medical needs which will induce a swift spike in pharmaceutical advancement. On the other hand, in an underdeveloped country like Pakistan, the suspension of already sold and widely used medicines will regress the growth of the pharmaceutical sector and act as a spark for igniting the medicinal crisis. Not to mention, the disparity it may bring among the public when they will have to settle for medicines that are beyond their budget. Lastly, the fact to ponder over is that this rejection is against the law and it disregards the benefit that was given to the aggrieved parties many years ago. How the vicious spell of high drug cost – low drug availability may be broken Paracetamol, one of the commonly used drugs, which already underwent a shortage in the market due to the price increase of API is at a chance of vanishing completely due to this decision. However, given the fact that it is an essential drug, the periodic increase other than annual CPI shall be allotted keeping in view the rate of inflation worldwide in order to counter the effects of increasing API cost. And the same should be done for all the essential and other life-saving drugs. The other way forward to counterbalance this situation is the provision of the authority of making policy changes in the law to DRAP and policy Board instead of the Federal Government. As DRAP gets the first-hand opportunity to listen to the aggrieved parties and authenticate their cases. The impact of Cabinet decision on Public Health After waiting for almost three years, the Cabinet gave the decision of the hardship cases at last, only to refuse any relief that may have been allowed to the drug manufacturers to ensure consistent availability of life-saving drugs in the market. This decision will have a major influence on the progression of the country’s pharmaceutical department. There is a worldwide rise in the encouragement of innovation to solve unmet medical needs which will induce a swift spike in pharmaceutical advancement. On the other hand, in an underdeveloped country like Pakistan, the suspension of already sold and widely used medicines will regress the growth of the pharmaceutical sector and act as a spark for igniting the medicinal crisis. Not to mention, the disparity it may bring among the public when they will have to settle for medicines that are beyond their budget. Lastly, the fact to ponder over is that this rejection is against the law and it disregards the benefit that was given to the aggrieved parties many years ago. How the vicious spell of high drug cost – low drug availability may be broken Paracetamol, one of the commonly used drugs, which already underwent a shortage in the market due to the price increase of API is at a chance of vanishing completely due to this decision. However, given the fact that it is an essential drug, the periodic increase other than annual CPI shall be allotted keeping in view the rate of inflation worldwide in order to counter the effects of increasing API cost. And the same should be done for all the essential and other life-saving drugs. The other way forward to counterbalance this situation is the provision of the authority of making policy changes in the law to DRAP and policy Board instead of the Federal Government. As DRAP gets the first-hand opportunity to listen to the aggrieved parties and authenticate their cases.
