STRATEGY
Challenges in procurement of “QualityAssured”generics Dr Suresh Saravdekar, Ex-Assistant Director, Ministry of Medical Education and Health, State of Maharashtra and Ex-honorary consultant, Institute of Medical Sciences, Banaras Hindu University (BHU), analyses why procuring quality generic medicines is a challenge even in the 'pharmacy of the world' and suggests some policy changes to rectify this
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aving worked as a medical supplies procurement head for more than three decades at the national and international level in public healthcare services, my responsibility was provision of generic medicines at the lowest price. To obtain generic medicines at the lowest price is not a big task in India which is called the 'Pharmacy of the World of Generic Medicine.'' However, the main difficulty was finding a 'Quality Assured' generic medicine from a market flooded with 'Quality Assumed' generic medicines. Believe me, this was a definitely a Herculean task. But, this quote of Kenneth Arrow, Nobel laureate in Economics kept guiding me: "If buyers know less about goods than the seller does, then the buyer suffers from Information Asymmetry or Handicap.' I found this handicap very prominently in healthcare services, and to remove it, I had to constantly keep myself updated with changes in the national and the international market. This led me to the study of the global pharma market which revealed that besides domestic market forces, global drivers also control the availability, accessibility and affordability of generic medicines within the domestic market in India. Thus, there are direct as well as indirect challenges which need to be faced by providers of generic medicine. Indirect market drivers constitute international policies that also affect the domestic availability and accessibility of generic medicines.
30 EXPRESS PHARMA June 2022
Global challenges Skewed research priorities: Globally, technology has revolutionised all aspects of medical treatment with the adoption of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning (DL). Technology has revolutionised all concepts of medical treatment and health needs. While there is an increased adoption of technology in healthcare, a lot needs to be done in the area of monitoring of essential drugs. As per WHO studies, there are many product gaps and delivery challenges. This is because the priorities in research are not 'need-based' but 'marketbased.' The reality is that there are about 10,000 diseases, world over, including orphan diseases, which are left untreated as medicines are unavailable. Consequently, medicines are available only for 500 diseases which are prevalent mainly in rich and developed countries. Unfortunately, the present scale of technology development does not match the scale of people's need for better access to medicine, particularly in Low-Income Countries (LICs) and low-income groups in Middle-Income Countries (MICs). Hardly any new drug is targeted for diseases prevalent in LICs except for infectious diseases, because they are common in both worlds. For example, COVID infections have shown us that for infections, there are no economic boundaries. However, if we look at the list of new approvals in the pipeline in 2020, the number of
new drugs being invented for cancer are the highest (44), followed by 29 for neurological disorders like Alzheimer's, Parkinson's etc., 18 for diseases associated with endocrine disorders like diabetes. But, there are no new drugs in the pipeline for old infectious diseases like tuberculosis, leprosy, leptospirosis. Artemether is the only new drug invented for drug-resistant malaria and that is by China. Thousands of children are dying each year in Bihar and few other parts of India, but there are still no effective medicines invented for diseases like Kala Azar, sickle cell anemia and Japanese Encephalitis, etc. In India, still we have around 450 orphan diseases without medicines.
IPR blocks Diseases cross all economic borders and spread equally in rich and poor countries. However, the entry of medicines for some diseases is blocked by an international visa called Intellectual Patent Rights (IPR). The price of such patented medicines is governed by Trade- Related Aspects of Intellectual Property Rights
(TRIPS) formulated by the World Trade Organization (WTO) under the influence of "few international companies." The only recent exception is COVID vaccine, as the vaccine was simultaneously developed in India and not exclusively by the MNCs. The only way to break the IPR and make essential and life-saving patented drugs available at low price is if the LICs and MICs have the capacity to manufacture generic versions of patented drugs. However, under current situations, these countries have to operate compulsory and voluntary licensing procedures. But there is a strong resistance to these licenses by the companies and countries owning such patented medicines. Till now, India has approved one compulsory licence to drug maker Natco Pharma on cancer drug Nexavar patented by Bayer. In 2011, Gilead offered voluntary licences for its patented hepatitis drug to local generic manufacturers of India, Malaysia and many more countries. Natco Pharma got a compulsory licence for the sale of generic combination of valsartan and Secubitril, but, in November 2021, Novartis got a Delhi HC stay order on it. The price of this Novartis medicine is Rs 1,100 for 14 tablets, whereas Natco's generic version costs Rs 630 for 14 tablets. Medicine research is, thus, globally dominated by 'few companies' from 'few countries' and done for 'few diseases' prevalent in rich countries. Consider these statistics: ◆ 'WHO Findings - 2021-Access to Medicines and Report
on Disproportionate use of medicines 2020' report reveals that the world over, unequal and disproportionate expenditure/ consumption continues. ◆ 16 per cent of the world's population living in high-income countries accounts for over 80 per cent of global use on medicines. ◆ Remaining 84 per cent of world population accounts for only 20 per cent of pharma use/consumption. ◆ Globally, two billion people worldwide still live on very low incomes without access to medicine or robust health systems. (WHO Findings – 2021-Access to Medicines and Report on Disproportionate use of medicines 2020). It should be, therefore, clear from the above discussion that accessibility, availability and affordability of medicines are not dependent only on domestic factors, but are also challenged by global market drivers.
Domestic challenges Inadequate fund allocation in public healthcare: There is always inadequate public fund allocation for procurement of generic medicines by the state, forcing poor patients to buy essential medicines out of pocket. Secondly, due to unregulated promotion of non-essential generic medicines by the industry, they have to buy non-essential medicines at the cost of essential medicines. Dichotomy in policies: There is a strong dichotomy between industrial policies for pharma and health policies for medicines in India. It is not decided by the same ministry. The National Pharmaceutical Policy is developed by the Ministry of
