OPINION: Give it a shot
PERTH (republished from The Kathmandu Post/ANN) - Local production of medicines should be included in Nepal's national development agenda.
More than three months since the start of the blockade by India, the import of life saving drugs and ingredients required for their production has virtually come to a halt.
The Nepali pharmaceutical industry has suffered a heavy loss due to the shortage of ingredients leading to a reduced production of medicines. Pharmacies are running out of drugs for chronic diseases like hypertension and diabetes and other essential medicines required in hospitals.
According to the Association of Pharmaceutical Producers, Nepal’s pharmaceutical industry fulfils 40 per cent of the domestic requirement of medicines. The rest is met though imports, mainly from India.
As per a 2011 report entitled "Nepal Pharmaceutical Country Profile" published by the Ministry of Health and Population and the World Health Organisation (WHO), 41 pharmaceutical companies are listed by the Department of Drug Administration (DDA).
According to a 2001 estimate by the DDA, the medicine industry’s consumption was roughly $56 million with an annual growth rate of almost 19 per cent, which has significantly grown over the years both in the volume of production and sales.
The production process ranges from semi-automatic to automatic for a variety of products including tablet, capsule, liquid, dry syrup, powder and injectable drugs. The industry, however, is characterised by low investment in research and development, which is only limited to pharmaceutical formulations
Furthermore, a 2005 study entitled "Study of the Nepali pharmaceutical industry" in the context of Nepal’s newly acquired World Trade Organisation (WTO) membership’ states that the country has unfavourable provisions for its own pharmaceutical companies.
Only 5 per cent customs duty is levied on imported drugs while domestic manufacturers have to pay up to 17 per cent in duty and value added tax on imports of packaging and other auxiliary inputs.
The same study mentions that Nepal’s industry lacks competitiveness in the domestic and foreign markets due to higher transport costs, lack of access to international markets and high registration costs in export markets. Also, Nepali people prefer drugs made in India or third countries over drugs produced locally.
Iran has endured US-led sanctions since 1979, however, the supply and distribution of medicines in its market has never been interrupted because of a flourishing domestic pharmaceutical industry.
In contrast to Iran, Nepal has low production capacity and domestically produced medicines are mostly low-cost generic drugs. For drugs required in specialised care like in the treatment of cancer, heart diseases and HIV, the country has to import heavily from India and elsewhere.
Can Nepal ever be self-reliant in medicines? The answer is a big yes. For low-cost generic medicines, Nepal can be self-sufficient in a relatively short period of time.
If the government provides much-needed support in terms of easing policies to create an encouraging environment for production and investment, Nepali pharmaceutical companies can make the country self-sufficient in medicines. However, for specialised medicines including patent drugs, which need a greater technical capacity for production and quality control, we need to take a longer vision.
Technology transfer and collaboration with foreign companies to introduce new technologies in the industry should be promoted as well. However, the current political scenario is a significant impediment to any investment in the pharmaceutical industry. Therefore, the government has to accord priority to local production of drugs, not just for low-cost generics but also for specialised drugs including those required for non-communicable diseases.
Many countries give local pharmaceutical companies ‘compulsory licensing’ for generic production of patent drugs without the consent of the patent owner.
According to the WHO, there are several opportunities under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and flexibilities in the Doha Ministerial Declaration on TRIPS and Public Health in 2001.
The second document stresses the local production of medicines for increasing access to medicines in low- and middle-income countries through technology transfer. However, the implementation of the TRIPS agreement will strengthen patent protection. Nepal’s Health Ministry asserts that even though the country has not fully implemented its commitment to protect intellectual property, it has not been able to exercise the flexibilities it could provide.
The WTO has extended the transition period to protect intellectual property under TRIPS for the least developed countries until 2021 from 2016. So, Nepal can potentially benefit from this extension if the local production of medicines is given priority.
For public health emergencies and calamities, the TRIPS agreement has also specified some fast-track measures that domestic pharmaceutical companies can exploit to start producing. Also, learning from countries like India and China, which have significant built-up capacity in local manufacturing, can help.
India was one of the biggest importers of drugs and intermediaries at the time of its independence in 1947. This trend continued until the 1960s, after which the government introduced policies to increase self-reliance in medicines through local production by launching state-owned pharmaceutical companies.
Within 60 years after independence, India has become one of the world’s leading pharmaceutical producers, fourth in terms of production volume and 13th in terms of domestic consumption.
According to a study published by the US International Trade Commission, India imported medicines and intermediaries worth $985 million, and exported $3.7 billion in 2005, making it the largest supplier of low-cost generic medication in Asia and Africa.
In conclusion, Nepal’s over-dependence on imports should move towards self-reliance by encouraging domestic production of drugs and its formulation through short- and long-term measures.
Also, equal focus should be paid to increasing the quality of production, competitiveness and efficiency. The present increased sense of urgency among the public and polity for self-sufficiency in the production of alternative energy including medicines should be given continuity by improving the policies and investment scenario. This will definitely boost the confidence of the pharmaceutical industry to invest more.
The flexibilities provided by the WTO agreements on intellectual property should be utilised to enhance the production capacity of Nepal’s pharmaceutical industry.
In the context of the extension of Nepal’s transition to the WTO agreement on trade and intellectual property, the concerned stakeholders really need to think about how not to increase prices while ensuring access to essential medicines. The local production of medicines should be put on the national development agenda and made a priority for the future. For that, increased commitment and patronage from the government is necessary.
(The writer is a student of public health at the University of Western Australia.)
An open letter to Gagan Thapa, health minister of Nepal
Perth (republished from SouthAsia.com.au)
A friend of mine died in a road traffic accident (RTA) in Kathmandu last week. He was in his twenties. A promising life was tragically cut short in its prime. Two others whom I knew as my juniors at the Kathmandu-based Institute of Medicine perished in similar bike crashes. Both accidents took place less than two years apart. In addition to these accidents, I know of many senior colleagues who died of non-communicable diseases early in their lives. Such premature deaths of friends and peers cause a deep sorrow in us.
Mr Minister, against this sad backdrop, I have been rather happy since I learned last week about your appointment as the Minister of Health, Government of Nepal. Sir, for quite some time now, you have been a source of tremendous inspiration for youths in Nepal where young population currently comprises a quarter of the country’s demographics. I realise that you and I are currently separated by a great physical distance as well as by certain philosophical and ideological differences, mainly in regard to policies related to market-economics. Add to it the vastly different societal backgrounds we were born into. However, these differences notwithstanding, you are a true inspiration and hero to me. You always have been since you rose to the forefront of Nepalese politics. I see myself in you, and feel that my entire goodwill for my country will rightly be reflected in you in the future.
Hon’ble Minister, I am extremely enthusiastic about your appointment as the new health minister because I sincerely feel that this portfolio was the most suitable match for you. Because you are a part of the younger generation, millions of youths in Nepal and abroad are watching you – mind you, very closely too! Therefore, Sir, it is time for you to decide if you want to live in our dreams for a long to come or, continue bandwagoning hollow political issues with your ageing colleagues, who we all know have led Nepal into episodes after episodes of failure. Their mismanagement has particularly turned the health care industry into the most corrupt sector our nation is currently faced with. To express these boiling ideas and thoughts, I write this letter to you. This letter is not a letter in the traditional sense; it is rather a letter of exchange of wishes between an ordinary citizen who is studying in a foreign land and his health minister back home who invokes a great deal of inspiration in him.
I am aware that you are also a prolific reader who has a deep-rooted interest in the health sector. I know you know how the health industry works and what its current challenges are. When you opened a meat shop few years back, many criticised and ridiculed you. But even then, many youths like myself rightly believed in you thinking it was the right step towards revolutionising Kathmandu valley’s meat industry where adversities in its system make people suffer from lethal diseases such as cholera. It was your first step which was very motivating for the young generation ultimately leading to the establishment of many other improvised and improved meat outlets in the capital city.
Sir, despite the increasing number of RTA-related deaths that appear in newspapers on a regular basis, the more hidden and pervasive in nature are the deaths related to non-communicable diseases (NCDs) like hypertension and diabetes. Obesity is a growing problem in Nepal, even among politicians. You, of all people, should know that many ministers in the current cabinet are obese. I am not speculating; it is very obvious. When I used to watch the Constituent Assembly debates, I noticed that one in every two CA members had bulging bellies. This gave me an idea about how sedentary their life had become by sitting in the CA all day and how stressful it must have been with all the brainstorming they engaged in to draft Nepal’s republican constitution. And, of course the cocktail dinners and periodic invitations from various ministries, embassies and delegation to districts – they might have been truly overjoying. In short, promotion of physical activity and healthy diet is needed among our ministers and parliamentarians themselves – the very role models, let alone the ordinary mass.
Our fellow citizens are not so much different from our past CA members or the current cabinet ministers. According to 2011 STEPS Survey, at least 31% of the population in the cities and 19% in rural areas are obese. Among our civil servants, 33% are overweight or obese – this is according to a study which was published in 2011. Furthermore, 8.4% are diabetic and 33% have hypertension. This is growing rapidly coinciding with the increasing physical inactivity and use of high calorie processed and sugary foods.
Dear Sir, I would like to draw your attention to why there is a drastic change in the disease pattern of the Nepalese population. Less than twenty years ago, communicable diseases were rightly on top of the chart of major causes of mortality in Nepal. Now it is the opposite. NCDs contribute to 60% of disease burden in Nepal, per an estimation based on the outpatient’s visitation in tertiary hospitals in Nepal which was prepared by the World Bank in 2011. The urban centre has a higher ‘sedentarism corporate complex’ – poorly designed urban centres where there is inadequate space for physical activity. Urban green space, parks and availability of free walking space can lead to physically active life and reduce obesity rates in the population. The traditional food habits of our people which traditionally had a high share of dietary carbohydrate, oil and fat has been compromised by unhealthy and imported food culture. Fast food which is nutritionally damaging to health and the source of cheap carbohydrates and fat is detrimental to health. The fast-paced work culture and the inadequate time and space to healthy food options – these factors are the most likely explanation for this growing problem.
Smoking rates have fortunately shown a downward trend and so is alcohol use. But then alcohol consumption among youths has increased. The 2003 Stepwise Approach to Surveillance (STEPS) was the first large-scale study to report risk factors of non-communicable diseases in Nepal. A total of 20.1 % of the respondents were current tobacco smokers and 42.8 % of them were current alcohol consumers. Similarly, 82.3 % had a lower level of physical activity and 99.2 % had less than recommended intake of fruits and vegetables. In the second STEPS survey five years later (2008), the percentage of tobacco smokers decreased by 3.7 % and the percentage of alcohol consumers decreased by 14.3 %. This decreased further by 5.5 % and 11.1 %, respectively in 2013 STEPS survey. Low fruits and vegetable consumption was found among 61.9 % of surveyed participants in 2008. It increased by 37.0 % during 2013 STEPS survey. In addition, the study reported that 7.2 % were overweight/obese and 21.5 % had raised blood pressure in 2008, which was further increased to 21.6 % and 25.7 %, respectively in 2013. The 2013 STEPS survey reported that 4.1 % had impaired fasting glycaemia and 22.7 % had a raised total cholesterol level. The full account of the burgeoning burden of NCDs in Nepal is available elsewhere. Other issues that heavily impact youths should be addressed with a sense of urgency, Sir. Road traffic accidents are the second biggest killer in youth. Therefore, road safety program and vehicle monitoring should start immediately during your tenure.
To come back to the subject of medicines and NCD services, we have unfortunately not been able to provide health services and medicines to rural areas and urban slums. As there is considerable evidence that the rural population also suffers from growing NCDs, these services should by now have been expanded to cover them. As for urban areas, NCD services should reach the poorest of the poor because the slum-dwellers develop them quite easily due to their alcohol and tobacco use.
Recent national policy documents and high level task force on NCDs has prioritized NCDs. However, in the absence of strong commitment from you, it would be impossible to tackle the growing NCD and injuries burden. What does high priority mean if we do not have any structure right up to the primary health care level? Why NCD is our priority when we do not have the basic preventive measures at the community level? What about the highly privatised medical services for the treatment of chronic diseases which poor households can hardly access? Of course, growth in the private sector medical services might have benefited the urban-dwellers but are we really making progress in making these accessible to a person who lives in Upper Dolpa or other far-flung areas? How can we be sure that that our system does not only favor the urban elites but also addresses the health care needs of all, regardless of their ability to pay?
Last but not the least, do we have the necessary resources to implement the programmes on NCDs? And do we have the capacity to carry out research to support the implementation? We need to generate evidence for evidence-based actions in order to attain the desires outcomes in the health sector. Due to lack of proper research, we are currently forced to implement donor-driven programmes and projects. Investment in health care research activities will make it possible for us to develop our own plans and policies that pave way for innovative and cost-effective approaches to addressing current health challenges including NCDs. Will you and others in your ministry support youth-led research and innovations to minimise the burden of NCDs and similar problems the country today faces? Past experiences are not so encouraging. I know of a colleague who has been trying to explore role of our female community health workers (FCHVs) for hypertension management at the community level but he never got any support. He even had meetings with the secretary, minister and member secretary of Nepal Health Research Council but to no avail.
Today’s youths are motivated enough to tackle the country’s problems by bringing in new and innovative ideas. What they need is the support and motivation from leaders like you.
According to the WHO, 20-40% of health expenditure is unproductive. For a country like Nepal, this may simply mean that up to half of the state expenditure is unproductive, given high resource wastage due to low performance of health workers (owing to low motivation, training and supervision), duplication of programmes and corruption. How can we increase the efficiency in the expenditure of tax payers’ money, and justify the support we get from the international donors? Please remember that millions of youths who have supported you in the past are following your actions. So your political reputation and the well-being of our nation would be dependent on whether or not you bail the health sector out of the current chaos. Here, let me remind you that even one degree change in Nepal’s health care would be impossible without sincere efforts. Like me, multitude others have high expectations from you.
It might seem difficult or nearly impossible to try to bring about these drastic changes in the first few months of your tenure. But let me assure you, nothing is impossible if you put your heart and soul into it and give it your best shot, knowledge and passion. Advice from the right people will ease your struggle too.
An architecture of the health system in line with the new National Health Policy and the new constitution of the Republic of Nepal needs to be redrawn. It is worth-mentioning here, Mr Thapa, that the new statute guarantees free health services and the right to health information to all Nepalese citizens.
As you know, three-quarter of health services in Nepal is contracted by patients from the private sector and this has been the reason for a lot of people falling into poverty in recent times. On the positive side, the health insurance system was rolled out to three districts in 2015 and it will hopefully be further expanded to more districts during your tenure. There is excitement in the public due to this, in particular, the health workers (specially following your appointment as the health minister). Now, this is the right time to push for universal health coverage of health services, medicines and health technologies with strong political commitment and community engagement in the insurance programme. The government should seek domestic and international funding for population-based NCD programmes and carry out research activities in the area. It should also come up with stricter taxation policies on tobacco, high-calorie processed-foods and sugary drinks.
There can be many comparative thoughts to indicate that Nepal is under-resourced and is far behind the 21stcentury world regarding access to health service, lack of medical technology and financial capacity. But it is never too late for a new beginning.
Shiva Raj Mishra is a graduate student of Public Health at the University of Western Australia. He writes on public health and has contributed to a number of publications. You can reach him through his twitter account @SRajTweets or email firstname.lastname@example.org.