By Dr.Panduka Karunanayake
The proposed National Medicinal Drug Policy (NMDP) is remaking news. This follows the Health Minister’s recent revelation at a ceremony commemorating the late Professor Senaka Bibile that the government intends to implement it soon.
Professor Bibile was the intellectual giant behind the landmark pharmaceutical sector reforms of the sixties and seventies ably supported by political stalwarts Bernard Soyza and Dr. S.A. Wickremasinghe. The latter two were MPs in the 1970-77 government - all three were leftists. However, following the post-1977 trade liberalisation, the reforms lost much of their punch.
Socialists and those who generally value the pro-poor results of Professor Bibile’s reforms have continued to agitate for a return to his policies. The clamour for the new NMDP has been one of their most vociferous demands. However, it has languished since 2005, allegedly due to pressure from pro-liberalisation groups.
Therefore, it would be interesting to see whether the Minister’s proclamation turns any truer than similar ones made by his predecessor.
The proposed National Medicinal Drug Policy (NMDP) is remaking news. This follows the Health Minister’s recent revelation at a ceremony commemorating the late Professor Senaka Bibile that the government intends to implement it soon.
Professor Bibile was the intellectual giant behind the landmark pharmaceutical sector reforms of the sixties and seventies ably supported by political stalwarts Bernard Soyza and Dr. S.A. Wickremasinghe. The latter two were MPs in the 1970-77 government - all three were leftists. However, following the post-1977 trade liberalisation, the reforms lost much of their punch.
Socialists and those who generally value the pro-poor results of Professor Bibile’s reforms have continued to agitate for a return to his policies. The clamour for the new NMDP has been one of their most vociferous demands. However, it has languished since 2005, allegedly due to pressure from pro-liberalisation groups.
Therefore, it would be interesting to see whether the Minister’s proclamation turns any truer than similar ones made by his predecessor.
Balance
From the first place, why do we need a policy?
Providing efficacious medicines to those who need them is an inescapable responsibility of all societies, given today’s egalitarian values. It involves the integration of several layers of societal activity: science (discovery, evaluation), technology (innovation, manufacture), economics (wholesale procurement, distribution, marketing), professional practice (medicine, pharmacy) and ethnographic aspects (consumption, health-seeking behaviour).
The need for a policy lies in the necessity to coordinate and provide for all of them and to achieve the right balance between them.
However, such policies are invariably dominated by the macroeconomics issues. The proposed NMDP is no exception. Although this may seem invariable, it is not inevitable.
Historical roots
To understand the NMDP, we must see its historical roots.
Professor Bibile, Dr. Wickremasinghe and their contemporaries had their intellectual growth in the early twentieth century under two shadows: on the one hand Imperialism, the two World Wars and the Great Depression, and on the other hand, the spectacular industrialization of the Soviet Union. Naturally then, socialist or communist models impressed the educated colonial youth.
The western pharmacopoeia yet contained only a few efficacious medicines, such as digoxin, quinine and ergometrine.
With decolonisation, the newly independent states inherited relatively good economies from the colonial days, and faced increasing democratisation and egalitarianism at home. Thus, universal free provision of medicines was a rather natural choice for them.
However, the situation deteriorated rapidly after Independence. On the one hand were faltering economies and dwindling forex reserves. On the other hand were exploding populations and the acceleration in discovery of new efficacious medicines in the fifties threatened to increase the medicines bill enormously.
Pharmaceutical manufacturing was still a high-tech affair, undertaken mostly by the industrialised West, especially multinational corporations (MNCs). After the patent life of an innovator brand of a medicine expired, usually a few such MNCs or western manufacturers would compete with it by marketing competing brands (so-called generics or ‘branded-generics’), so that generics were still in good quality.
The Bibile reforms
Ceylon too had to face these challenges. In the sixties, Professor Bibile spearheaded our response by introducing the essential drugs list centralising and bulk purchasing generic medicines and rationalising prescribing.
These initial steps successfully reduced the country’s medicines bill without any shortages or significant quality failures at a time when our economy was in the doldrums and forex reserves were at crisis point. Emboldened by this success and backed by political support, he then embarked on the more revolutionary reforms of the seventies (see Box 1).
Competing interests, perhaps best epitomised by the US Pharmaceuticals Manufacturers’ Association, opposed the implementation of these proposals. Eventually, the government decided to halt full implementation in 1976 in the face of the economic crisis, whereupon Professor Bibile resigned as chairman of SPC.
From the first place, why do we need a policy?
Providing efficacious medicines to those who need them is an inescapable responsibility of all societies, given today’s egalitarian values. It involves the integration of several layers of societal activity: science (discovery, evaluation), technology (innovation, manufacture), economics (wholesale procurement, distribution, marketing), professional practice (medicine, pharmacy) and ethnographic aspects (consumption, health-seeking behaviour).
The need for a policy lies in the necessity to coordinate and provide for all of them and to achieve the right balance between them.
However, such policies are invariably dominated by the macroeconomics issues. The proposed NMDP is no exception. Although this may seem invariable, it is not inevitable.
Historical roots
To understand the NMDP, we must see its historical roots.
Professor Bibile, Dr. Wickremasinghe and their contemporaries had their intellectual growth in the early twentieth century under two shadows: on the one hand Imperialism, the two World Wars and the Great Depression, and on the other hand, the spectacular industrialization of the Soviet Union. Naturally then, socialist or communist models impressed the educated colonial youth.
The western pharmacopoeia yet contained only a few efficacious medicines, such as digoxin, quinine and ergometrine.
With decolonisation, the newly independent states inherited relatively good economies from the colonial days, and faced increasing democratisation and egalitarianism at home. Thus, universal free provision of medicines was a rather natural choice for them.
However, the situation deteriorated rapidly after Independence. On the one hand were faltering economies and dwindling forex reserves. On the other hand were exploding populations and the acceleration in discovery of new efficacious medicines in the fifties threatened to increase the medicines bill enormously.
Pharmaceutical manufacturing was still a high-tech affair, undertaken mostly by the industrialised West, especially multinational corporations (MNCs). After the patent life of an innovator brand of a medicine expired, usually a few such MNCs or western manufacturers would compete with it by marketing competing brands (so-called generics or ‘branded-generics’), so that generics were still in good quality.
The Bibile reforms
Ceylon too had to face these challenges. In the sixties, Professor Bibile spearheaded our response by introducing the essential drugs list centralising and bulk purchasing generic medicines and rationalising prescribing.
These initial steps successfully reduced the country’s medicines bill without any shortages or significant quality failures at a time when our economy was in the doldrums and forex reserves were at crisis point. Emboldened by this success and backed by political support, he then embarked on the more revolutionary reforms of the seventies (see Box 1).
Competing interests, perhaps best epitomised by the US Pharmaceuticals Manufacturers’ Association, opposed the implementation of these proposals. Eventually, the government decided to halt full implementation in 1976 in the face of the economic crisis, whereupon Professor Bibile resigned as chairman of SPC.
Globalisation
Thereafter, the post-1977 government liberalised the economy. However, it is noteworthy that Dr. Gladys Jayewardene, who became SPC’s chairperson after 1977, continued some of Professor Bibile’s strategies and inaugurated the State Pharmaceuticals Manufacturing Corporation before she was assassinated in the late eighties.
This period was characterised by the gradual collapse of the Soviet bloc and communism, the East Asian miracle, the shrinkage of the state and the rise of liberalisation and globalisation. The supremacy of the state underwent erosion, and private entrepreneurship became drivers of economies everywhere. The medicines bill expanded beyond all prediction; even industrialised countries were stretched by it.
The most important change in the pharmaceutical industry, however, was the diffusion of manufacturing technology: Argentina, Bangladesh, Brazil, China, Cyprus, Egypt, India, Indonesia, Malaysia etc joined the global industry (see Box 2).
This meant that prices were lower, but also that one could no longer take quality of the generics for granted. Today, the term ‘generics’ carries different connotations to what it meant to Professor Bibile: while in his time quality failures were insignificant, to claim the same for today would be hilarious.
The western MNCs responded to this trend through mergers, modifying intellectual property rights, and by shifting medical practice into technologies that could not be copied so easily (such as personalised medicine, biotherapy etc) – which meant that the drugs bill was set to rise even further.
In hindsight
In hindsight, the reforms were able to save enormous amounts of forex, and thereby prevent immense drug shortages and inequities. It is true that we do have shortages and inequities today, but the situation would probably have been much worse earlier, if not for the reforms.
At the same time, there are also shortcomings. Poor quality has become a big issue, and we failed to promote manufacturing. These have arisen out of the reformists’ failure to correctly judge two processes: the evolution of the MNC (from a purely western institution to a truly global one, including MNCs from Third World countries) and the diffusion of technology.
Both processes are the result of globalisation. While globalsation manifested earnestly in the nineties, its nascent roots – including the potential in pharmaceutical manufacturing – were not unknown even in the seventies (see Box 3). In fact, this prompted India to amend her patent laws then and set her pharmaceutical industry sailing.
Rethinking
On this background, we must carefully rethink our strategies. We may still hold on to the same objective – namely, providing safe, efficacious and quality medicines to people who need them – but obviously, we cannot hold on to the same strategies.
Fortunately, we have several significant strengths. We have developed a reservoir of expert and experienced technocrats in some fields (especially medical, pharmaceutical and regulatory); an extensive know-how for registration, evaluation, development of technical specifications etc; and an energetic, resilient private sector. Above all, we have the SPC, which is like a genie in a lamp waiting to be rubbed the correct way.
We also need some new strength. We need expertise in manufacturing, economics and international trade law; social science research on policy process; and anthropological or ethnographic research on health-related behavior and its modification. Above all, we need to rub the magic lamp: the state must pay the SPC its dues and enable it to realise its full potential, before it is too late.
Frozen
Does the proposed NMDP address all these issues (Box 4)? Or is it a collection of outdated, politically alluring platitudes?
The conflict between two opposed forces – pro-poor vs. pro-liberalisation – has taken its toll. Today, the NMDP ‘policy content’ reflects the politically fashionable, pro-poor thinking of the seventies, frozen in time. The pro-liberalisation camp has simply let it lie there and shifted the battleground to ‘policy process.’ As a result, the reality outside neither reflects its policy content nor is amenable to its ideology.
Professor Bibile did his bid for the nation – by thinking anew and fearlessly changing old ways. We have always commemorated him, of course, nevertheless, have we honoured him and followed him?
The writer acknowledges the writings of Senaka Bibile, Eric Hobsbawm, Sanjaya Lall, Sjaark van der Geest, Gill Walt and Krisantha Weerasuriya, and supervision by Dr. Chandani Liyanage. He teaches medicine at the University of Colombo. The views expressed are his own.
http://www.nation.lk/2011/11/13/newsfe8.htm
http://www.nation.lk/2011/11/13/newsfe8.htm
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