The Pharmaceutical Sector in Madagascar - Coursework Example

?The Pharmaceutical Sector in Madagascar The pharmaceutical sector in Madagascar appears to be a lucrative one in theory for many companies. Due to its unique geography and history, Madagascar is home to a wide variety of fauna and flora that not present anywhere else in the world. It is home to large rainforests which have numerous undocumented species living within them. This enormous array of plants has meant that pharmaceutical companies are eager to research certain plants to see if there are any potential therapeutic benefits. These can then be developed into drugs in the western world and marketed in ventures where a pharmaceutical company can make millions if not billions of dollars. To do this, they have encouraged conservation efforts of the rainforests as well as speedy cataloguing of all the different species that are largely unknown to date. Thorough all of this, it must be taken into consideration that while Madagascar does not have the financial resources to develop the drugs themselves, these pharmaceutical companies are working in a sovereign country where the biological flora present is, in fact, a property of that country. This must be delicately balanced with attaining the materials needed for research as well as keeping within the legal framework of the country. For a start, this paper will first take a brief look at the country of Madagascar. It will examine some general facts, the political and economic situation in the country and the tropical rainforests. The interest of pharmaceutical companies lies primarily in these forests and the importance of conservation of these forests will be detailed. Some examples of plants that have been successfully developed into drugs will be made mention of as well as the legal aspects of exporting biodiversity such as this to other countries. In addition, the financial aspects that are considered why a pharmaceutical company will be detailed followed by a discussion of whether it is worth investing in the pharmaceutical industry of Madagascar by companies based in the western world. Madagascar is an island in the Indian Ocean that is located about 400km away from the coast of Mozambique. It is the world’s fourth largest island. It covers an area of 587,041 sq km (226,658 sq miles) (BBC News) and has a population of 20.1 million (UN, 2010 from BBC News). The inhabitants of Madagascar, the Malagasy are descendants of the both Africans and Indonesians who moved to this island over 2000 years ago (BBC News). Madagascar used to be a French colony and only gained independence 1960 (BBC News). Due to this colonialism, Madagascar has strong ties both culturally and economically both to France and other West-African countries where French is spoken (BBC News). The two main official languages in the country are Malagasy and French though English was recently introduced as an official language too (BBC News). Due to its positioning, Madagascar is prone to being affected severely by massive flooding and torrential rains, the latest being in 2000 and later in 2004 (BBC News). Natural disasters have not been the only challenge the people of Madagascar have faced. The country has been in political turmoil for a number of years. Andry Rajoelina, along with the army’s support overthrew the president at the time Marc Ravalomanana. Rajoelina Rajoelina’s government has not been recognized internationally and no agreement has been reached with other political parties in the country. Due to this stalemate, Madagascar’s economy has suffered with private investment slowing down and international donors suspending support (BBC News). It has been approximated that up to 70% of people in Madagascar survive on less and a dollar a day (World Bank from BBC News) and the Gross National Income (GNI) per capita was US $420 (World Bank, 2009 from BBC News). Poverty is widespread and there has been much competition for agricultural land (BBC News), which is where the next aspect of this paper leads us to. The forests are home to much of the products that foreign pharmaceutical companies are interested in. Madagascar has been an island for over a 100 million years (Lemoine,1906; Lamberton, 1948 from Rasoanaivo,1990) and this has resulted in much of the species on the island have evolved in isolation when compared with the rest of the world (Millot, 1952 from Rasoanaivo,1990). It has been approximated that about 13 000 species of plants are found in Madagascar (Perrier de la Bathie, 1921; Capuron, 1957; Humbert, 1959; Boiteau, 1975-1979 from Rasoanaivo,1990). Of this large number, a massive 80% is seen to be endemic to the island (Humbert and Perrier de la Bathie, , 1948-1960 from Rasoanaivo,1990). Several medicinal plants that are present only in Madagascar and have been thoroughly researched by researchers from the West and many discovered have been made in the form of much-needed medicines (Markets for Selected Medicinal Plants and Their Derivatives, 1974; Farnsworth et al, 1985 from Rasoanaivo,1990). Around 125000 or 50% of the known flowering species on Earth have been seen to be present in tropical forests such as the ones in Madagascar (World Conservation Monitoring Centre, 1992 from Mendelsohn and Balick, 1995). There is much importance attached to researching the flora found in the tropical forests of Madagascar and this is due to two main reasons. The first is that several of the plants are under threat due to the method of preparing the land for farming also called ‘tavy’). This method includes slashing and burning and this promotes deforestation (Humbert, 1927 from Rasoanaivo,1990). In addition there are other environmental pressures from factors like pollution and all stemming as a result of poverty (Cao and Kingston, 2009). The second reason for researching the flora is that much of species present have yet to be documented due to the vast number of species present (Rasoanaivo,1990). Estimates indicate that about 99% of plants is still unknown (Rasoanaivo,1990). This is where the two above mentioned reasons of researching the flora tie in together. If, for example a plant with interesting bioactivity that might have future uses was discovered, it would be extremely unfortunate if researchers went back only to find no trace of it due to the habitat being destroyed due to deforestation (Rasoanaivo,1990). There have been three medicinal plants found to be significant in the rainforests of Madagascar: Ilex mitis, Eugenia jambolana and Aloe vahombe (Rasoanaivo,1990). Ilex mitis was seen to have wound-healing properties (Rasoanaivo, 1984 from Rasoanaivo,1990) though other studies have reported conflicting results on its other properties (Rasoanaivo,1990). Eugenia jambolana is being investigated as a potential anti-diabetic medicine (Rasoanaivo,1990) and Aloe vahombe seems to display immune-stimulant activity and being investigated for its potential use in cancer (Ralamboranto, 1988 from Rasoanaivo,1990). Three main areas of research have focused on finding `plants that might help in the battle of cancer and AIDS (Scientists seek cancer cures in rain forests, 1987; Booth, 1987 from Rasoanaivo,1990). The theory is that since the plants found in tropical rainforests have coexisted with animals, insects, parasites and fungi for a vast amount of time. The plants might have possibly developed methods for survival which may be effective against things like cancer (Rasoanaivo,1990). It is undoubtedly the case that in recent years pharmaceutical companies have been opting for newer methods of producing drugs through genomics or combinatorial chemistry but the fact that drugs developed from natural products still makes up a bulk of current drugs on the market is undeniable (Cao and Kingston, 2009). Statistics show that about a third of the approved drugs in the United States on the market (Cao and Kingston, 2009). In fact, 39% of the drugs that were deemed suitable for use between the years 1983 and 1994 were produced using natural products. These included drugs for 33 different diseases (Cragg et al, 1997 from Cao and Kingston, 2009). Taking a broader view, there were 1184 drugs approved for use by the appropriate regulatory bodies between the beginning of 1981 and June 2006 and 28% of this number were either natural products or derivatives of natural products. A further 4% were produced using the skeleton provided bu natural compounds (Newman and Cragg, 2007 from Cao and Kingston, 2009) as has been the technique employed by producers of drugs for thousands of years (Cragg and Newman, 2001 from Cao and Kingston, 2009). The World Health Organisation (WHO) has approximated that a staggering 80% of the world’s population use traditional medicines as their primary mode of healthcare. In addition, the remaining 20% of the population who live in predominantly developed countries rely on drugs that are synthesised mainly by the use of natural compounds (Cragg and Newman, 2005a from Cao and Kingston, 2009). There were forty seven major pharmaceutical drugs that were discovered from plants in tropical forests as of 1989 (Soejarto and Farnsworth, 1989 from Mendelsohn and Balick, 1995). The continued exploration by pharmaceutical companies in countries like Madagascar needs to go hand in hand with conservation and development economically in the target countries. It is, with this goal in mind that the International Cooperative Biodiversity Group (ICBG) was set up (Cao and Kingston, 2009). This organisation ensures that potential pharmaceutical products are researched while maintaining international set standards for protecting the rights of the inhabitants of the countries. It is undoubtedly the case that pharmaceutical companies are primarily interested in the financial gains associated with the discovery and production of a new drug. While this is the case, social benefits exist as well. Values of between $420 billion (Pearce and Puroshothaman, 1993 from Mendelsohn and Balick, 1995) and $900 billion (Gentry, 1993 from Mendelsohn and Balick, 1995) have been estimated as the value of a new drug. In most species of plant, five different parts of the plant can be separated. This includes the roots, stems, leaves, flowers and fruit though in some plants, not all of these are present. Each of these parts can be treated to extract the chemicals compounds present. It has been averaged that there are two extraction methods and on average three parts to each species. This leads to a total of six extracts per species. This leads to a calculation of there being approximately 750 000 extracts that could be extracted from plants in the world’s tropical forests (Mendelsohn and Balick, 1995) like in Madagascar. This number does not eve include the plants that have not yet been documented and so in reality the number is much higher. There are about 500 screening tests to be applied that are usually run on each sample extracted from a plant to see if any new drug manufacture is possible from therapeutic functions (Mendelsohn and Balick, 1995). On average, about one in five hundred thousand and one in one million tests usually provide one effective drug that can be manufactured commercially (Reid 1993; G. Cragg pets.comm.; and A.D. Kinghorn pets.comm from Mendelsohn and Balick, 1995). The research behind producing a drug and the development of it is an expensive venture for a pharmaceutical company and the costs increased from $65million in the 1970’s to $155 in the 1980’s (Hansen 1979; DiMasi, Bryant, and Lasagna 1991from Mendelsohn and Balick, 1995). This figure is likely to be even higher now. Much of these costs stem from drugs which fail the pre-clinical and clinical trials. Making improvements to these drugs to enable them to pass takes time and money. The development of a single drug from its initial start to receiving approval from the Food and Drug Administration in the United States take between 9 to 12 years (Mendelsohn and Balick, 1995). On average, a massive sum of $155 million is spent during this time (Mendelsohn and Balick, 1995). Educated guesses have been hypothesized as to the worth of a newly developed drug to a pharmaceutical company and it has been averaged to be worth $94 million to a private company. In addition, it is usually worth about $ 449 million to the wider public as a whole. As only about one eighth of the possible pharmaceuticals in the world’s forests have been developed into drugs, it seems safe to say there are millions if not billions of dollars waiting to be tapped into in these forests (Mendelsohn and Balick, 1995). If considering all the derivatives that can come from one drug, one drug can be said to be worth between three and four billion dollars to the pharmaceutical company. To society as a whole, this increases the value to an astounding $147 billion (Mendelsohn and Balick, 1995). In addition, it has been illustrated the revenue from a certain drug follows a hill-like slope. The peak is reached about 10 years after approval is obtained from the FDA and goes down after this. The highest value of the drug is at the peak and this value has been increasing steadily from 50 million in the 1970’s to 150 million for in the 1980’s. The time period after the peak generally corresponds to ten years when the company loses its patent on the drug. Generic equivalents tend to be manufactured by other companies from this point onwards and the value goes down (Grabowski and Vernon, 1990 from Mendelsohn and Balick, 1995). Due to the extremely high costs incurred from development of a drug that are mentioned in the preceding paragraphs, it is not usually possible for developing countries like Madagascar to research and develop drugs on their own. There is substantial research done within Madagascar into the therapeutic properties of some plants (Rasoanaivo,1990) but it is is unreasonable to expect any major drug development to occur in the country itself. To put this into perspective, it was mentioned that the development of a drug is over a hundred million. The Gross National Product (GNP) of Madagascar in 2005 was 5.37 billion while in the same year the GNP of the United States was 12 970 billion (Students of the World, 2003). It is however, reasonable to say that partnerships formed between developing countries such as Madagascar and large pharmaceutical companies capable of funding the development of a drug will benefit both parties (Mendelsohn and Balick, 1995). It will enable for the exchange of knowledge, resources and capital (Mendelsohn and Balick, 1995). It must be noted that some researchers have been critical of the expectation that the native tribes of countries such as Madagascar will want to share expertise as to the plants they use for various ailments. The tribes of Madagascar have been expected to offer up information in the name of being beneficial to use to people in foreign countries. This exchange of intellectual property takes place almost at no advantage to the natives. They may be often given some financial incentives but these are nothing in comparison with the money a pharmaceutical company can make from the research and development of a drug (Harper, 2005). Harper, 2005 has gone as far to suggest that the human rights of the people of the tribes of Madagascar are being neglected and it might be worthwhile the people in the developed world asking themselves how the drugs developed could be made available to the native people. It is a sad fact that much of the finished product will never reach this population (Harper, 2005) as they are outside of the 20% of the people who live in developed nations (Cragg and Newman, 2005a from Cao and Kingston, 2009). There have been other critics of this use of plants from developing countries for development in market in the west. The term ‘biopiracy’ has even been coined to describe the theft of information and flora for drug use (Stenton, 2003). An example of this that has been cited is the one of the plant ‘Rosy Periwinkle’ which is indigenous to Madagascar. The pharmaceutical company Eli Lily has used it to manufacture drugs and makes about $100 million a year off sales of this. The country of Madagascar, however, makes no revenue (Stenton, 2003). The Rosy Periwinkle had been used by native tribes in the treatment of diabetes (Harper, 2005). Eli Lily (Stenton, 2003) discovered that it could also be used to treat leukemia in children and this is where a bulk of its profits come from (Harper, 2005). A report that was commissioned by Christian aid highlights how sever the problem of biopiracy actually is. It was found that developing countries are being cheated out of $4.5 billion every year due to biopiracy (Patents on life: 4. Fair Trade?’ from Stenton, 2003). The United Nations Development Programme (UNDP) puts the figure even higher at $5.4 billion (Conserving Indigenous Knowledge: Integrating two systems of innovation from Stenton, 2003). To combat this, there was a Convention on Biological Diversity (CBD) in 1992. The main goal of this convention was to promote ‘fair and equitable benefit sharing’ (Article 1 from Stenton, 2003).it also took into account that conservation of certain ecosystems must be in harmony with development (Stenton, 2003) and the sovereignty of a country and its ownership of the biological resources present on it are recognized (Article 1 from Stenton, 2003). There were over 168 countries who agreed to abide by the CBD though it must be said progress has been seen to be slow in implementation (Stenton, 2003) One of the possible answers to the problem of biopiracy is to encourage developing countries like Madagascar to require by law the issuing of bio-prospecting permits. This would ensure revenue for the country. Local involvement in the research process should also be strongly encouraged and the sharing of technological advances would possibly benefit both Madagascar and the pharmaceutical company involved (Stenton, 2003). In particular, the financial gains would be helpful to the local communities and would be incentives for them to share knowledge and know how (Stenton, 2003). The disadvantages of the above mentioned steps are that it is difficult to determine if the plant being studied will potentially yield a drug or be of any profit. So, it will be a barrier to potentially life-saving treatments for some people to hinder access to pharmaceutical companies (Stenton, 2003). This problem could of course be addressed by having a written agreement with the government of a country that if the properties of a plant are seen to be of therapeutic vale, that the country derives a certain percentage of its profits (Stenton, 2003). In conclusion, the question of whether it is worth investing in the pharmaceutical system of Madagascar must be addressed. It appears that it would be extremely beneficial to pharmaceutical companies to invest in developing countries in general and in particular Madagascar. Madagascar has a wealth of untapped resources in the form of its forests. Much of the species of plants there have never been documents and it is very likely that there are possible therapeutic benefits to be gained from a number of those plants. It must be noted that the biological organisms found in forests are however the property of the people of Madagascar and pharmaceutical companies would have o go through the proper protocols to access them. In addition, the encouragement of local labour to assist in projects would possible be of infinite value. The native people would possible by more receptive to helping the pharmaceutical companies if they felt there was some benefit to them and to their country. As it is difficult to predict the value of drug before its manufacture, it is a good idea for the government of Madagascar to have an agreement with pharmaceutical companies as to a percentage of the revenue that would be given to them should the drug be successful. This would avoid situations like in the case of the Rosy Periwinkle where the people of Madagascar got not revenue even though the pharmaceutical company is making millions of dollars. In short, it can be said that pharmaceutical companies investing in Madagascar would be mutually beneficial to both parties. The pharmaceutical company would benefit from having access to a vast number of flora that have not been seen in other parts of the world. In addition, they would be able to access information about how certain plaints are used to treat certain ailments but the native people and possibly capitalize on this. The people of Madagascar would benefit from pharmaceutical companies investing in their country primarily because of the revenue brought into the locals. In a country where 70%of the population lives on less than a dollar, setting up local projects would be very appealing. In addition, they would benefit from the exchange of knowledge and information and also the technological capacities of the pharmaceutical companies. In addition, the fact that pharmaceutical companies are interested in the biodiversity that Madagascar has to offer may lead to more conservation efforts being aimed at its rainforests which are unfortunately being deforested at the moment. References Cao, Shugeng and. Kingston, David G. I. 2009. Biodiversity conservation and drug discovery: Can they be combined? The Suriname and Madagascar experiences. Pharmaceutical Biology. 47(8).809–823. Students of the World, 2003. Countries of the World: Gross National Product (GNP). Online. Accessed at < http://www.studentsoftheworld.info/infopays/rank/PNB2.html>. [Accessed 10 May 2011]. Harper, Janice. 2005. The Not-So Rosy Periwinkle:Political Dimensions of Medicinal Plant Research. Ethnobotany Research and Applications. 3. 295-308. Mendelsohn, Robert and Balick,Michael,J. 1995. The Value of Undiscovered Pharmaceuticals in Tropical Rainforests. Economic Botany .49 (2). 223-228. Rasoanaivo, Philippe. 1990. Rain Forests of Madagascar: Sources of Industrial and Medicinal Plants. Science of Sustainable Development . 19(8). 421-424. Stenton, Gavin. 2003. Biopiracy within the Pharmaceutical Industry: A Stark Illustration of just how Abusive, Manipulative and Perverse the Patenting Process can be towards Countries of the South. Hertfordshire Law Journal.1(2). 30-47. Read More