MERO

Regional Workshop on Biotechnology in the Middle East and North Africa Sept 29-30, 2004 Cairo, Egypt

Background Paper: Health Biotechnology in MENA

By Professor Dahmani M. Fathallah Institut Pasteur de Tunis

Note 1: This paper is to be considered a working document, and will be finalized after .inputs from the workshop

Note 2: The views expressed in this report are those of the authors and workshop .participants, and do not necessarily reflect the views of IDRC

Abstract Introduction 1. Introduction to health biotechnology

1.1. Defining biotechnology 1.2. Overview of health biotechnology 1.2.1. Novel biotechnologies 1.2.2. Health care application 1.2.3. Status of health biotechnologies in MENA

2. MENA populations characteristics 3. Current health status and biotechnology in the region
3.1. Epidemiological trends 3.2. MENA needs for Biotech Products

4. Health biotech in MENA: Main issues and challenges

4.1. Health Biotech and the national system of innovation 4.1.1. Manifestations of the shortfall of effective innovation systems 4.2. Policy and strategy planning 4.2.1. New Institutions and bodies 4.2.2. Regulatory framework 4.2.3. Strategic planning and priorities setting 4.2.4. Mobilization of human resources 4.2.5. New incentives schemes 4.3. Financing of the innovation effort in MENA 4.4. Human resources 4.4.1. Brain drain and brain waste 4.5. Ethical and societal issues 4.5.1. Gene Therapy 4.5.2. Medical privacy and genetic discrimination 4.5.3. Cloning 4.5.4. Local traditions and values 4.6. Public perception of biotech 4.7. Challenges

2 3 4 4 5 5 5 8 10 11 11 12 13 13

14 15 16 16 16 17 17 18 20 21 22 22 22 22 23 24 25 5. Foresight as a tool to shape the future of health biotech in MENA 26 6. Role of IDRC in promoting biotech in MENA 27 Conclusion 29

ABSTRACT: Integrating modern biotechnology in their efforts to achieve national and regional development is a big challenge facing all MENA countries. As part of its efforts to explore how the International Development Research Centre (IDRC) could help the region overcome this challenge, IDRC is launching a regional consultation on biotechnology with emphasis on health and agriculture biotechnology. The overall aim of this consultation is to investigate how the Centre can contribute effectively to strengthening the regions biotech capacity. Toward these ends, IDRC is organizing a workshop aimed specifically at identifying and assessing the regions needs and priorities for research capacity building and policy making.. This paper is meant to serve as working material and provides some guidelines for the conferees to discuss the different issues that it raises with respect to health biotech. The paper presents the meaning of modern biotechnology that needs to be considered in the debate. Then it gives an overview of health biotechnology and presents the new technologies that are introducing a revolution in life sciences and their applications in health care. The current health status of the MENA region is also presented and the major needs in term of biotech products and services are discussed in this context. The paper tackles also some of the issues that seem to be the most relevant to the development of biotech in MENA. The issues raised in this paper include, at the governance level, the issue of the link between biotech development and the national system of innovation and the nature of the policy and strategies taken to favor biotech development. The issues of financing innovation and human resources that fuel biotech development are also discussed. The societal and ethical issues that biotech raises are discussed in the context of MENAs cultural background. The specific challenges that face the region in its effort to develop health biotech are presented. In conclusion, the paper presents a view on the role that IDRC might play in promoting biotech in the region, as well as suggestions for some specific immediate actions.

INTRODUCTION In the dawn of the third millennium, opposing pessimistic and optimistic visions of human evolution are being put forward. There are convergent views on the promises of biotechnology. Biotechnology is transforming every aspects of life and is becoming the milestone of economic and social development. Nowadays, It seems inconceivable not to integrate modern biotechnologies in the development of a modern agriculture or health system. Nobody can imagine what would have been the consequences of ignoring electricity, air transportation, telephone or any other technologies of the last century. The developed world has already entered the biotech era and is fully benefiting from this technological revolution. The technology, however, remains elusive for most of the developing world. Where does the MENA region stand in term of biotech development and particularly in Health biotech? What are the major currents and future needs? What are the mains obstacles that face the development of this field of activities? What can be effectively done to help moving biotech forward in the region? These are the many questions that IDRC is trying to answer as part of its commitment to help human development in this part of the world. Toward these ends, IDRC has taken the initiative to invite different stakeholders in the field of biotech from most of the MENA countries and organize a workshop to debate of health and agriculture biotechnology. The following paper is meant to give some working material for the conferees and contribute to launching a constructive debate that would hopefully lead to bringing out all of the relevant issues in the health biotech field in MENA. Another expected outcome is the identification of appropriate research approaches for IDRC to help in tackling these issues. This paper tries first to provide an accurate definition of modern biotechnology followed by an overview of the novel life science technologies that constitute health biotech, their applications and the benefits to the health care system. It also tries to present the MENA region and its population characteristics to better introduce the current health status in the region and define actual major needs. This paper also presents some of the issues that seem to be relevant to the development of health biotech. These issues are discussed in the context of the different MENA countries experiences to help IDRC identify the most relevant biotech developments in the region, set up priorities and define intervention niches and research approaches. The challenges that face MENA countries for the development of health biotech are also listed. To conclude the paper, the foresight experience in the field of biotech of some of the MENA countries is reported. The utility of foresight to explore the future of biotech in the region is suggested as potential fields of intervention for IDRC.

Abbreviations: AIDS: Acquired Immune Deficiency Syndrome. Biotech: Biotechnology. DNA: Deoxyribo Nucleic Acid. FDI: Foreign Direct Investment. GNP: Gross National Product. HIV: Human Immunodeficiency Virus IDRC: International Development Research Centre . KBE: Knowledge Based Economy. MENA: Middle East and North Africa. MSc: Master in Sciences. NSI: National System of Innovation. PhD: Philosophical High Degree. R&D: Research and Development. RNA: Ribo Nucleic Acid. S&T: Science and technology. WHO: World Health Organization

1. Introduction to health biotechnology 1.1- Defining biotechnology

By breaking the word Biotechnology into its root words: bio (the use of biological processes) and technology (to solve problems or make useful products), Biotechnology can be broadly defined as "using living organisms or their products for commercial purposes." As such, biotechnology has been practiced by human society since the beginning of recorded history in such activities as baking bread, brewing alcoholic beverages, or breeding food crops or domestic animals. A narrower and more specific definition of biotechnology is "the commercial application of living organisms or their products, which involves the deliberate manipulation of their DNA molecules" This definition implies a set of laboratory techniques developed within the last 20 years that have been responsible for the tremendous scientific and commercial interest in biotechnology 1, the founding of many new companies, and the redirection of research efforts and financial resources among established companies and universities. These laboratory techniques provide scientists with a spectacular vision of the design and function of living organisms, and provide technologists in many fields with the tools to implement exciting commercial applications. Why is biotechnology suddenly receiving so much attention? This is mainly due to the unlimited applications that the technological advances are allowing. Indeed, it became possible to use the smallest parts of organisms-their cells and biological molecules-in addition to using whole organisms to make new products and develop novel services A more appropriate definition in the new sense of the word is this: "New" Biotechnology is defined by the use of cellular and biomolecular processes to solve problems or make useful products. According to this development trend, a better handling on the meaning of the word biotechnology would be to simply consider its plural form, biotechnologies instead of the singular noun, biotechnology. Hence, biotechnology can be defined more accurately as a collection of technologies that capitalize on the attributes of cells, such as their manufacturing capabilities, and put biological molecules, such as DNA and proteins, to work for us.

Battelle-technology Forecast: file :///C/WINDOWS/TEMPS/technology2020.htm

1.2. Overview of health biotechnology

1.2.1 Novel biotechnologies In line with the most exhaustive definition of biotechnology, we herein present a listing of the technologies, which in the beginning of the third millennium are introducing a revolution in the health system as a whole. These technologies 1 will affect the MENA region like any other part of the world not only in the way how health care will be provided but also the productive sector and even with regard to the social, cultural and ethical issues it raises. Bioprocessing: It is the oldest of the biotechnologies. It became "bioprocessing technology" as the molecular details of cell processes were uncovered. Bioprocessing technology uses living cells and their manufacturing machinery to produce desired products. Cellular Technology: It consists of culturing cells outside of a living organism: in vitro. Mammalian cells and insect as well as hybridoma cultures, for the making of monoclonal antibodies, are the most developed. Cellular technology has also allowed cellular and animal cloning. Recombinant DNA Technology: It allows molecular cloning, mainly gene cloning, as well as the manipulation of DNA sequence. Protein Engineering: It uses DNA cloning and genetic engineering in combination with bioprecessing technology for the production in vitro of novel proteins. Biosensors: It couples the knowledge of biology with advances in microelectronics to make products and devices useful in a variety of fields Nanobiotechnology: It joins the breakthroughs in nanotechnology to those in molecular biology. Microarrays: Microarray technology is transforming laboratory research because it allows us to analyse tens of thousands of samples simultaneously. It includes DNA, protein, tissue, whole-cell and small-molecule microarrays. 1.2.2. Health care applications The tools and techniques of biotechnology listed above are allowing significant progress at different levels ranging from major discoveries in basic life sciences research to discovery of new state of the arts products that are revolutionizing the way health care is provided [Products tailored to individuals, novel more potent and safer vaccines, novel more accurate and cheaper diagnostic tools]. These technological advances are also leading to novel therapeutic approaches. In human health care, biotechnology products include quicker and more accurate diagnostic tests, therapies with fewer side effects and new and safer vaccines. The following briefly outline some biotech applications in the field of health: A- Diagnostics:

We now use biotechnology-based tests to diagnose certain cancers, such as prostate and ovarian cancer, by taking a blood sample, eliminating the need for invasive and costly surgery. In addition to diagnostics that are cheaper, more accurate and quicker than previous tests, biotechnology is allowing us to diagnose diseases earlier in the disease process, which greatly improves a patient's prognosis. Proteomics researchers are discovering molecular markers that indicate incipient diseases before visible cell changes or disease symptoms appear. The wealth of genomics information made available by the Human Genome Project will greatly assist doctors in early diagnosis of hereditary diseases that previously were detectable only after clinical symptoms appeared. Genetic tests will also identify patients with a propensity to diseases, such as various cancers, osteoporosis, emphysema, type II diabetes and asthma, giving patients an opportunity to prevent the disease by avoiding the triggers, such as diet, smoking and other environmental factors. B- Therapeutics: Biotechnology is making possible improved versions of today's therapeutic regimes as well as treatments that would not be possible without these new techniques. Biotechnology therapeutics is used to treat most if not all diseases. The therapies discussed below share a common foundation. All are derived from biological substances and processes designed by nature. Some use the human body's own tools for fighting infections and correcting problems. Others are natural products of plants and animals. The large-scale manufacturing processes for producing therapeutic biological substances also rely on nature's molecular production mechanisms. Here are just a few examples of the types of therapeutic advances biotechnology now makes feasible. Using natural products as therapeutics: Many living organisms produce compounds that coincidentally have therapeutic value for us. Recombinant DNA technology and cellular cloning now provide us with new ways to tap into natural diversity. The ocean presents a particularly rich habitat for potential new medicines. Marine biotechnologists have discovered organisms containing compounds that could heal wounds, destroy tumours, prevent inflammation, relieve pain and kill microorganisms. Using biopolymers as medical devices: Biopolymers are biological molecules that can serve as useful medical devices or provide novel methods for drug delivery. Because they are more compatible with our tissues and our bodies absorb them when their job is done, they are superior to most manmade medical devices or delivery mechanisms. For example, hyaluronate, a carbohydrate produced by a number of organisms, is an elastic, water-soluble bio molecule that is being used to prevent post surgical scarring in cataract surgery, alleviate pain and improve joint mobility in patients with osteoarthritis and inhibit adherence of platelets and cells to medical devices, such as stunts and catheters. Replacing missing proteins: Some diseases are caused when defective genes don't produce the proteins (or enough of the proteins) the body requires. It is now possible to use recombinant DNA and cell culture to produce the missing proteins.

Using genes to treat diseases: Gene therapy is a promising technology that uses genes or genes related molecules such as RNA, to treat diseases. For example, rather than giving daily injections of missing proteins, physicians could supply the patient's body with an accurate instruction manual i.e. a non defective gene, correcting the genetic defect so the body itself makes the proteins. Other genetic diseases could be treated by using small pieces of RNA to block mutated genes. Medical researchers have also discovered that gene therapy can treat diseases other than hereditary genetic disorders. They have used briefly introduced genes, or transient gene therapy, as therapeutics for a variety of cancers, autoimmune disease, chronic heart failure, disorders of the nervous system and AIDS. Cell transplants: Approximately 10 people die each day waiting for organs to become available for transplantation. To circumvent this problem, scientists are investigating how to use cell culture to increase the number of patients who might benefit from one organ donor. Liver cells grown in culture and implanted into patients kept them alive until a liver became available. Other conditions that could potentially be treated with cell transplants are type 1 diabetes, heart infarction, cirrhosis, epilepsy and Parkinson's disease. Tissue engineering: Tissue engineering combines advances in cell biology and materials science, allowing us to create semi-synthetic tissues and organs in the lab. These tissues consist of biocompatible scaffolding material, which eventually degrades and is absorbed, plus living cells grown using cell culture techniques. Stem cells: Stem cell research represents the leading edge of science, a biotechnology method that uses cell culture techniques to grow and maintain stable cell lines. Stem cells are cells that have not yet differentiated. By starting with undifferentiated adult and embryonic stem cells, scientists may be able to grow cells to replace tissue damaged from heart disease, spinal cord injuries and burns, and to treat diseases such as Parkinson's Disease, diabetes and Alzheimer's Disease by replacing malfunctioning cells with newly differentiated healthy cells. This process of culturing a line of genetically identical cells to replace defective cells in the body is sometimes referred to as therapeutic cloning.

C- Vaccines: Biotechnology is helping us improve existing vaccines and create new vaccines against infectious agents, such as the viruses that cause cervical cancer and genital herpes. Biotechnology vaccine production: Most of the new vaccines consist only of the antigen, not the actual microbe. The actual biotech vaccine is made by inserting the gene that produces the antigen into a manufacturing cell, such as yeast. During the manufacturing process, each yeast cell makes a perfect copy of itself and the antigen gene. The antigen is later purified. By isolating antigens and producing them in the laboratory. This method also increases the amount of vaccine that can be manufactured because biotechnology vaccines can be made without using live animals. Using these techniques of biotechnology, scientists have developed antigen-only vaccines against lifethreatening diseases such as hepatitis B and meningitis. 8

DNA vaccine: Recently researchers have discovered that injecting small pieces of DNA from microbes is sufficient for triggering antibody production. Such DNA vaccines could provide immunization against microbes for which we currently have no vaccines. DNA vaccines against HIV, malaria and the influenza virus are currently in clinical trials.

Biotechnology is also broadening the vaccine concept beyond protection against infectious organisms. Various researchers are developing vaccines against diseases such as diabetes, chronic inflammatory disease, Alzheimer's disease and cancers. D- DNA Fingerprinting: DNA fingerprinting, which is also known as DNA typing, is a DNA-based identification system that relies on genetic differences among individuals or organisms. Every living organism (except identical twins) is genetically unique. DNA typing techniques focus on the smallest possible genetic differences that can occur. It is used for any task where minute differences in DNA matter, such as determining the compatibility of tissue types in organ transplants, detecting the presence of a specific microorganism, establishing paternity and identifying individual remains. Paternity testing: Paternity determination is possible with DNA typing because half of the father's DNA is contained in the child's genetic material. Using restriction analysis, DNA fingerprints of the mother, child and alleged father are compared. The DNA fragments from the mother that match the child's are ignored in the analysis. To establish paternity, the remaining DNA fragments in the child's DNA fingerprint, which have been inherited from the biological father, are then compared to the DNA sequences of the alleged father. 1.2.3 Status of Health biotechnologies in MENA Where does the MENA region stand with regards to this technological progress? All the technologies presented above have broad applications that extend to other sectors including agriculture, environment and other industrial fields. As far as the health sector is concerned, their effective implementation at the R&D or industrial level in MENA is rather at an embryonic stage. Indeed, if we consider the economic outcome, no biotech activity whether emanating from a proper innovation system or through effective transfer of technology 2 has been significantly developed in any of the MENA countries to date. As a result, no local biotech industry that supplies such product to the regional market is significantly developed and this market relies almost exclusively on importation. As a consequence, access of the MENA populations to such technologies and their derived products [new biotech-derived drugs and vaccines, diagnostic kits and novel therapeutical procedures] for health care, is uneven and varies from country to another according to the financial resources of each country. Furthermore, access to biotech-derived products and health services
2

Djeflat, A.: The management of technology transfer: Views and experiences from developing countries. International Journal of Technology Management, Vol. 3, N1/2 pp. 149-166, London 1988.

varies according to the economic level of the different social groups within each country (poor versus rich). Some of the MENA countries are classified as being dynamic users of these technologies, which implies that a certain level of awareness on the importance of such technological progress has been reached. This may prepare those countries to enter the next phase of being producers of such technical advances in health biotechnology. Tunisia, for instance, has integrated some DNA testing technologies particularly in forensic and paternity determination use. Algeria, Egypt and Jordan have acquired some recombinant vaccine manufacturing technologies. At the academic level these new technologies are being taught in most of the learning institutions throughout the region and some R&D institutions are initiating research programs to develop health biotech related to local health problems such as the Bilharzias Institute and VacSera in Egypt, and the Institutes Pasteur in Morocco, Algeria and Tunisia. It is clear that modern biotechnologies in the health field could hold the key to solving many of the region health care and other related problems that emanate directly from poverty and uneven wealth distribution. The crucial issue remains the equitable access by all to the modern-biotech-generated products. Because most of the new biotech products are often the results of lengthy and costly research and development activities, (see Figure 1) they are economically out of reach for a vast majority of social groups within the region.

Figure 1 Not withstanding the uneven access to biotech health products throughout the region, some efforts to develop a biopharma industry are being made in Algeria, Egypt and Jordan. However, there still a long way to go before the region fully enters the era of modern health biotechnology industry. Furthermore, the world is currently experiencing a shortage in manufacturing capabilities of most of the strategical products such as vaccines or recombinants blood products or other replacement proteins. This shortage of supply is a consequence of an enormous market pull and the difficult barriers of entry to such industry due to capital-intensive investments, high costs of R&D and extremely stringent manufacturing rules and marketing regulations set up by the international scientific 10

community 3. It is getting more and more difficult to find in the global market enough products that meet the demand t for safe use. Hence all of the MENA countries are at risk for not being able to have even a limited access to such essential biotech products. Egypt has experienced such a situation for recombinant insulin in the early 2000, before adequate steps were undertaken to overcome such shortages. Hence, development of local or regional capacity for the production of biotechderived pharmaceutical products will definitely lower the cost of such products, which necessarily leads to a more horizontal use of such products and breaks the cycle of dependency on expensive and limited supplies in the international market Furthermore, national policies are required to ensure equal access to this technology and its benefits by all segments of Society. It is getting more and more obvious that health care will increasingly rely on biotech products and technologies. For MENA, it is risky to keep relying entirely on imported products. The danger of this risk materialized in the early nineties when it was demonstrated that blood derived products imported from Europe in the Maghreb countries have caused HIV contamination to patients who have taken them, resulting in several needless deaths. This emphasizes that in the absence of a local biotech industrial experience and the accompanying controls and regulations activities, such accidents can hardly be prevented.

2. MENA populations characteristics

The MENA countries have an estimated population exceeding 350 millions 4. An interesting feature of this population lies in its genetic diversity. Within this region lives a large variety of ethnic groups with a predominant Neolithic origin. The diversity has been conserved through traditional inbreeding (high rate of consanguineous marriages). The later had impacted the pattern and incidence of genetically transmitted diseases in the region. The recent development of biotechnology in the field of human genome analysis and genetic fingerprinting as described above could benefit the region, considering that future cures will be tailored to accommodate the genetic background of individuals. The regions actual annual population growth rate is 2.7 percent as compared to the 1.5 percent for the less developed world as a whole excluding sub-Saharan Africa. It is the second highest population growth rates in the world, where it once exceeded even that of Sub-Saharan Africa's 4. In the 1990s, population growth slowed down slightly. In the last decade economic growth was slower than in any region, except Sub-Saharan Africa and the transition economies of Europe and Central Asia. In 2000-2001, GDP per capita grew by only 1 percent. Since 1990 the percentage of people living below $1 per day has not improved, and the percentage living below $2 per day has increased from 21 to 23 percent of the population.

- Zahlan, A.B.: The Maghreb, Innovation and Globalisation. 3rd international Conference, Maghtech 98, April 1998, Tunisia 4 Arab States Country Profiles: http://www.prb.org/template.cfm? template=InterestDisplay.cfm&Interest

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Another interesting characteristic of this region is the juxtaposition of the developed world with the developing world. Oil booms in the region during the 1970s boosted the region per capita GNP and allowed investment in education, transportation, urban sanitation and other infrastructure that affect poverty and health. At 68, average life expectancy for both sexes, in the region is relatively high. Infant mortality has been steadily reduced and primary school enrollment has increased although female youth illiteracy remains at 25%. The region has a fairly well developed infrastructure. Over 85 percent of its population has access to improved sanitation facilities and water sources; and 66 percent of its roads are paved. But with only 1,429 cubic meters of freshwater resources available per capita, the Middle East and North Africa ranks well below the average of other regions. The region has also the highest military expenditure in the developing world: 7 percent of GDP, more than double the spending of the next highest region, Europe and Central Asia. However these general improvements mask substantial disparities among countries, sub regions, between the urban and the rural, ethnic groups and women and men, etc... The region continues to face significant public health and environmental challenges.

3. Current health status and biotechnology in the region 3.1. Epidemiological trends:
According to a study emanating from the Centers for Disease Control and Prevention5 (CDC, Atlanta, Georgia, USA), one characteristic of MENA economic development is a shift in the relative contributions of communicable and chronic diseases to mortality. As populations become more affluent, the so-called diseases of affluence become more prominent. The epidemiological situation regarding infectious disease is summarized below: HIV: It is clear that HIV infection prevalence in MENA is very low. It was estimated at 0.2% to 0.4% in 2003. Systematic surveillance however remains inadequate, making it very difficult to deduce accurate trends. UNAIDS estimated the number of people who acquired HIV in 2003 was between 43,000 to 67,000, bringing the estimated number of people living with AIDS between 470,000 and 730,000. The epidemic claimed between 35,000 to 50,000 lives in 2003. The most affected country in the region was Sudan, specifically the south region. In most other countries of the region, HIV spread appears to be nascent although scant surveillance data in several countries could mean that serious outbreak in certain populations may be going unrecorded. Tuberculosis, Polio and Measles: A WHO report 6 released in 2002 showed that the incidence of tuberculosis is low (90 per 100,000 people; Figure 2), as a result of prevention trough mass vaccination and better hygiene. Like in other parts of the world, WHO has also worked efficiently in the region to eradicate poliomyelitis using different kinds of vaccine and eradication of measles is underway.

5 6

CDCs Global Health Activities in the Middle east and North Africa. http://www.cdc.org WHO report, World health report, 2002, Geneva , Switzerland

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Number of people affected by tuberculosis

Figure 2 Rabies: Rabies is a zoonosis prevalent in the region and is controlled in most of the countries mainly by animal vaccination, especially stray dogs. Hepatitis: The epidemiological situation concerning Hepatitis B, C and others types is rather alarming. Incidence of these viral infectious diseases are among the highest in the world and some countries of the region have incidences that climb up to 20% of sero positive people. Hepatitis B vaccination has been introduced in the region soon after the development of a genetically engineered recombinant vaccine but is unevenly applied. Parasitic diseases: The MENA region also suffers from a pattern of parasitic diseases ranging from Leishmania (most countries) to Bilharzias (Egypt and Sudan) for which no vaccine is available at this time. 3.2. MENA needs for health biotech Products: The shift in the epidemiological profile has brought chronic diseases such as cardiovascular disease, cancer, diabetes, neuro-degenerative disorders and genetically transmitted diseases to the status of health concerns. This situation is the consequence of the improvement of the primary health care throughout the region. Genetic diseases that are common in the all of the MENA countries were neglected and considered as fatality because they were poorly understood and lacked accurate diagnosis. Thanks to the advances in genomics and DNA based early diagnostic and prenatal diagnosis, such diseases are getting the attention of the health care authorities. Because of the economic burden of such epidemics on families and communities which is enormous in the majority of the regions countries, the overall recognition of the need for more effective drugs and far-reaching diagnostic and prevention efforts has grown in the region Most of the MENA countries rely heavily on imported vaccine and other needed drugs for their prevention programs and treatment. 13

The epidemiological trends combined with the high population growth, the current socio economical situation along with the improvement of educational level are as many elements in favour, not only of a growing need for biotech products and services in the region in the near future, but also for an equitable access to such products and services. The issue of self-containment as far of such strategical products are concerned raises the crucial question of what need to be done in order to reach this objective? Meanwhile specific information and education of the general population especially in remote areas, on the different issues raised by the development of health biotech and the impact on individual and social groups lives need to be structured and provided in an organized way.

4. Health biotech in MENA: main issues and challenges

Considering that biotechnology is the legitimate infant of knowledge-based societies, the main challenge for the region is to undertake the necessary steps to fill this strategic gap and to adopt a knowledge-based economy, with health biotech as a strategic choice. The knowledge-Based Economy KBE is defined as an economy where knowledge (codified and tacit) is created, acquired, transmitted and used more effectively by enterprises, organizations, individuals and communities for greater economic and social development7. Four components define such economy: An institutional regime, An educated and entrepreneurial population A dynamic information infrastructure An efficient system on innovation.

A national system of innovation (NSI) appears thus as one of the prerequisite and one of the key elements for health biotech to be successful.

4.1 Health Biotech and the national system of innovation

A NSI comprises several institutions and competencies interacting in order to assimilate the growing stock of global knowledge in order to adapt it to local needs and use it to create new knowledge and technologies. In most of the MENA countries the overall level of awareness of the fundamental role of sciences and technologies in development, was relatively low. Thus the basic ingredient for setting up the ground for a NSI was missing. A NSI depends to a larger extent on the effective implementation of R&D activities. The driving forces for such policy include: engagement in programs of scientific research, both basic and applied, massive transfer of up to date technologies from advanced countries and substantial investments in training locally and abroad.

Lahlou, M.: Science and Technology and society: What makes the culture of innovation. In G. Zawdie&A. Djelfat technology & transition: the Maghreb at the crossroad Frank Cass, London, 1994, pp.61-68.

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The National systems of innovation developed in MENA are different from country to another but most of them are far remote from the above definition. Countries such as Tunisia, Egypt, Morocco, Jordan and Algeria have made attempts to build an efficient NSI system8. They tried to integrate some of the necessary components, resulting in the formation of a large pool of human resources and the creation of a number of R&D institutions in the health field however these efforts have so far failed to deliver a health-oriented biotechnology that is capable of translating into innovation and technological progress of socio economical significance. 4.1.1. Manifestations of the shortfall of effective innovation systems in MENA Analysis of the main indicators underlying the performance of NSI shows the scarcity of innovation in the region: Evolution of the number of registered patents 9: The evolution of the total number of registered patents shows declining trends in Algeria, a slight increase in Morocco and Egypt and an important increase in Tunisia. As far as specific sectors are concerned, the situation differs from one country to another. In Morocco for instance, the most active field is the health sector (16 % of all registered patents). However, these figures translate into an overall insufficiency when compared with figures from small countries such as Switzerland or even Turkey, which reached 722 registered patents in 1995. Furthermore, foreign firms held a large percentage of the registered patents. Intellectual property protection: Property protection rights and institutions are highly underdeveloped within the MENA region. Most the region countries have looked unfavorably into this issue that in turn affects an efficient NSI because it constitutes a significant incentive for foreign investors to transfer technology and generate maximum spillover effects. Classification according to The Intellectual property rights index IPRI 10 that ranges between 0 an 5 and indicates the strength of laws in defending intellectual property rights locally, had at some time, pinpointed some MENAs countries as being centers of counterfeits. However this ranking never concerned the health biotech industry. Scientific publications 11: Despite a steady 10% annual rate increase in the number of scientific publications in MENA in the last two decades (the total number went up from 460 in 1967 to 7,000 in 1995 with one third approximately from the health field), scientific production remains highly insufficient as compared to countries such as India, Brazil or South Korea. More indicative is the ratio of publication to population that does not exceed 20.4 for the Maghreb and 26 for the Arab world as compared to 42 in Brazil and 144 in South Korea. These publications emanate mostly from universities and are mostly disconnected from the
8

Alcouffe, A.: National Innovation System: The case of the Arab Maghreb union. In G. Zawdie & A. Djelfat technology & transition: the Maghreb at the cross road Frank Cass, London, 1994, pp.61-68 9 Lahzami,Ch.: Place et conditions de linnovation technologique dans les pays du maghreb lhorizon du XXIe sicle 3rd international Conference Maghtech 98, April 1998, Tunisia. 10 - Maskus, K.E. & Penubarti, M. (1995). How trade-related are intellectual property rights. Journal of International Economics, 39, pp.227-248 11 Mrayati,M. Major initiatives in implementing S&T strategies: S&T Parks, Incubators and Innovation. Conference on Capacity Building initiatives for the 21st century ESCWA, Beirut 2000.

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real engineering and biotech sphere. Furthermore, they are rarely published in highly reputable journals. Indeed publications in international journals on S&T journals remain relatively limited with 0.32% for MENA as compared to 0.96% for Latin America and 2.9%for Asia. According to these statistics, it seems that MENA scientists perform better in chemistry and physics. It should be noted however, that this situation might not reflect the real propensity to publish scientific findings as most of the MENAs scientists confess being subjected to discrimination, and suffer from barriers of entry to the S&T publication sphere. Presence in scientific conferences12: In the early nineties [1990-1994] the presence of scientists from the MENA countries in international conferences as reflected by the number of contributed papers (1%) was very low. In the same period, the region hosted only 0.1% of the worlds conferences. It should also be taken into consideration that the steadily increasing fee for participation in scientific meetings with the difficulty in traveling [visas procedures] are some important obstacles to larger participation of MENAs scientists to international scientific events.

4.2 Policy and strategy planning

Like the rest of the world and the developing countries in particular, MENA countries will soon face increasing competition, vanishing trade barriers, more stringent intellectual property regimes and deeper concern for the environment. Trends in all these areas are expected to pose serious challenges for fragile components in the socio-economic systems of the region, such as health. Policy-makers will have to seriously address these challenges. While policies and strategies developed for the classical health system to face the sanitary situation have been satisfactory in most of the MENA countries, health biotech poses a different set of problems and the policies, and strategies put forward in this domain remain inadequate. This is mainly because of the fact that health biotech development is dependant primarily on the development of S&T as a whole13. While most MENA countries are now stressing the need for innovation and technological progress, not all of them are clear as to what strategies should be adopted to reach this goal and enter the knowledge economy era and acquire a significant competitive edge. The situation is however different from one country to another. For latecomers to biotechnology like MENA countries, the experience of newly industrialized countries, where governments played a key role, appears to be more relevant to MENAs present situation. The risk of state intervention should, however, be weighed against the risk of passivity. While the role of governments appears paramount, it is also becoming clear that public-private collaboration remains an important pre-requisite for latecomers to have a chance to compete in the new technology-based competitive markets including the huge market of health biotech. Successful policies have taken measures that include 14: New institutions and bodies.
12

The British Library 1994 Index of conference Proceedings Cooper, Ch: New technologies and changing trends in development global perspectives; In G.Zawdie &A. Djelfat Technology and transition: The Maghreb at the cross road Frank Cass, London, 1994, pp.61-68.
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Regulatory frameworks. Strategic planning & priorities setting. Mobilization of human resources. New incentives schemes.

4.2.1. New institutions and bodies: Various bodies were initiated in MENA in some countries like Algeria, Tunisia, Morocco, Egypt and Jordan in the early nineties and included new specialized institutions, R&D coordinating institutions and ministries or ministerial delegates. Most have built S&T policies and some strategies for investment in innovation. However, no significant successes in linking up R&D to markets needs were observed to date. 4.2.2. Regulatory frameworks: Setting up of the these new institutions and bodies was concomitant in most of the MENA countries with the promulgation of sets of laws in favor of the development of S&T with direct links to R&D. In Tunisia, the novel code for investment includes a series of measures that encourages investment in S&T and defines the venture capital as a financial tool to invest in innovative projects. According to the 1994 decree revised 15 in 1996, universities are allowed to contract directly with local or foreign institutions for the purpose of undertaking studies, research, consultancy work as well as seminars, training sessions or colloquia, with the costs of the services being fixed jointly by the two parties Parts of the revenue generated are given to the academic personnel involved (up to 40%). The law promulgated in Algeria 16 in 1998 is geared specifically towards enhancing capability to innovate, including public enterprise and private SMEs. In Egypt, strong patents, trademarks and copyright protection legal system was set up to improve Egypts access to the best available foreign technology, and encourage innovation by attracting foreign direct investment and joint venture. 4.2.3. Strategic planning and priorities setting: Most of MENA countries have their research and technology development plan covering periods of four to five years 17. These plans are aimed at technological mastery, research promotion and the strengthening of applied research. Most of them include ingredients such as multistage policy for S&T integration into economic policy, strengthening the links between the private sector and academia and subsidies for R&D given to enterprises involved in innovation. Concerning priorities setting, past policies have been characterized by a total lack of clear perception of priority areas. Despite efforts to overcome this weakness, priorities setting is still loose and most of the countries are trying to tackle all fields
14

Djeflat, A.: S&T policy planning and dialogue in African Economy UNECA/IDEP/ATPS, Workshop Intern. Institute for planning and development: Dakar, Senegal, January 27-31, 1997, pp102 15 Law of orientation of scientific research and technological development, decree n94-536 of March 10, 1994 and decree n96-6 of January, 1996 and decree n99-11 of January 1999. Official Journal of Tunisia 16 Loi n98-11, dorientation et de programme a projection quinquennale sur la recherche scientifique et le dveloppement technologique : Algeria, 1998-2002 17 Quasim, S. Research and Development in the Arab states: A new commitment Symposia on NTCIs, ESCWA, Beirut, March 2000, p23.

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of biotechnology, regardless of their real needs and potential. Focusing on sectors such as agriculture and health seems obvious, and the development of appropriate human resources and industrial competitiveness should be oriented towards these sectors. 4.2.4. Mobilization of human resources: The issue of mobilization of human resources that was clearly neglected in the past is now a central preoccupation of policy-makers. The use of foreign technical assistance is not as systematic as in the past. A new approach is now being adopted to mobilize and reinforce S&T potential. This is done through Centers of excellence planned in several MENA countries notably in the Maghreb: 10 in Morocco, 6 in Algeria and 5 in Tunisia, with at least one specializing in life sciences 18. Mobility of people from the public to the private sector or vice versa is encouraged in these countries. Furthermore, a significant effort is being made by most of the regions countries to mobilize scientists from the diaspora, i.e. those living in Europe or North America by involving them predominantly in teaching and consultation. 4.2.5. New incentives schemes: To promote innovation and R&D activities, most of the MENA countries are creating a variety of incentives. The most common incentive is the R&D specific taxation concession, which seems to be also the most effective. This support includes various taxes exemptions, reduction of custom duties for imported equipments and tax reduction for re-invested profits. In Tunisia, a new law promulgated in the year 2000 brings 18 in more incentives in the field of patenting by giving the possibility and the priority for an employee to valorize the invention themselves. Furthermore, the government has set up the PIRD [prime pour les investissements en R&D], which is a grant that can go up to 400k USD to promote and encourage R&D in the private and public sectors. Several MENA countries prizes and awards were designed as incentives to promote innovation and creativity, and to implant the innovation spirit. In Algeria, there is a presidential prize for Arab medicine, in Jordan, the El Hassan Bin Tallal award for scientific excellence, the Hisham Hijjawi prize for applied Sciences, and the Abdul Hameed Shoman prize for young Arab researchers. In Egypt, the Academy of scientific research and technology gives several prizes and awards 19. Despite all the efforts made by most of the MENA countries in putting forward policies and strategies to favor innovation, the overall results have fell short well below the minimum level of expectation. This shortage in expected outcome is a preoccupation for all the governments. Preliminary analysis of this shortfall of S&T policies points to failure of policy implementation as being the main reason for this situation. However, MENA countries need the help of the international community to define accurately the underlying causes of this failure and to take the necessary actions to remedy this situation. Organizations such as IDRC could help in this task.

18 19

La Presse, News paper, October 1998, p.7 Yousri, M.: Initiatives undertaken to promote dissemination, implementation and development of science and technology in Egypt: case study: ESCWA/TECH/2000/WG.1/9, 2000

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4.3- Financing of the innovation effort in MENA

The issue of financing innovations in health biotechnology as a priority sector was never clearly addressed in MENA, despite the emergence of the health sector as a strategical one. This situation is the consequence of the limited awareness of the importance of innovation and a policy vacuum characterized by the lack of clear orientation. Despite the efforts made by countries like Algeria, Tunisia & Morocco in the Maghreb and Egypt, Syria and Jordan in the Mashrek, R&D expenditure as a percentage of GNP remain insufficient in comparison to developed countries, as shown in the table below. R&D expenditure per inhabitant in MENA countries also compares unfavorably with developing countries. This is in spite of the fact that the economic demand for new technology remains relatively important as shown by the deficit in technological balance of payment (TBP) that reached 10 billion USD in 1995 (more recent figures are not available).
Evolution of the average expenditure ,, , in R&D as a percentage of GNP between 1994 and 2002

ND not determined

Country

Mauritania 0.26 - ND Morocco 0.2 to 0.45% In all Algeria 0.3 to 0. 70% Tunisia 0.3 to 0.82% Egypt 0.22 to 0.60% Jordan 0.28 to 0.64% Syria 0.22 to 0.58% Saudi Arabia 0.12 - ND UAE 0.04 - ND Kuwait 0.22 to 0.4% Qatar 0.06 - ND Oman 0.05 - ND Bahrain 0.04 - ND Japan 3.05 to 3.78% Germany 2.66 to 3.12% France 2.25 to 2.72% MENA countries, the budget allocated to R&D is almost entirely spent on wages and salaries of the research personnel. In Morocco, for instance, the proportion reaches 95%. Furthermore, the governments share of R&D funding averages 89% in the region as a whole. This share amounts to 100% in 7 countries and ranges from 67% to 97% of total R&D spending in 11 others. Public funding remains thus relatively high as compared to countries like South Korea or Japan where it does not exceed 20 to 25%. As far as the private sector is concerned, efforts made in the area of R&D remain relatively weak with only 10% of the total funds coming from enterprises budget. Nevertheless, the trends show that private funding has been growing at a higher rate than public funding. However, the lack of venture capital or risk capital, which is the modern and most adequate type of 19

financing innovation, constitutes a major handicap to development of a modern industry, particularly in the field of health biotech. This situation is the consequence of the low risk-taking attitude of the private sector in the whole region. Indeed, several financing groups emerged throughout MENA claiming the label of venture capitalist. However, a closer look at these institutions shows that they all function according to the classical banking system, with a very shy or a complete lack of an attitude toward the risk factor. It should also be mentioned that in the field of health biotech, investing in innovation is capital intensive, with a long delay in the return on investment if any. The sharp entrepreneurship crisis observed in the MENA region particularly in the field of health science is a manifestation of this financing trend. Resorting to foreign financing would be facilitated by necessary domestic financial reforms, covering organization and management of financial projects. The measures taken by MENA governments to attract foreign investments 20 [FDI, joint-venture, partnership etc] include more liberal investment codes and reflect the ever-growing need for foreign technology. In all investment codes, technology transfer and innovation capabilities as well as the acquisition of state-of-the-art technology and spillovers to local firms are among the main expectations from foreign investments. Despite the fact that FDIs have been growing almost exponentially in the whole MENA, the region still compares poorly with other parts of the world, namely with South East Asia: a mere 7.2 billion USD in 1998, while South east Asia received 77.2 billion USD the same year. MENA attracts now only 2.5% of total net foreign investment to developing countries 21. With the limited flows of FDI to the region, it is difficult to expect tremendous positive effects on technology transfer in MENA countries. However, even in countries that attracted a great deal of foreign investments, the results also do not appear to be satisfactory22. A substantial number of new technologies were introduced in the region over the last three decades, yet most of the innovation required took place outside, and not within the region. This may be the reason why some skepticism as to the ability of foreign investment to built domestic technological and innovative capabilities is prevailing2. This raises the issue of technology transfer mechanisms: Can technology be effectively transferred? Are there alternative ways to acquire technologies? Are all the technologies relevant? Moreover, given the disparities in available financial resources within the region and mainly the resources devoted to R&D, financing of innovation will greatly benefit from a clear perception of priority areas and implementation of appropriate measures geared towards overcoming the weakness of the actual financing system.

20

Bellon, B.: Les investissements directs trangers et les politiques de development industriel : Effets deviction ou avantages construes. Reseau EMMA, Commissariat gnral du Plan, Paris, Mars, 1997, p.7 21 Bnassy-Qur, A. et al. : MENA countries in the competition for FDI : Designing an exchange rate strategy. EU, Paris, 1999 22 World Bank- IDF project WB 28836 (1997): An Overview of study on improving S&T policy Management in Egypt

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4.4 - Human resources

The issue of developing human resources has also been the primary concern of most of MENAs governments. Large efforts have been made over the last four or five decades to remedy the situation of shortages of scientific capabilities by several actions, the most significant one being the reinforcement of training of graduates with the belief that higher education level is central to skills formation and creativity, both necessary ingredients for innovation. Most of the countries in the region have been spending a high percentage of their GNP in education. This policy, however, lacked clairvoyance and planning, and ended up by yielding a large number of highly educated and specialized human resources not adapted to the countries specific needs and hence unable to gear innovation toward innovation and a KBE. As an illustration of the lack of vision in building an adequate human resource capacity: in MENA the number of graduates in natural sciences and technology remained small, while those in social sciences, art and humanities represented between 50% to 60% of the total number of graduates of higher education23. Compared to Europe, the rate of graduates per thousand in MENA is half as much, and yet the number of people involved in R&D is on average 10 to 20 times less than in Europe. Indeed, for all countries of MENA, less than 400 engineers per million inhabitants are involved in R&D, while Europe has 1750. There is no significant evidence that higher education helped to meet development needs through the production of relevant skills and the provision of R&D support24. Education policy is not matched with economic policy, hence the impossibilities for growth reversal30. This situation yielded a high level of graduate unemployment that is now one of the central preoccupations of MENA countries25. Vocational training has long been neglected in most MENA countries26. The case of Egypt is worth mentioning because paradoxically, the increase in qualifications did not necessarily improve the possibilities for the development of local capabilities. It rather enhanced the propensity to emigrate. Emigration or brain drain is also the result of another weakness of the human resources system in MENA, that consists of the low moral and material status of researchers and their marginalization, as well as their low degree of stability and inadequate motivation, poor research conditions and the indigent state of universities. 4.4.1. Brain drain and brain waste:
23

Djelfat, A.: Technologie et systme ducatif en Algerie; 3rd International Confrence Maghtech 98, April 1998, Tunisia. 24 Lahlou, M.: Performance of the Education System and profile of Industry demand for skills in Morocco. In G. Zawdie, G.: Tertiary education and technological progress in transactional economies. In G. Zawdie&A. Djelfat technology & transition: the Maghreb at the crossroad Frank Cass, London, 1994, pp.61-68. 25 Lahlou, M.: La problmatique de lemploi et de la pauvret et le programme dajustement structurel au maroc. Revue CENEAP, n17, pp.35-60 26 Zawdie, G.: Tertiary education and technological progress in transactional economies. In G. Zawdie&A. Djelfat technology & transition: the Maghreb at the crossroad Frank Cass, London, 1994, pp.61-68.

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Like many other parts of the developing world, the MENA region suffers a t significant brain drain. The emigration level of Arab scientific manpower (MSc and PhD levels) has reached levels of the order of 80% in many countries, to the benefit of industrialized countries mainly. A rough estimation of 50% is the proportion of university professors that have been permanently lost over the last two decades to the brain drain or to obsolescence. In addition to the brain drain, and possibly more damaging, is internal brain waste. Indeed, a significant number of skilled scientists, technicians and engineers, defaulted from the public sector joined the private sector or started their own business. While this may seem as necessary labor mobility and forms of diffusion of valuable accumulated know how, a significant amount of skills and experience is lost in the process. Many of these technicians and engineers invest in low-grade services [restaurants, shop keeping, taxis etc.]. Internal brain waste takes also the form of technical and scientific personnel involved in administrative and office positions or in pluri-activity as a result of low and insufficient wages paid. University professors in large MENA countries are often involved in several activities, making the undertaking of research work impossible. The latter issue is particularly harming the innovation in Health biotech. Several attempts have been made by some MENA countries to encourage scientists to return home or to reverse the brain drain (brain gain), but very limited results were obtained. This is mainly because of the fact that most of the reasons that provoked the brain drain to begin with are still valid. Short of reversing physically the brain drain, MENA countries are trying to set up a comprehensive systematical and coherent plan to benefit from their Diasporas living abroad. Various channels are being used to involve a maximum of such manpower in the R&D capacity building, efforts such as repeated invitation to lecturing, collaboration in specific research programs and consulting. In Syria, an NGO called Nosstia attempts to bring Syrian innovators back to Syria for short-term involvement.

4.5 - Ethical and societal issues

A wide variety of ethical and social issues are associated with biotechnology research, product development and commercialisation. In MENA, particularly, these issues are sensitive. Indeed, most if not all of the MENA countries belong to the Muslim world. In most of MENAs societies, the cleric authorities usually have a saying on how the novel technologies shall be considered with regard to Islamic beliefs. Dictates often emanate after formal consultation of the official clerical authorities at the regional level. The decision makers usually try to take into consideration their suggestions and comments on technological issues. MENA clerical authorities have met in Qatar in the mid nineties to debate health biotech issues such as cloning, gene therapy and genetic determination. They concluded that any technical progress that help a diseased human being getting as close as possible to the normal healthy status while being of no harm to other human being, should be allowed. However public adhesion to dictates from official clerical authorities 22

may vary according to the interpretation of the religious subgroups that are flourishing in the region. 4.5.1. Gene therapy: Gene therapy should be subject to greater oversight than virtually all other therapeutic technologies. A system of oversight for gene therapy is strongly recommended. This system needs to be set up by the health authorities to allow gathering the collection of data safely, while ensuring patient confidentiality and protection of trade secrets that protects patients without hurting the integrity of the product development process. The field of gene therapy continues to focus on patients with severe and life-threatening diseases who usually have few treatment options or who have failed all available therapies. However no gene therapy trial has been performed to date in MENA. 4.5.2. Medical privacy and genetic discrimination: In most MENA countries, scientific communities recognize the need for confidentiality of all individually identifiable medical information. However, we have no knowledge of any national policy, legislation or regulations that are effectively implemented to protect the confidentiality of all personal medical information, including data derived from genetic tests. There is an urgent need for regional legislation on how individual medical information should be respected, treated confidentially and safeguarded from discriminatory misuse. This protection must be balanced, however, with the need to continue valuable medical research into new diagnostic tests, therapies and cures. 4.5.3. Cloning: While human reproductive cloning, using cloning technology to create a human being will be by all means opposed by the MENA region, the application of cloning technology referred to as therapeutic cloning, or somatic cell nuclear transfer (SCNT) would fit the dictate of the clerical communities mentioned above that emanated from the Qatar MENA clerical summit. However, clear legislation on these specific issues and many others is urgently needed. Cultural impact on technological change and innovation has often been overlooked or given low consideration. At best, it was looked at as a temporary problem of adaptation by the local operatives and users soon to be overcome. However, it is a far more fundamental and complex issue. Culture can be a source of creativity and innovation27. The cultural factor could be used as a guide, a source of information, a set of psychological and relational assets to be mobilized. Consequently, a clear idea of the local cultural specificities and their assessment could constitute a first step to harness this
27

Amar, A. : Des spcificits culturelles comme sources dinnovation technologique in A. Djelfat, R. Zghal &M. Abbou LInnovation au Maghreb :Enjeux et perspectives Ed. Ibn Khaldoun, Oran, 2000, pp291-316

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potential of a culture-based innovative process. From an economic point of view, culture could be beyond simply a tool of adjusting and adapting an economic offer to a demand to target market segments. Tradition can constitute specific technological packages and innovative ventures. Policymakers have rarely emphasized this positive view of culture. In MENA, when this issue is raised, it is often in official declarations and documents and remains purely theoretical. It is more linked to restoration of identity and culture and is seldom preoccupied with its economic significance and more precisely its relationship to knowledge, science, creativity and innovation. In this vacuum, most cultural factors appear as obstacles and impediments to modernization and access to advanced technologies. Cultural issues relate to the language used, to the role and importance of traditions, values and religion, to the impact of oral culture as well as inherited practices from colonial times mainly in the Maghreb countries. The Arabic language is the first spoken language in most of MENA countries. Communication in the field of science and technology remain difficult in the poorly managed arabization of teaching (The educational system becoming a poor bilingual mix) and administrative life of these countries. This is the consequence of an obvious lack of clear orientation and weak decision-making processes. This situation raises the more fundamental issue of the Arabic language as having sufficiently evolved to be an adequate vehicle for modern and advanced science & technology and an efficient tool for innovation. 4.5.4. Local traditions and values: As far as local traditions and values are concerned, most of the observers and analysts consider that in MENA and in the absence of policy orientation, they constitute obstacles to science and innovation accumulation. Furthermore, religion, namely Islam, when not properly explored and analysed, can also be seen as an obstacle to innovation. Limited studies were made that tackle the way the sacred book, the Holy Koran, and its precepts can be misinterpreted to constitute an obstacle to innovation and how it can promote science, technology and innovation. Furthermore, the oral culture, which is predominant in MENA, seems to antagonize with codification, reporting, sorting and diffusion of knowledge on a large scale. It does not encourage sustainability as much as diffusion and rests simply on the awareness of the need to register ones experience. These practices still prevail and affect negatively a sector that needs a high level of formality such as the health biotech. In MENA countries, there is an urgent need to develop the culture of quality without which no development of health biotech can be foreseen. This situation is coupled with a strong patriarchal attitude within the R&D institutions, the importance of the rent seeking mentality and the culture of bureaucracy make the cultural environment in MENA not a favourable one for initiators, inventors and entrepreneurs as well as decision makers to put their ideas and energy into effect (women are also not encouraged to participate). Those negative aspects of the local culture may be obstacles to modernity and to a smooth transition to a KBE. However, if these societal issues are properly understood and tackled the right way, it

24

would represent a real asset for creating not only a knowledge society but also an innovation society.

4.6- Public perception of Biotech

The issue of general public awareness of the impact that health-related biotechnologies have on peoples lives, has so far been neglected in MENA. Indeed, despite the efforts in education and the good rates of literacy throughout the region, the level of perception by the general population of how these technologies can affect individuals and society as a whole remains low. This issue is directly related to the level and quality of the information that is being provided about this issue in the region. To illustrate the importance of public awareness and the need for appropriate information, we can relate two experiences that have been conducted at the scale of the Tunisian population. The first one28 consisted of conducting a large and comprehensive psychosocial survey to assess the level of perception by the general population of the concept of genetic diseases and to estimate the odds of success of a program aimed at reducing the incidence of genetic diseases based on prenatal diagnosis and preventive abortion. This study yielded several interesting observations. The level of awareness was proportional to the level of information and the way this information was provided. It was clear that peoples who were directly or indirectly concerned by this type of diseases were well informed [through close contact with doctors and genetic councillors] and had the right perception of this issue. The odds of success of prevention based on genetic testing and eventual abortion were very high in this group of people. While the group of people who had no direct contact with these diseases but still might be concerned by this issue, showed a near complete absence of awareness and total lack of information on how to deal with this issue. Interestingly, this study also showed that information based on written or printed material was ineffective as compared to the high impact of audiovisual means, especially television. This observation showed that the oral culture indeed still prevails strongly in the MENA region. The second experience [D. Fathallah; unpublished data] which is still running in Tunisia, consisted of developing locally the DNA-based paternity testing or DNA fingerprinting technology in the early nineties. The use of this technological advance was empowered in 1998 by a legislation stipulating that nobody can be born of unknown parents and that paternity dispute should be settled in court on the basis of DNA testing. This strategy benefited from a large audiovisual information campaign that had a large echo in the population. As a result, a large number of children and even adults were attributed to their legitimate father and given a family name, which is a highly important status symbol in MENA. Furthermore, this technology in being used for forensic purposes and is helping in delivering scientific evidence to courts in criminal cases.
28

D. Fathallah: A comprehensive study to assess the impactof genetically transmitted diseases on the Tunisian population. EU Avicenne Program Report, 1996, Brussels, Belgium

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These examples show how awareness and proper information can make a difference with regard to the development of health biotech. Specific advances in this field are creating new needs, namely the need for genetic counselling and trained genetic councillors and strong public awareness campaigns.

4.7- Challenges
The MENA countries have faced the challenge of putting forward policies and strategies that should have given at least some encouraging results to open the path of development. Instead, a generalized insufficiency of those policies is being observed. Understanding the exact causes underlying such generalized failures will be crucial to correct mistakes and get the system back on the right track of modernization and development. The main challenge that faces all MENAs countries will be to move into a knowledge-based economy rooted in an efficient system of innovation. To succeed in this endeavor, all of the issues raised above will need to be properly tackled. An efficient system of innovation at the national and /or the regional level will need to be built. At the governance level, appropriate measures need to be taken to make effective the implementation of the policies and strategies set earlier. Raising the level of awareness and developing an efficient information system will also be among the challenges that need to be faced. Most of the MENA countries are trying to reach the threshold of 1% of GNP to be dedicated to research and innovation. However, it would probably be a difficult task to reverse the financing issue, given the limited resources of most of countries. However, a better focus on local problems and relevant sectors, combined with a better use of existing human resources, will probably pave the way to success. Last but not least, the societal issues should be taken very seriously and oriented into their positive aspect to meet the objective of development and better health care for all. It should, however, be understood that when it comes to get the social fabric of MENA countries to follow the road of progress with regard to social and societal aspects, a framework of creativity across the board for all aspects of life needs to be set up, a formidable task that has to be undertaken anyway. Sorry, this is vague. How intervention of organization such as IDRC can help in facing these challenges is an interesting question that is addressed to the conferees.

5.

Foresight as a tool to shape the future of health biotech in MENA.

Forecasting, technology assessments, future studies and other forms of foresight, trying to identify long term trends need to guide decision-making from now on. Foresight that emerged in recent years mostly in Europe aims at identifying todays research and innovation priorities on the basis of scenarios of future developments in science and technology, including biotechnologies in strategic sectors such as agriculture and health.

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Foresight is a participative process involving different stakeholders. The latter may include public authorities, industry, research organizations, nongovernmental organizations, and the communities themselves. Foresight aims at identifying possible futures, imagining desirable futures and defining strategies to shape this future. Results are generally fed into public decisionmaking (for example, which research priorities deserve public funding), but they also help participants themselves to develop or adjust their strategy. Thinking, debating and shaping the future is even more essential in MENA today because of the complexity of science, technology and society interrelationships. The limitation of financial resources, the increasing rates of scientific and technological change impose on governments and the actors in the research and innovation system to make choices. A foresight study in science and technology that included health biotechnology has been recently conducted by the Tunisian Institute for Strategic Studies (ITES) to define the strategy that needs to be adopted to help the country reaching a Knowledge-Based-Economy in the horizon of the year 2030 29. In line with these activities, Egyptian health authorities in collaboration with staff from the CDCs national center for health statistics are carrying out a project known as Healthy Egyptians for the horizon 2010 5. This program is aimed to establish health objectives for the nation and both baseline and data collection to track progress towards reaching those aims. If a foresight study is to be carried out in MENA, the process can be organized at different levels: cross-national, national or regional. Open discussion between stakeholders is encouraged. Interaction in a Panel format has proven to be very efficient for this type of desired outcome.

Role of IDRC in promoting biotech in MENA

(To be finalized after the workshop) The issues raised above represent many fields of intervention for IDRC to help the MENA region to integrate biotech in its development efforts. To assess the overall situation of biotech in the region, and get a clear vision on how the future of biotech in MENA could be in year 2025, IDRC could promote and lead a foresight study at the regional level, involving local and foreign foresight specialists. The results of such a study will complete the outcome of the current workshop and would not only be useful to IDRC in identifying more accurately its own priorities and niche area for intervention, but would also benefit decision makers in improving policies and strategies. IDRC involvement can also be at different levels. At the macro level, the issue of building a system of innovation is a matter of national or regional policy

29

D. Fathallah: The Tunisian foresight experience in S&T. The 4th EU/e Foresee International Conference. Malta November 2003

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[making and depends on the system of governance. However IDRC could contribute to promoting the innovation culture in the region by working in collaboration with local and/regional organizations and institutions such as ALECSO, universities, research institutions and relevant associations to develop a research activity aimed at answering the following set of questions: How to assess the shortfall of the policies followed by the MENA countries to develop biotech? What are the real obstacles to the development of the culture of innovation In MENA? What economical, political, social approach should MENA adopt to reach equitable access to biotech products and services throughout the region and within social groups in a given country? What is the impact of local culture on the innovation process? How would the local culture be used to promote innovation? Is the Arabic language a barrier of entry to a knowledge-based Economy? How to improve the participation of human resources from the diaspora in the biotech development effort? How to strengthen IP protection in the region? Define the needs for legislation to implement medical privacy and prevent social discrimination? How to improve public awareness of the impact of biotech on individuals and societies?

Specific and immediate actions which could be undertaken by IDRC includes: 1- Tackle the issue of genetic diseases that are highly frequent in the region and are among the most elevated in the world, mainly because of the high level of consanguineous marriages throughout the region, IDRC can : Extend to the rest of the MENA region, the Tunisian experience of assessing the psycho-social perception of genetic diseases and evaluate the success of prevention programs based on DNA prenatal testing and Contribute in capacity building in genetic counseling, by developing channels and providing tools [grants and fellowships] through which a number of genetic counselors can receive high training.

2- To develop public awareness of the biotech issues and to help scientists in the region keep up with biotechnologies advances, The Center could promote information to these two types of public. For the general public, IDRC can contribute in providing specific information on the real possibilities that biotech can offer in health care as well as the issues that it raises. The public debate on biotechnology is rather missing in the MENA countries and improving the level of information will help triggering such social activity.

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For scientists, IDRC could facilitate the access to specialized scientific literature, especially to relevant data banks via the WEB. It is expected that the workshop will provide a more exhaustive view on the role of IDRC in helping MENA developing its biotech.

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CONCLUSION
Development of health biotech in the MENA region seems to be falling short of the regions needs, despite the efforts that have been made in the last two decades by most countries in the region. We have addressed some of the issues and challenges that might be relevant to the development of health biotech in the region. Whether these issues have been tackled properly at the different levels of the development process is a matter of debate. However, at the governance level and as far as policies and strategies planning are concerned, significant efforts have been made, but suffer from a lack of implementation. This result has not sufficiently been analyzed, especially with regard to societal issues, which may be a major obstacle. This can benefit from appropriate research that would investigate the link between the lack of implementation of national policies and the many social, cultural and economic issues in MENA such as the heavy reliance of oral tradition. The limited involvement of the private sector in this effort is probably due to the limited financial resources of most of the MENA countries as well as a lack of awareness of the economic opportunities that this field may provide. The issue of human resources that is especially crucial for the development of this type of activity have not been anticipated and relied very much on the education system that was not oriented toward specific needs. Efforts are still required to involve the general public in the biotechnology debate. An appropriate information system will have to be included among the programs of biotech development. Other issues relevant to biotech development in MENA are still to be uncovered and the consultation that IDRC is undertaking will probably be of good help in this respect.

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