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MERO

Regional Workshop on Biotechnology in the Middle Eastand North Africa

Sept 29-30, 2004Cairo, Egypt

Background Paper: Health Biotechnology in MENA

By Professor Dahmani M. FathallahInstitut Pasteur de Tunis

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


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

Abstract 2

Introduction 31. Introduction to health biotechnology 4

1.1. Defining biotechnology 41.2. Overview of health biotechnology 5

1.2.1. Novel biotechnologies 51.2.2. Health care application 51.2.3. Status of health biotechnologies in MENA 8

2. MENA populations characteristics 103. Current health status and biotechnology in the region 11

3.1.Epidemiological trends 11

3.2. MENA needs for Biotech Products 124. Health biotech in MENA: Main issues and challenges 13

4.1. Health Biotech and the national system of innovation 134.1.1. Manifestations of the shortfall

of effective innovation systems 144.2. Policy and strategy planning 15

4.2.1. New Institutions and bodies 164.2.2. Regulatory framework 164.2.3. Strategic planning and priorities setting 164.2.4. Mobilization of human resources 174.2.5. New incentives schemes 17

4.3. Financing of the innovation effort in MENA 184.4. Human resources 20

4.4.1. Brain drain and brain waste 214.5. Ethical and societal issues 22

4.5.1. Gene Therapy 224.5.2. Medical privacy and genetic discrimination 224.5.3. Cloning 224.5.4. Local traditions and values 23

4.6. Public perception of biotech 244.7. Challenges 25

5. Foresight as a tool to shape the future of health biotech in MENA 266. Role of IDRC in promoting biotech in MENA 27Conclusion 29

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ABSTRACT:

Integrating modern biotechnology in their efforts to achieve national and regionaldevelopment is a big challenge facing all MENA countries. As part of its efforts toexplore how the International Development Research Centre (IDRC) could help the

region overcome this challenge, IDRC is launching a regional consultation onbiotechnology with emphasis on health and agriculture biotechnology. The overallaim of this consultation is to investigate how the Centre can contribute effectively tostrengthening the regions biotech capacity. Toward these ends, IDRC is organizing aworkshop 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 theconferees 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 consideredin the debate. Then it gives an overview of health biotechnology and presents the newtechnologies 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 themajor 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 thedevelopment of biotech in MENA. The issues raised in this paper include, at thegovernance level, the issue of the link between biotech development and the nationalsystem of innovation and the nature of the policy and strategies taken to favor biotechdevelopment. The issues of financing innovation and human resources that fuel

biotech development are also discussed. The societal and ethical issues that biotechraises 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 playin promoting biotech in the region, as well as suggestions for some specific immediateactions.

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INTRODUCTION

In the dawn of the third millennium, opposing pessimistic and optimisticvisionsof 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 seemsinconceivable not to integrate modern biotechnologies in the development of amodern agriculture or health system. Nobody can imagine what would have been theconsequences of ignoring electricity, air transportation, telephone or any othertechnologies of the last century. The developed world has already entered the biotechera 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 andparticularly in Health biotech? What are the major currents and future needs? Whatare 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 manyquestions that IDRC is trying to answer as part of its commitment to help humandevelopment in this part of the world.Toward these ends, IDRC has taken the initiative to invite different stakeholders inthe field of biotech from most of the MENA countries and organize a workshop todebate of health and agriculture biotechnology.The following paper is meant to give some working material for the conferees andcontribute to launching a constructive debate that would hopefully lead to bringingout all of the relevant issues in the health biotech field in MENA. Another expectedoutcome 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 modernbiotechnology followed by an overview of the novel life science technologies thatconstitute 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 betterintroduce 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 thedevelopment of health biotech. These issues are discussed in the context of thedifferent MENA countries experiences to help IDRC identify the most relevant

biotech developments in the region, set up priorities and define intervention nichesand research approaches. The challenges that face MENA countries for thedevelopment of health biotech are also listed. To conclude the paper, the foresightexperience in the field of biotech of some of the MENA countries is reported. Theutility 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: HumanImmunodeficiency Virus IDRC: International Development Research Centre . KBE: Knowledge Based

Economy. MENA: Middle East and North Africa. MSc: Master in Sciences. NSI: National System ofInnovation. PhD: Philosophical High Degree. R&D: Research and Development. RNA: Ribo NucleicAcid. S&T: Science and technology. WHO: World Health Organization

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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 humansociety 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 commercialapplication of living organisms or their products, which involves the deliberate

manipulation of their DNA molecules" This definition implies a set of laboratorytechniques developed within the last 20 years that have been responsible for thetremendous scientific and commercial interest in biotechnology 1, the founding ofmany new companies, and the redirection of research efforts and financial resourcesamong established companies and universities. These laboratory techniques providescientists with a spectacular vision of the design and function of living organisms, and

provide technologists in many fields with the tools to implement exciting commercialapplications.

Why is biotechnology suddenly receiving so much attention?

This is mainly due to the unlimited applications that the technological advances areallowing. Indeed, it became possible to use the smallest parts of organisms-their cellsand biological molecules-in addition to using whole organisms to make new productsand 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 wordbiotechnology would be to simply consider its plural form, biotechnologies instead ofthe singular noun, biotechnology.

Hence, biotechnology can be defined more accurately as a collection oftechnologies that capitalize on the attributes of cells, such as their manufacturingcapabilities, and put biological molecules, such as DNA and proteins, to work for

us.

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

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1.2. Overview of health biotechnology

1.2.1 Novel biotechnologies

In line with the most exhaustive definition of biotechnology, we herein present alisting of the technologies, which in the beginning of the third millennium areintroducing a revolution in the health system as a whole. These technologies 1 willaffect the MENA region like any other part of the world not only in the way howhealth care will be provided but also the productive sector and even with regard to thesocial, 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 manufacturingmachinery to produce desired products.

Cellular Technology: It consists of culturing cells outside of a livingorganism: in vitro. Mammalian cells and insect as well as hybridoma cultures,for the making of monoclonal antibodies, are the most developed. Cellulartechnology has also allowed cellular and animal cloning.

Recombinant DNA Technology: It allows molecular cloning, mainly genecloning, as well as the manipulation of DNA sequence.

Protein Engineering: It uses DNA cloning and genetic engineering incombination 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 thosein molecular biology.

Microarrays: Microarray technology is transforming laboratory researchbecause it allows us to analyse tens of thousands of samples simultaneously. Itincludes 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 significantprogress at different levels ranging from major discoveries in basic life sciencesresearch to discovery of new state of the arts products that are revolutionizing the wayhealth care is provided [Products tailored to individuals, novel more potent and safervaccines, novel more accurate and cheaper diagnostic tools]. These technologicaladvances are also leading to novel therapeutic approaches. In human health care,

biotechnology products include quicker and more accurate diagnostic tests, therapieswith fewer side effects and new and safer vaccines. The following briefly outlinesome biotech applications in the field of health:

A- Diagnostics:

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We now use biotechnology-based tests to diagnose certain cancers, such as prostateand ovarian cancer, by taking a blood sample, eliminating the need for invasive andcostly surgery. In addition to diagnostics that are cheaper, more accurate and quickerthan previous tests, biotechnology is allowing us to diagnose diseases earlier in thedisease process, which greatly improves a patient's prognosis. Proteomics researchers

are discovering molecular markers that indicate incipient diseases before visible cellchanges or disease symptoms appear. The wealth of genomics information madeavailable by the Human Genome Project will greatly assist doctors in early diagnosisof hereditary diseases that previously were detectable only after clinical symptomsappeared. Genetic tests will also identify patients with a propensity to diseases, suchas 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 aswell as treatments that would not be possible without these new techniques.Biotechnology therapeutics is used to treat most if not all diseases. The therapiesdiscussed below share a common foundation. All are derived from biologicalsubstances and processes designed by nature. Some use the human body's own toolsfor fighting infections and correcting problems. Others are natural products of plantsand 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 nowmakes feasible.

Using natural products as therapeutics: Many living organisms producecompounds that coincidentally have therapeutic value for us. RecombinantDNA technology and cellular cloning now provide us with new ways to tapinto natural diversity. The ocean presents a particularly rich habitat for

potential new medicines. Marine biotechnologists have discovered organismscontaining compounds that could heal wounds, destroy tumours, preventinflammation, relieve pain and kill microorganisms.

Using biopolymers as medical devices: Biopolymers are biologicalmolecules that can serve as useful medical devices or provide novel methods

for drug delivery. Because they are more compatible with our tissues and ourbodies absorb them when their job is done, they are superior to most man-made medical devices or delivery mechanisms. For example, hyaluronate, acarbohydrate produced by a number of organisms, is an elastic, water-soluble

bio molecule that is being used to prevent post surgical scarring in cataractsurgery, alleviate pain and improve joint mobility in patients withosteoarthritis and inhibit adherence of platelets and cells to medical devices,such as stunts and catheters.

Replacing missing proteins: Some diseases are caused when defective genesdon't produce the proteins (or enough of the proteins) the body requires. It isnow possible to use recombinant DNA and cell culture to produce the missing

proteins.

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Using genes to treat diseases: Gene therapy is a promising technology thatuses genes or genes related molecules such as RNA, to treat diseases. Forexample, rather than giving daily injections of missing proteins, physicianscould supply the patient's body with an accurate instruction manual i.e. a nondefective gene, correcting the genetic defect so the body itself makes the

proteins. Other genetic diseases could be treated by using small pieces of RNAto block mutated genes. Medical researchers have also discovered that genetherapy can treat diseases other than hereditary genetic disorders. They haveused briefly introduced genes, ortransient gene therapy, as therapeutics for avariety of cancers, autoimmune disease, chronic heart failure, disorders of thenervous system and AIDS.

Cell transplants: Approximately 10 people die each day waiting for organs tobecome available for transplantation. To circumvent this problem, scientistsare investigating how to use cell culture to increase the number of patientswho might benefit from one organ donor. Liver cells grown in culture andimplanted into patients kept them alive until a liver became available. Otherconditions that could potentially be treated with cell transplants are type 1diabetes, heart infarction, cirrhosis, epilepsy and Parkinson's disease.

Tissue engineering: Tissue engineering combines advances in cell biologyand materials science, allowing us to create semi-synthetic tissues and organsin the lab. These tissues consist of biocompatible scaffolding material, whicheventually degrades and is absorbed, plus living cells grown using cell culturetechniques.

Stem cells: Stem cell research represents the leading edge of science, abiotechnology method that uses cell culture techniques to grow and maintainstable cell lines. Stem cells are cells that have not yet differentiated. By

starting with undifferentiated adult and embryonic stem cells, scientists maybe able to grow cells to replace tissue damaged from heart disease, spinal cordinjuries and burns, and to treat diseases such as Parkinson's Disease, diabetesand Alzheimer's Disease by replacing malfunctioning cells with newlydifferentiated healthy cells. This process of culturing a line of geneticallyidentical cells to replace defective cells in the body is sometimes referred to astherapeutic 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 genitalherpes.

Biotechnology vaccine production: Most of the new vaccines consist only ofthe antigen, not the actual microbe. The actual biotech vaccine is made byinserting the gene that produces the antigen into a manufacturing cell, such asyeast. During the manufacturing process, each yeast cell makes a perfect copyof itself and the antigen gene. The antigen is later purified. By isolatingantigens and producing them in the laboratory. This method also increases theamount of vaccine that can be manufactured because biotechnology vaccinescan be made without using live animals. Using these techniques of

biotechnology, scientists have developed antigen-only vaccines against life-threatening diseases such as hepatitis B and meningitis.

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DNA vaccine: Recently researchers have discovered that injecting smallpieces of DNA from microbes is sufficient for triggering antibody production.SuchDNA vaccines could provide immunization against microbes for whichwe currently have no vaccines. DNA vaccines against HIV, malaria and theinfluenza virus are currently in clinical trials.

Biotechnology is also broadening the vaccine concept beyond protection againstinfectious organisms. Various researchers are developing vaccines againstdiseases such as diabetes, chronic inflammatory disease, Alzheimer's disease andcancers.

D- DNA Fingerprinting:

DNA fingerprinting, which is also known as DNA typing, is a DNA-basedidentification system that relies on genetic differences among individuals ororganisms. Every living organism (except identical twins) is genetically unique. DNAtyping techniques focus on the smallest possible genetic differences that can occur. Itis used for any task where minute differences in DNA matter, such as determining thecompatibility of tissue types in organ transplants, detecting the presence of a specificmicroorganism, establishing paternity and identifying individual remains.

Paternity testing: Paternity determination is possible with DNA typingbecause half of the father's DNA is contained in the child's genetic material.Using restriction analysis, DNA fingerprints of the mother, child and allegedfather are compared. The DNA fragments from the mother that match thechild's are ignored in the analysis. To establish paternity, the remaining DNA

fragments in the child's DNA fingerprint, which have been inherited from thebiological father, are then compared to the DNA sequences of the allegedfather.

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 othersectors including agriculture, environment and other industrial fields. As far as thehealth 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 economicoutcome, no biotech activity whether emanating from a proper innovation system orthrough effective transfer of technology 2 has been significantly developed in any ofthe 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 almostexclusively on importation. As a consequence, access of the MENA populations tosuch technologies and their derived products [new biotech-derived drugs andvaccines, diagnostic kits and novel therapeutical procedures] for health care, isuneven and varies from country to another according to the financial resources ofeach country. Furthermore, access to biotech-derived products and health services

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

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varies according to the economic level of the different social groups within eachcountry (poor versus rich).

Some of the MENA countries are classified as being dynamic users of thesetechnologies, which implies that a certain level of awareness on the importance of

such technological progress has been reached. This may prepare those countries toenter the next phase of being producers of such technical advances in health

biotechnology. Tunisia, for instance, has integrated some DNA testing technologiesparticularly in forensic and paternity determination use. Algeria, Egypt and Jordanhave acquired some recombinant vaccine manufacturing technologies. At theacademic level these new technologies are being taught in most of the learninginstitutions throughout the region and some R&D institutions are initiating research

programs to develop health biotech related to local health problems such as theBilharzias 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 solvingmany of the region health care and other related problems that emanate directly from

poverty and uneven wealth distribution. The crucial issue remains the equitableaccess 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 developmentactivities, (see Figure 1) they are economically out of reach for a vast majority ofsocial 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 andJordan. However, there still a long way to go before the region fully enters the era ofmodern health biotechnology industry.

Furthermore, the world is currently experiencing a shortage in manufacturingcapabilities 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 anenormous market pull and the difficult barriers of entry to such industry due to

capital-intensive investments, high costs of R&D and extremely stringentmanufacturing rules and marketing regulations set up by the international scientific

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community 3. It is getting more and more difficult to find in the global market enoughproducts that meet the demand t for safe use. Hence all of the MENA countries are atrisk 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 early2000, before adequate steps were undertaken to overcome such shortages.

Hence, development of local or regional capacity for the production of biotech-derived pharmaceutical products will definitely lower the cost of such products, whichnecessarily leads to a more horizontal use of such products and breaks the cycle ofdependency on expensive and limited supplies in the international marketFurthermore, national policies are required to ensure equal access to this technologyand its benefits by all segments of Society. It is getting more and more obvious thathealth care will increasingly rely on biotech products and technologies. For MENA, itis risky to keep relying entirely on imported products. The danger of this riskmaterialized 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 theaccompanying 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 regionlives a large variety of ethnic groups with a predominant Neolithic origin. Thediversity has been conserved through traditional inbreeding (high rate ofconsanguineous marriages). The later had impacted the pattern and incidence ofgenetically transmitted diseases in the region. The recent development of

biotechnology in the field of human genome analysis and genetic fingerprinting asdescribed above could benefit the region, considering that future cures will be tailoredto accommodate the genetic background of individuals.

The regions actual annual population growth rate is 2.7 percent as compared to the1.5 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 exceededeven that of Sub-Saharan Africa's 4. In the 1990s, population growth slowed downslightly. In the last decade economic growth was slower than in any region, exceptSub-Saharan Africa and the transition economies of Europe and Central Asia. In2000-2001, 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 $2per day has increased from 21 to 23 percent of the population.

3 - Zahlan, A.B.: The Maghreb, Innovation and Globalisation. 3rd international Conference, Maghtech

98, April 1998, Tunisia4 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 developedworld with the developing world. Oil booms in the region during the 1970s boostedthe region per capita GNP and allowed investment in education, transportation, urbansanitation and other infrastructure that affect poverty and health. At 68, average lifeexpectancy for both sexes, in the region is relatively high. Infant mortality has been

steadily reduced and primary school enrollment has increased although female youthilliteracy remains at 25%.

The region has a fairly well developed infrastructure. Over 85 percent of itspopulation has access to improved sanitation facilities and water sources; and 66percent of its roads are paved. But with only 1,429 cubic meters of freshwaterresources available per capita, the Middle East and North Africa ranks well below theaverage of other regions. The region has also the highest military expenditure in thedeveloping world: 7 percent of GDP, more than double the spending of the nexthighest region, Europe and Central Asia. However these general improvements masksubstantial disparities among countries, sub regions, between the urban and the rural,

ethnic groups and women and men, etc... The region continues to face significantpublic 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 developmentis a shift in the relative contributions of communicable and chronic diseases to

mortality. As populations become more affluent, the so-called diseases of affluencebecome 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 at0.2% to 0.4% in 2003. Systematic surveillance however remains inadequate, makingit very difficult to deduce accurate trends. UNAIDS estimated the number of peoplewho acquired HIV in 2003 was between 43,000 to 67,000, bringing the estimatednumber of people living with AIDS between 470,000 and 730,000. The epidemicclaimed between 35,000 to 50,000 lives in 2003. The most affected country in theregion 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 countriescould 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 andbetter hygiene. Like in other parts of the world, WHO has also worked efficiently inthe region to eradicate poliomyelitis using different kinds of vaccine and eradicationof measles is underway.

5CDCs Global Health Activities in the Middle east and North Africa.http://www.cdc.org6 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 countriesmainly 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 theworld 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 afterthe development of a genetically engineered recombinant vaccine but is unevenlyapplied.Parasitic diseases:The MENA region also suffers from a pattern of parasitic diseases ranging fromLeishmania (most countries) to Bilharzias (Egypt and Sudan) for which no vaccine isavailable 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 geneticallytransmitted diseases to the status of health concerns. This situation is the consequenceof the improvement of the primary health care throughout the region. Genetic diseasesthat are common in the all of the MENA countries were neglected and considered asfatality because they were poorly understood and lacked accurate diagnosis. Thanks tothe 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 communitieswhich is enormous in the majority of the regions countries, the overall recognition ofthe need for more effective drugs and far-reaching diagnostic and prevention effortshas grown in the region

Most of the MENA countries rely heavily on imported vaccine and other neededdrugs for their prevention programs and treatment.

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The epidemiological trends combined with the high population growth, the currentsocio economical situation along with the improvement of educational level are asmany elements in favour, not only of a growing need for biotech products andservices 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 toreach this objective? Meanwhile specific information and education of the general

population especially in remote areas, on the different issues raised by thedevelopment of health biotech and the impact on individual and social groups livesneed 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 thisstrategic gap and to adopt a knowledge-based economy, with health biotech as astrategic choice.The knowledge-Based Economy KBE is defined as an economy where knowledge

(codified and tacit) is created, acquired, transmitted and used more effectively byenterprises, organizations, individuals and communities for greater economic andsocial 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 ofthe 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 toassimilate 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 roleof sciences and technologies in development, was relatively low. Thus the basicingredient 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 scientificresearch, both basic and applied, massive transfer of up to date technologies fromadvanced countries and substantial investments in training locally and abroad.

7

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 toanother but most of them are far remote from the above definition.Countries such as Tunisia, Egypt, Morocco, Jordan and Algeria have made attemptsto build an efficient NSI system8. They tried to integrate some of the necessarycomponents, 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 effortshave so far failed to deliver a health-oriented biotechnology that is capable oftranslating into innovation and technological progress of socio economicalsignificance.

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 scarcityof 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 asspecific sectors are concerned, the situation differs from one country to another. InMorocco for instance, the most active field is the health sector (16 % of all registered

patents). However, these figures translate into an overall insufficiency whencompared 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 theregion countries have looked unfavorably into this issue that in turn affects anefficient NSI because it constitutes a significant incentive for foreign investors totransfer technology and generate maximum spillover effects. Classification accordingto The Intellectual property rights index IPRI 10 that ranges between 0 an 5 andindicates the strength of laws in defending intellectual property rights locally, had atsome time, pinpointed some MENAs countries as being centers of counterfeits.However this ranking never concerned the health biotech industry.

Scientific publications 11: Despitea steady 10% annualrate 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 thirdapproximately from the health field), scientific production remains highly insufficientas compared to countries such as India, Brazil or South Korea. More indicative is theratio of publication to population that does not exceed 20.4 for the Maghreb and 26for 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

8Alcouffe, 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.61-689Lahzami,Ch.: Place et conditions de linnovation technologique dans les pays du maghreb lhorizondu 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.227-24811Mrayati,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 highlyreputable journals. Indeed publications in international journals on S&T journalsremain relatively limited with 0.32% for MENA as compared to 0.96% for LatinAmerica and 2.9%for Asia. According to these statistics, it seems that MENAscientists perform better in chemistry and physics. It should be noted however, that

this situation might not reflect the real propensity to publish scientific findings asmost of the MENAs scientists confess being subjected to discrimination, and sufferfrom barriers of entry to the S&T publication sphere.

Presence in scientific conferences12: In the earlynineties [1990-1994] the presence of scientists from the MENA countries ininternational conferences as reflected by the number of contributed papers (1%) wasvery 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 countrieswill soon face increasing competition, vanishing trade barriers, more stringentintellectual property regimes and deeper concern for the environment. Trends in allthese areas are expected to pose serious challenges for fragile components in thesocio-economic systems of the region, such as health. Policy-makers will have to

seriously address these challenges. While policies and strategies developed for theclassical health system to face the sanitary situation have been satisfactory in most ofthe 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 becauseof the fact that health biotech development is dependant primarily on the developmentof S&T as a whole13.While most MENA countries are now stressing the need for innovation andtechnological progress, not all of them are clear as to what strategies should beadopted to reach this goal and enter the knowledge economy era and acquire asignificant competitive edge. The situation is however different from one country toanother. For latecomers to biotechnology like MENA countries, the experience of

newly industrialized countries, where governments played a key role, appears to bemore relevant to MENAs present situation. The risk of state intervention should,however, be weighed against the risk of passivity. While the role of governmentsappears paramount, it is also becoming clear that public-private collaboration remainsan important pre-requisite for latecomers to have a chance to compete in the newtechnology-based competitive markets including the huge market of health biotech.Successful policies have taken measures that include 14:

New institutions and bodies.

12The British Library 1994 Index of conference Proceedings13Cooper, 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 specializedinstitutions, 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 observedto date.

4.2.2. Regulatory frameworks:

Setting up of the these new institutions and bodies was concomitant in most of theMENA countries with the promulgation of sets of laws in favor of the development ofS&T with direct links to R&D. In Tunisia, the novel code for investment includes aseries of measures that encourages investment in S&T and defines the venture capitalas a financial tool to invest in innovative projects. According to the 1994 decreerevised 15 in 1996, universities are allowed to contract directly with local or foreigninstitutions for the purpose of undertaking studies, research, consultancy work as wellas 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 academicpersonnel involved (up to 40%). The law promulgated in Algeria 16 in 1998 is geared

specifically towards enhancing capability to innovate, including public enterprise andprivate SMEs. In Egypt, strong patents, trademarks and copyright protection legalsystem 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 plancovering periods of four to five years 17. These plans are aimed at technologicalmastery, research promotion and the strengthening of applied research. Most of theminclude ingredients such as multistage policy for S&T integration into economic

policy, strengthening the links between the private sector and academia and subsidiesfor R&D given to enterprises involved in innovation.Concerning priorities setting, past policies have been characterized by a total lack ofclear 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, pp10215 Law of orientation of scientific research and technological development, decree n94-536 of March10, 1994 and decree n96-6 of January, 1996 and decree n99-11 of January 1999. Official Journal ofTunisia16Loi n98-11, dorientation et de programme a projection quinquennale sur la recherche scientifique et

le dveloppement technologique : Algeria, 1998-200217 Quasim, S. Research and Development in the Arab states: A new commitment Symposia onNTCIs, ESCWA, Beirut, March 2000, p23.

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of biotechnology, regardless of their real needs and potential. Focusing on sectorssuch as agriculture and health seems obvious, and the development of appropriatehuman resources and industrial competitiveness should be oriented towards thesesectors.

4.2.4. Mobilization of human resources:

The issue of mobilization of human resources that was clearly neglected in the past isnow a central preoccupation of policy-makers. The use of foreign technical assistanceis not as systematic as in the past. A new approach is now being adopted to mobilizeand reinforce S&T potential. This is done through Centers of excellence planned inseveral MENA countries notably in the Maghreb: 10 in Morocco, 6 in Algeria and 5in 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 Europeor 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 creatinga variety of incentives. The most common incentive is the R&D specific taxationconcession, which seems to be also the most effective. This support includes varioustaxes exemptions, reduction of custom duties for imported equipments and taxreduction 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, thegovernment has set up the PIRD [prime pour les investissements en R&D], which is agrant 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 asincentives 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 HassanBin Tallal award for scientific excellence, the Hisham Hijjawi prize for appliedSciences, 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 forwardpolicies and strategies to favor innovation, the overall results have fell short wellbelow the minimum level of expectation. This shortage in expected outcome is apreoccupation for all the governments. Preliminary analysis of this shortfall of S&Tpolicies points to failure of policy implementation as being the main reason for thissituation. However, MENA countries need the help of the international community todefine accurately the underlying causes of this failure and to take the necessaryactions to remedy this situation. Organizations such as IDRC could help in this task.

18

La Presse, News paper, October 1998, p.719 Yousri, M.: Initiatives undertaken to promote dissemination, implementation and development ofscience 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 wasnever 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 theimportance of innovation and a policy vacuum characterized by the lack of clearorientation. Despite the efforts made by countries like Algeria, Tunisia & Morocco inthe Maghreb and Egypt, Syria and Jordan in the Mashrek, R&D expenditure as a

percentage of GNP remain insufficient in comparison to developed countries, asshown in the table below.R&D expenditure per inhabitant in MENA countries also compares unfavorably withdeveloping countries. This is in spite of the fact that the economic demand for newtechnology remains relatively important as shown by the deficit in technological

balance of payment (TBP) that reached 10 billion USD in 1995 (more recent figuresare not available).

ND =notdetermined

In all

MENA countries, the budget allocated to R&D is almost entirely spent onwages and salaries of the research personnel. In Morocco, for instance, the

proportion reaches 95%. Furthermore, the governments share of R&Dfunding 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 11others. Public funding remains thus relatively high as compared to countrieslike 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&Dremain relatively weak with only 10% of the total funds coming fromenterprises budget. Nevertheless, the trends show that private funding has been

growing at a higher rate than public funding. However, the lack of venturecapital or risk capital, which is the modern and most adequate type of

Country

Evolution of the average

expenditure ,, , in R&D as a

percentage of GNP between

1994 and 2002

Mauritania 0.26 - ND

Morocco 0.2 to 0.45%

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%

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financing innovation, constitutes a major handicap to development of amodern industry, particularly in the field of health biotech. This situation isthe consequence of the low risk-taking attitude of the private sector in thewhole region. Indeed, several financing groups emerged throughout MENAclaiming the label of venture capitalist. However, a closer look at these

institutions shows that they all function according to the classical bankingsystem, with a very shy or a complete lack of an attitude toward the riskfactor.It should also be mentioned that in the field of health biotech, investing ininnovation is capital intensive, with a long delay in the return on investment ifany.The sharp entrepreneurship crisis observed in the MENA region particularly inthe field of health science is a manifestation of this financing trend. Resortingto foreign financing would be facilitated by necessary domestic financialreforms, 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 codesand reflect the ever-growing need for foreign technology. In all investmentcodes, technology transfer and innovation capabilities as well as theacquisition of state-of-the-art technology and spillovers to local firms areamong the main expectations from foreign investments. Despite the fact thatFDIs have been growing almost exponentially in the whole MENA, the regionstill compares poorly with other parts of the world, namely with South EastAsia: 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 foreigninvestment to developing countries 21. With the limited flows of FDI to theregion, it is difficult to expect tremendous positive effects on technologytransfer in MENA countries. However, even in countries that attracted a greatdeal of foreign investments, the results also do not appear to be satisfactory22.A substantial number of new technologies were introduced in the region overthe 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 tothe ability of foreign investment to built domestic technological andinnovative capabilities is prevailing2. This raises the issue of technologytransfer mechanisms: Can technology be effectively transferred? Are therealternative 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 willgreatly benefit from a clear perception of priority areas and implementation ofappropriate measures geared towards overcoming the weakness of the actualfinancing system.

20Bellon, 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.721Bnassy-Qur, A. et al. : MENA countries in the competition for FDI : Designing an exchange ratestrategy. EU, Paris, 199922

World Bank- IDF project WB 28836 (1997): An Overview of study on improving S&T policyManagement in Egypt

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4.4 - Human resources

The issue of developing human resources has also been the primary concern ofmost of MENAs governments. Large efforts have been made over the last

four or five decades to remedy the situation of shortages of scientificcapabilities by several actions, the most significant one being thereinforcement of training of graduates with the belief that higher educationlevel is central to skills formation and creativity, both necessary ingredientsfor innovation. Most of the countries in the region have been spending a high

percentage of their GNP in education. This policy, however, lackedclairvoyance and planning, and ended up by yielding a large number of highlyeducated and specialized human resources not adapted to the countries specificneeds and hence unable to gear innovation toward innovation and a KBE. Asan illustration of the lack of vision in building an adequate human resourcecapacity: in MENA the number of graduates in natural sciences and

technology remained small, while those in social sciences, art and humanitiesrepresented between 50% to 60% of the total number of graduates of highereducation23. Compared to Europe, the rate of graduates per thousand inMENA is half as much, and yet the number of people involved in R&D is onaverage 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, whileEurope has 1750. There is no significant evidence that higher education helpedto meet development needs through the production of relevant skills and the

provision of R&D support24. Education policy is not matched with economicpolicy, hence the impossibilities for growth reversal30. This situation yielded a

high level of graduate unemployment that is now one of the centralpreoccupations of MENA countries25.Vocational training has long been neglected in most MENA countries 26. Thecase of Egypt is worth mentioning because paradoxically, the increase inqualifications did not necessarily improve the possibilities for the developmentof local capabilities. It rather enhanced the propensity to emigrate.Emigration or brain drain is also the result of another weakness of the humanresources system in MENA, that consists of the low moral and material statusof researchers and their marginalization, as well as their low degree of stabilityand inadequate motivation, poor research conditions and the indigent state ofuniversities.

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.24Lahlou, 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.35-6026Zawdie, 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 tsignificant brain drain. The emigration level of Arab scientific manpower(MSc and PhD levels) has reached levels of the order of 80% in manycountries, to the benefit of industrialized countries mainly. A rough estimation

of 50% is the proportion of university professors that have been permanentlylost over the last two decades to the brain drain or to obsolescence.In addition to the brain drain, and possibly more damaging, is internal brainwaste. Indeed, a significant number of skilled scientists, technicians andengineers, defaulted from the public sector joined the private sector or startedtheir own business. While this may seem as necessary labor mobility andforms of diffusion of valuable accumulated know how, a significant amount ofskills and experience is lost in the process. Many of these technicians andengineers invest in low-grade services [restaurants, shop keeping, taxisetc.]. 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 largeMENA countries are often involved in several activities, making theundertaking of research work impossible. The latter issue is particularlyharming the innovation in Health biotech.Several attempts have been made by some MENA countries to encouragescientists to return home or to reverse the brain drain (brain gain), but verylimited results were obtained. This is mainly because of the fact that most ofthe reasons that provoked the brain drain to begin with are still valid. Short ofreversing physically the brain drain, MENA countries are trying to set up acomprehensive systematical and coherent plan to benefit from their Diasporasliving abroad. Various channels are being used to involve a maximum of suchmanpower in the R&D capacity building, efforts such as repeated invitation tolecturing, collaboration in specific research programs and consulting. In Syria,an NGO called Nosstia attempts to bring Syrian innovators back to Syria forshort-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 clericauthorities usually have a saying on how the novel technologies shall beconsidered with regard to Islamic beliefs. Dictates often emanate after formalconsultation of the official clerical authorities at the regional level. Thedecision makers usually try to take into consideration their suggestions andcomments on technological issues. MENA clerical authorities have met inQatar in the mid nineties to debate health biotech issues such as cloning, genetherapy and genetic determination. They concluded that any technical

progress that help a diseased human being getting as close as possible to thenormal healthy status while being of no harm to other human being, should be

allowed. However public adhesion to dictates from official clerical authorities

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may vary according to the interpretation of the religious subgroups that areflourishing in the region.

4.5.1. Gene therapy:

Gene therapy should be subject to greater oversight than virtually all othertherapeutic technologies. A system of oversight for gene therapy is stronglyrecommended. This system needs to be set up by the health authorities toallow gathering the collection of data safely, while ensuring patientconfidentiality and protection of trade secrets that protects patients withouthurting the integrity of the product development process. The field of genetherapy continues to focus on patients with severe and life-threatening diseaseswho usually have few treatment options or who have failed all availabletherapies. However no gene therapy trial has been performed to date inMENA.

4.5.2. Medical privacy and genetic discrimination:

In most MENA countries, scientific communities recognize the need forconfidentiality of all individually identifiable medical information. However,we have no knowledge of any national policy, legislation or regulations thatare effectively implemented to protect the confidentiality of all personalmedical information, including data derived from genetic tests. There is anurgent need for regional legislation on how individual medical informationshould be respected, treated confidentially and safeguarded fromdiscriminatory misuse. This protection must be balanced, however, with theneed to continue valuable medical research into new diagnostic tests, therapiesand cures.

4.5.3. Cloning:

While human reproductive cloning, using cloning technology to create ahuman being will be by all means opposed by the MENA region, theapplication of cloning technology referred to as therapeutic cloning, orsomatic cell nuclear transfer (SCNT) would fit the dictate of the clericalcommunities mentioned above that emanated from the Qatar MENA clericalsummit. However, clear legislation on these specific issues and many others is

urgently needed.

Cultural impact on technological change and innovation has often beenoverlooked or given low consideration. At best, it was looked at as atemporary problem of adaptation by the local operatives and users soon to beovercome. However, it is a far more fundamental and complex issue. Culturecan be a source of creativity and innovation27. The cultural factor could beused as a guide, a source of information, a set of psychological and relationalassets to be mobilized. Consequently, a clear idea of the local culturalspecificities 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 ofview, culture could be beyond simply a tool of adjusting and adapting aneconomic offer to a demand to target market segments. Tradition canconstitute specific technological packages and innovative ventures. Policy-makers have rarely emphasized this positive view of culture. In MENA, when

this issue is raised, it is often in official declarations and documents andremains purely theoretical. It is more linked to restoration of identity andculture and is seldom preoccupied with its economic significance and more

precisely its relationship to knowledge, science, creativity and innovation. Inthis vacuum, most cultural factors appear as obstacles and impediments tomodernization and access to advanced technologies. Cultural issues relate tothe language used, to the role and importance of traditions, values andreligion, to the impact of oral culture as well as inherited practices fromcolonial times mainly in the Maghreb countries. The Arabic language is thefirst spoken language in most of MENA countries. Communication in the fieldof science and technology remain difficult in the poorly managed arabization

of teaching (The educational system becoming a poor bilingual mix) andadministrative life of these countries. This is the consequence of an obviouslack of clear orientation and weak decision-making processes. This situationraises the more fundamental issue of the Arabic language as havingsufficiently evolved to be an adequate vehicle for modern and advancedscience & 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 andanalysts consider that in MENA and in the absence of policy orientation, theyconstitute obstacles to science and innovation accumulation. Furthermore,religion, namely Islam, when not properly explored and analysed, can also beseen as an obstacle to innovation. Limited studies were made that tackle theway the sacred book, the Holy Koran, and its precepts can be misinterpreted toconstitute an obstacle to innovation and how it can promote science,technology and innovation.

Furthermore, the oral culture, which is predominant in MENA, seems toantagonize with codification, reporting, sorting and diffusion of knowledge ona large scale. It does not encourage sustainability as much as diffusion and

rests simply on the awareness of the need to register ones experience. Thesepractices still prevail and affect negatively a sector that needs a high level offormality such as the health biotech. In MENA countries, there is an urgentneed to develop the culture of quality without which no development of health

biotech can be foreseen. This situation is coupled with a strong patriarchalattitude within the R&D institutions, the importance of the rent seekingmentality and the culture of bureaucracy make the cultural environment inMENA not a favourable one for initiators, inventors and entrepreneurs as wellas decision makers to put their ideas and energy into effect (women are alsonot 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

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

4.6- Public perception of Biotech

The issue of general public awareness of the impact that health-relatedbiotechnologies have on peoples lives, has so far been neglected in MENA.Indeed, despite the efforts in education and the good rates of literacythroughout the region, the level of perception by the general population ofhow these technologies can affect individuals and society as a whole remainslow. This issue is directly related to the level and quality of the informationthat is being provided about this issue in the region. To illustrate theimportance of public awareness and the need for appropriate information, wecan relate two experiences that have been conducted at the scale of theTunisian population.

The first one28 consisted of conducting a large and comprehensive psycho-social survey to assess the level of perception by the general population of theconcept of genetic diseases and to estimate the odds of success of a programaimed at reducing the incidence of genetic diseases based on prenataldiagnosis and preventive abortion. This study yielded several interestingobservations. The level of awareness was proportional to the level ofinformation and the way this information was provided. It was clear that

peoples who were directly or indirectly concerned by this type of diseaseswere well informed [through close contact with doctors and geneticcouncillors] and had the right perception of this issue. The odds of success of

prevention based on genetic testing and eventual abortion were very high inthis group of people. While the group of people who had no direct contactwith these diseases but still might be concerned by this issue, showed a nearcomplete absence of awareness and total lack of information on how to dealwith this issue. Interestingly, this study also showed that information based onwritten or printed material was ineffective as compared to the high impact ofaudiovisual means, especially television. This observation showed that the oralculture indeed still prevails strongly in the MENA region.

The second experience [D. Fathallah; unpublished data] which is still runningin Tunisia, consisted of developing locally the DNA-based paternity testing or

DNA fingerprinting technology in the early nineties. The use of thistechnological advance was empowered in 1998 by a legislation stipulating thatnobody can be born of unknown parents and that paternity dispute should besettled in court on the basis of DNA testing. This strategy benefited from alarge audiovisual information campaign that had a large echo in the

population. As a result, a large number of children and even adults wereattributed to their legitimate father and given a family name, which is a highlyimportant status symbol in MENA. Furthermore, this technology in being usedfor forensic purposes and is helping in delivering scientific evidence to courtsin criminal cases.

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

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

4.7- Challenges

The MENA countries have faced the challenge of putting forward policies andstrategies that should have given at least some encouraging results to open the

path of development. Instead, a generalized insufficiency of those policies isbeing observed. Understanding the exact causes underlying such generalizedfailures will be crucial to correct mistakes and get the system back on the righttrack of modernization and development.

The main challenge that faces all MENAs countries will be to move into aknowledge-based economy rooted in an efficient system of innovation. Tosucceed in this endeavor, all of the issues raised above will need to be properlytackled. An efficient system of innovation at the national and /or the regionallevel will need to be built. At the governance level, appropriate measures needto be taken to make effective the implementation of the policies and strategiesset earlier. Raising the level of awareness and developing an efficientinformation 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 GNPto be dedicated to research and innovation. However, it would probably be adifficult task to reverse the financing issue, given the limited resources of mostof countries. However, a better focus on local problems and relevant sectors,

combined with a better use of existing human resources, will probably pavethe way to success. Last but not least, the societal issues should be taken veryseriously and oriented into their positive aspect to meet the objective ofdevelopment and better health care for all.

It should, however, be understood that when it comes to get the social fabric ofMENA countries to follow the road of progress with regard to social andsocietal aspects, a framework of creativity across the board for all aspects oflife 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 helpin 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 offoresight, trying to identify long term trends need to guide decision-makingfrom now on. Foresight that emerged in recent years mostly in Europe aims atidentifying todays research and innovation priorities on the basis of scenariosof 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 lattermay include public authorities, industry, research organizations, non-governmental organizations, and the communities themselves. Foresight aimsat identifying possible futures, imagining desirable futures and definingstrategies to shape this future. Results are generally fed into public decision-

making (for example, which research priorities deserve public funding), butthey also help participants themselves to develop or adjust their strategy.Thinking, debating and shaping the future is even more essential in MENAtoday because of the complexity of science, technology and societyinterrelationships. The limitation of financial resources, the increasing rates ofscientific and technological change impose on governments and the actors inthe 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 forStrategic Studies (ITES) to define the strategy that needs to be adopted to helpthe country reaching a Knowledge-Based-Economy in the horizon of the year

2030 29.In line with these activities, Egyptian health authorities in collaboration withstaff from the CDCs national center for health statistics are carrying out a

project known as Healthy Egyptians for the horizon 2010 5. This program isaimed to establish health objectives for the nation and both baseline and datacollection to track progress towards reaching those aims.If a foresight study is to be carried out in MENA, the process can be organizedat different levels: cross-national, national or regional. Open discussion

between stakeholders is encouraged. Interaction in a Panel format has provento be very efficient for this type of desired outcome.

6 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 visionon 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 andforeign foresight specialists. The results of such a study will complete theoutcome of the current workshop and would not only be useful to IDRC inidentifying 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 issueof building a system of innovation is a matter of national or regional policy

29D. Fathallah: The Tunisian foresight experience in S&T. The 4 th EU/e Foresee InternationalConference. Malta November 2003

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[making and depends on the system of governance. However IDRC couldcontribute to promoting the innovation culture in the region by working incollaboration with local and/regional organizations and institutions such asALECSO, universities, research institutions and relevant associations todevelop a research activity aimed at answering the following set of questions:

How to assess the shortfall of the policies followed by the MENAcountries to develop biotech?

What are the real obstacles to the development of the culture ofinnovation In MENA?

What economical, political, social approach should MENA adopt toreach equitable access to biotech products and services throughout theregion 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 thediaspora in the biotech development effort?

How to strengthen IP protection in the region?

Define the needs for legislation to implement medical privacy andprevent social discrimination?

How to improve public awareness of the impact of biotech onindividuals 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 areamong the most elevated in the world, mainly because of the high level ofconsanguineous marriages throughout the region, IDRC can :

Extend to the rest of the MENA region, the Tunisian experienceof assessing the psycho-social perception of genetic diseases andevaluate the success of prevention programs based on DNA

prenatal testing and

Contribute in capacity building in genetic counseling, bydeveloping channels and providing tools [grants and fellowships]through which a number of genetic counselors can receive hightraining.

2- To develop public awareness of the biotech issues and to help scientists in theregion keep up with biotechnologies advances, The Center could promote informationto these two types of public.For the general public, IDRC can contribute in providing specific information on thereal 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 andimproving 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 ofIDRC 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 theregions 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 challengesthat might be relevant to the development of health biotech in the region. Whetherthese 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 policiesand strategies planning are concerned, significant efforts have been made, but sufferfrom 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 ofimplementation of national policies and the many social, cultural and economic issuesin 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 mostof the MENA countries as well as a lack of awareness of the economic opportunitiesthat this field may provide. The issue of human resources that is especially crucial forthe development of this type of activity have not been anticipated and relied verymuch on the education system that was not oriented toward specific needs. Effortsare still required to involve the general public in the biotechnology debate. Anappropriate information system will have to be included among the programs of

biotech development. Other issues relevant to biotech development in MENA are stillto be uncovered and the consultation that IDRC is undertaking will probably be ofgood help in this respect.

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