Health Biotechnology in the MENA Region

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					                                  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                                                            2
Introduction                                                        3
1. Introduction to health biotechnology                             4
      1.1. Defining biotechnology                                   4
      1.2. Overview of health biotechnology                         5
             1.2.1. Novel biotechnologies                           5
             1.2.2. Health care application                         5
             1.2.3. Status of health biotechnologies in MENA        8
2. MENA populations’ characteristics                                10
3. Current health status and biotechnology in the region            11
      3.1. Epidemiological trends                                   11
      3.2. MENA needs for Biotech Products                          12
4. Health biotech in MENA: Main issues and challenges               13
      4.1. Health Biotech and the national system of innovation     13
              4.1.1. Manifestations of the shortfall
                              of effective innovation systems        14
      4.2. Policy and strategy planning                              15
              4.2.1. New Institutions and bodies                     16
              4.2.2. Regulatory framework                            16
              4.2.3. Strategic planning and priorities setting       16
              4.2.4. Mobilization of human resources                 17
              4.2.5. New incentives schemes                          17
      4.3. Financing of the innovation effort in MENA                18
      4.4. Human resources                                           20
              4.4.1. Brain drain and brain waste                     21
      4.5. Ethical and societal issues                               22
              4.5.1. Gene Therapy                                    22
              4.5.2. Medical privacy and genetic discrimination      22
              4.5.3. Cloning                                         22
              4.5.4. Local traditions and values                     23
      4.6. Public perception of biotech                              24
      4.7. Challenges                                                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




                                        2
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 region’s biotech capacity. Toward these ends, IDRC is organizing a
workshop aimed specifically at identifying and assessing the region’s 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 MENA’s 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.




                                           3
        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


                                               4
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”.




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


                                                5
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 technologies1 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


                                           6
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 man-
       made 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


                                          7
       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 life-
       threatening diseases such as hepatitis B and meningitis.
      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


                                           8
        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
varies according to the economic level of the different social groups within each
country (poor versus rich).


2
 Djeflat, A.: The management of technology transfer: Views and experiences from developing
countries. International Journal of Technology Management, Vol. 3, N°1/2 pp. 149-166, London 1988.


                                                9
 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 biotech-
derived 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 region’s 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.

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


                                                 11
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
    CDC’s Global Health Activities in the Middle east and North Africa. http://www.cdc.org
6
    WHO report, World health report, 2002, Geneva , Switzerland


                                                   12
 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 region’s 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.


 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.


                                                14
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 MENA’s 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

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 l’innovation technologique dans les pays du maghreb à l’horizon
du XXIe siécle 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 21 st century” ESCWA, Beirut 2000.


                                                  15
publications emanate mostly from universities and are mostly disconnected from the
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 MENA’s 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 world’s 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 MENA’s 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 MENA’s 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.

12
     The British Library 1994 Index of conference Proceedings
13Cooper, 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.



                                                   16
Successful policies have taken measures that include 14:
    New institutions and bodies.
    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 Egypt’s 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.

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 n°94-536 of March
10, 1994 and decree n°96-6 of January, 1996 and decree n°99-11 of January 1999. Official Journal of
Tunisia
16
   Loi n°98-11, d’orientation et de programme a projection quinquennale sur la recherche scientifique
et le développement 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.


                                                 17
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
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
region’s 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


18
  La Presse, News paper, October 1998, p.7
19
  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


                                                18
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.


        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 20,21, 22 ,23 in R&D
                             Country                  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%
                 ND = not determined


20
   Akacha SE.A. Financing of scientific research: Impacts on the Arab scientific institutions. Arab
Journal of Science, n°31, June 1998 pp.35-45
21
   SERST : Tunisian « Secretariat d’Etat à la Recherche Scientifique et Technologie ». 1996 Annual
report
22
   La Presse, News paper, April 2003, p.5
23
   El Watan, News paper, July 14, 2002, p2


                                                 19
         In all 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
         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 24
          [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 25. 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 satisfactory26.
         A substantial number of new technologies were introduced in the region over

24
   Bellon, B.: Les investissements directs étrangers et les politiques de development industriel : Effets
d’eviction ou avantages construes. Reseau EMMA, Commissariat général du Plan, Paris, Mars, 1997,
p.7
25
   Bénassy-Quéré, A. et al. : MENA countries in the competition for FDI : Designing an exchange rate
strategy. EU, Paris, 1999
26
   World Bank- IDF project WB 28836 (1997): An Overview of study on improving S&T policy
Management in Egypt



                                                   20
        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.



                 4.4 - Human resources
        The issue of developing human resources has also been the primary concern of
        most of MENA’s 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
        education27. 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 support28. 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 countries29.


27
   Djelfat, A.: Technologie et système éducatif en Algerie; 3rd International Conférence Maghtech 98,
April 1998, Tunisia.
28
   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.
29
   Lahlou, M.: La problématique de l’emploi et de la pauvreté et le programme d’ajustement structurel
au maroc. Revue CENEAP, n°17, pp.35-60


                                                 21
        Vocational training has long been neglected in most MENA countries30. 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:

         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.




30
 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.



                                             22
       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 MENA’s 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
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


                                  23
        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 innovation31. 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
        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. 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 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.

31
  Amar, A. : Des spécificités culturelles comme sources d’innovation technologique in A. Djelfat, R.
Zghal &M. Abbou « L’Innovation au Maghreb :Enjeux et perspectives »Ed. Ibn Khaldoun, Oran, 2000,
pp291-316


                                                24
        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 one’s 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
        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 people’s 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 one32 consisted of conducting a large and comprehensive psycho-
        social 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

32
  D. Fathallah: A comprehensive study to assess the impactof genetically transmitted diseases on the
Tunisian population. EU Avicenne Program Report, 1996, Brussels, Belgium


                                                 25
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.

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 MENA’s 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


                                   26
             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 today’s 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.
             Foresight is a participative process involving different stakeholders. The latter
             may include public authorities, industry, research organizations, non-
             governmental 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 decision-
             making (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 33.
             In line with these activities, Egyptian health authorities in collaboration with
             staff from the CDC’s 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.




     33
      D. Fathallah: The Tunisian foresight experience in S&T. The 4th EU/e Foresee International
     Conference. Malta November 2003


                                                      27
   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 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
       [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


                                         28
                     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.
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.




                                             29
CONCLUSION
Development of health biotech in the MENA region seems to be falling short of the
region’s 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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