BUILDING THE BIOECONOMY 6TH EDITION

National Biotechnology Industry Development Strategies Globally

SECTION

This report was commissioned by the Biotechnology Industry
Organization. The views represented here are those of the authors only.
Copyright © Pugatch Consilium 2019
The moral right of the authors has been asserted.
All rights reserved. Without limiting the rights under copyrightreserved above, no part of this publication may be reproduced, stored
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2

BUILDING THE BIOECONOMY 6TH EDITIONCONTENTS
LIST OF ABBREVIATIONS

4EXECUTIVE SUMMARY

7

1

13
13
13
13
14
14

INTRODUCTION

1.1	Rising to the challenge – biotechnologies for sustainability
1.2	Objectives of the 2019 edition of Building the Bioeconomy
1.3	Enabling factors for biotech success
1.4	A wider sample of national biotech policies
1.5		Report overview

2

THE STATE OF GLOBAL BIOTECHNOLOGY IN 20192.1	The story of the early 21st century: The rise of China
2.2	The future of global trading relations: Effective market access andthe protection of IP
2.3	One step forward, two steps back…
2.4	Cost control at all costs? Developments in biopharmaceutical pricing policies
2.5	Growing headwinds for IP protection
2.6 A ray of light? NAFTA 2.0

17
17
18
20
20
24
26

3	ZOOMING IN ON THE NEW COUNTRIES SAMPLED IN THE
BUILDING HE BIOECONOMY

29

3.1 Laying the foundation: Algeria, Ecuador, Kenya, Nigeria and the Philippines
3.2	Reaching for biotech excellence: Canada, Lithuania, France, Germany,
Netherlands and Norway

29
32

4	MEASURING POLICY IMPACT AND REAL-WORLD BIOTECHNOLOGYRESULTS – THE BIOTECH POLICY PERFORMANCE MEASURE

37

4.1 Policy inputs
4.2 Biotech outputs
4.3 Green, yellow and red – Traffic light classification system
4.4 The Biotech Policy Performance Measure – Overall results
4.5	The Biotech Policy Performance Measure – Discussion

37
41
44
45
47

5	FINAL THOUGHTS AND RECOMMENDATIONS

49

NOTES

50

TABLES AND FIGURES
Table 1
Table 2
Figure 1
Table 3
Table 4
Figure 2

Seven enabling factors for biotechnology innovation
14
Building the Bioeconomy 2019 44 economies by World Bank income group 15% share of global GDP, current USD, 1990-2017, China and United States
17
Biotech Policy Performance Measure, policy input indicators
38
Biotech Policy Performance Measure, biotech outputs
42
The Biotech Policy Performance Measure – Overall Results
46

3LIST OF ABBREVIATIONSAMNOGPharmaceuticals Market Reorganization Act (Germany)
ASEAN
Association of Southeast Asian Nations
ATU
Temporary Use Authorization (France)
BCI
Biopharmaceutical Competitiveness and Innovation
BERD
Business Expenditure on R&D
CEA
Cost Effectiveness Analysis
CRISPR
Clustered Regularly Interspaced Short Palindromic Repeats
CSP
Certificate of Supplementary Protection
DRA
Drug Regulatory Authority
EC
European Commission
ECJ
European Court of Justice
EMA
European Medical Agency
EU
European Union
FAS
Federal Anti-monopolistic Service (Russia)
FDA
US Food and Drug Administration
FDI
Foreign Direct Investment
GDP
Gross Domestic ProductGE
Genetically Engineered
GM
Genetically Modified
GMO
Genetically Modified Organism
HTA
Health Technology Assessment
ICT
Information and Communications Technology
IPIntellectual Property
IPI
International Pricing Index
IPRsIntellectual Property Rights
IRP
International Reference Pricing
KORUS
Korea-US Trade Agreement
MoH
Ministry of Health
NAFDAC	National Agency for Food and Drug Administration
and Control (Nigeria)
NAFTA
North Atlantic Free Trade AreaNDA
New Drug Authorization

4

BUILDING THE BIOECONOMY 6TH EDITION

LIST OF ABBREVIATIONS (cont.)
NME
OECD
P&R
PhRMA
PMP
PPP
PRO
PTE
RDP
R&D
SDGs
SMEs
SPC
STI
TCC
USMCA
VC
WHO
WIPO
WTO

New Molecular Entity
Organization for Economic Co-operation and Development
Pricing and Reimbursement
Pharmaceutical Research and Manufacturers of America
Price Maintenance Premium
Purchase Power Parity
Public Research Organization
Patent Term of Extension
Regulatory Data Protection
Research and Development
Sustainable Development Goals
Small and Medium Enterprises
Supplementary Patent Certificate
Science, Technology and Innovation
Therapeutic Class Comparison
US-Mexico-Canada Agreement
Venture Capital
World Health Organization
World Intellectual Property Organization
World Trade Organization

5

6

BUILDING THE BIOECONOMY 6TH EDITIONEXECUTIVE SUMMARY
2019 marks the sixth edition of the Building the Bioeconomy series. Since 2013it has taken the pulse of biotechnology policy frameworks by looking at theirdevelopments and overall performance in some of the major economies aroundthe world. The overriding goal of this exercise has been to identify how successful
biotechnology sectors can be built and sustained.
Seven enabling factors for biotech success
The analysis and policy mapping of Building the
Bioeconomy is built around seven enabling factors
for biotechnology development. The factors
range from the institutional and eco-system level(such as levels of tertiary education, technical skill
and IP environment) to the more biotech specific(such as what type of biomedical and biotech
R&D infrastructure does a country have in place

and availability of technology transfer laws andmechanisms). Together these factors create theconditions that give countries and policymakers
the best chance of having success in developing
their biotech capacity and promoting biotech
innovation.
The below table provides an overview of thesefactors and a brief description of each.

Seven enabling factors for biotechnology innovation
Key enabling factors

Explanation

Human capital

A basic and fundamental building block for the biotech sector is the availability of high skilled andtechnically trained human capital. Without the right human capital it is virtually impossible to create theconditions in which biotech innovation can take place.

Infrastructure for R&D

Combined with having adequate, educated and technically proficient levels of human capital, R&D
infrastructure and capacity is critical to successfully fostering innovation and activity in high tech sectors
including biotechnology. Without the necessary laboratories and clinical research facilities biotechnology
R&D would be next to impossible.

Intellectual property
protection

IPRs (including patents and regulatory data protection) are historically of real importance to the biotech
and biopharmaceutical innovation process. For biopharmaceutical as well as non-pharmaceutical biologicalproducts and technologies the evidence suggests that IPRs incentivize and support the research anddevelopment of new biological technologies and products.

Regulatoryenvironment

The regulatory and clinical environment in a given country or region plays an important role in shaping
incentives for innovation and establishing adequate levels of quality and safety for biotech products,
particularly biopharmaceuticals. A strong regulatory environment creates the conditions for the production
and sale of high-quality products and technologies.

Technology transfer

Technology transfer is a critical mechanism for commercializing and transferring research from public andgovernmental bodies to private entities and private-to-private entities for the purpose of developing usable
and commercially available technologies.

Market andcommercial incentives

Market and commercial incentives range from general R&D incentives to specific policies aimed atbiotech sectors such as pricing and reimbursement policies for biopharmaceuticals. For thebiopharmaceutical sector incentives determined by pricing and reimbursement systems for medicinesand health technologies can have a profound impact on commercial and market incentives for innovationin health and biotech R&D.

Legal certainty(including therule of law)

The general legal environment including as it relates to the rule of law and the rule of law within a business
context is crucial to commercialization and business activities.

7

EXECUTIVE SUMMARY

A wider sample of national biotech policies
This edition of Building the Bioeconomy expands
the analysis by one-third – from 33 to 44 of theworld’s major economies and aspiring biotech
pioneers. The below table lists the 44 countries
included in this year’s report according to WorldBank income level with the 11 new countries
highlighted in bold.

Key findings and Biotech Policy
Performance Measure results
First featured in 2015, the Biotech Policy
Performance Measure (the “Measure”) is anempirical tool that directly compares economies’
policy inputs with real-life biotech outputs. This
year the Measure examines a total of 30 indicatorswith two new indicators having been added tothis edition of Building the Bioeconomy. These
indicators are divided between 18 measures ofpolicy inputs (as in previous editions related tothe seven enabling factors listed above) and 12
indicators of biotechnology outputs. Together
these indicators provide a rich and detailed
measure of the biotechnology environment fora given economy. Below are the overall results
for the Biotech Policy Performance Measure.
Economies move from top to bottom in the figure
from those that have the most attractive policy
environments and accompanying high levels of
biotechnology outputs to those that have the mostchallenging environments for both policy inputs
and biotech outputs. (A full set of tables withresults for each indicator and inputs and outputs
for each economy is provided in the accompanying
Annex.)

Building the Bioeconomy 2019 44 economies by World Bank income group
Lower-middle-income
economies

Upper-middle-income
economies

High-income
economies

High-incomeOECD Members

Egypt

Algeria

Argentina

Australia

India

BrazilSaudi Arabia

CanadaIndonesia

China

Singapore

Chile

Kenya

Colombia

TaiwanDenmark

Nigeria

Costa Rica

UAE

Finland

Philippines

EcuadorFranceVietnam

Malaysia

Germany

MexicoIreland

Peru

IsraelRussiaJapan

South Africa

Lithuania

Thailand

New ZealandTurkeyNetherlands
NorwaySouth Korea
SwedenSwitzerland
UK
US

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BUILDING THE BIOECONOMY 6TH EDITION

The Biotech Policy Performance Measure – Overall results
Policy Inputs

Biotech Outputs

US
Denmark
Singapore
Switzerland
SwedenNetherlands
UK
Germany
FranceAustralia
Japan
Finland
Ireland
TaiwanCanadaKorea
Israel
NorwayNew Zealand
Lithuania
Malaysia
China
Chile
Saudi Arabia
Brazil
Costa Rica
UAE
Argentina
TurkeySouth Africa
RussiaMexicoThailand
Colombia
India
Peru
Kenya
Indonesia
Egypt
Philippines
Nigeria
EcuadorVietnam
Algeria
0

5

10

15

20

25

30
9

EXECUTIVE SUMMARY

Looking at the above indicators, the addition of
11 new economies (a growth of 33% in the samplesize) only strengthens the overall message ofprevious editions of the Measure: Inputs equal
outputs. There is a strong and sustained link
between creating a positive enabling policy
environment and achieving real-world biotech
outcomes. Economies that have weak enabling
environments – and perform worse relative to othereconomies on the indicators relating to policy
inputs – tend also to have lower biotechnology
outputs.
Another important take-away from the Measure isthat there is no shortcut to building a conducive
biotech policy environment. Each economy has its
own strengths, which it can leverage to enhance
its attractiveness vis-à-vis other markets. Some
– such as many Latin American countries – areblessed with rich and varied ecosystems thatprovide a strong starting point for biotechnologicalinnovation and R&D. Others – such as Algeria
and Norway – have benefitted from the inflow
of revenues from natural resources. But relying
only on intrinsic strengths cannot alone deliver
the expected economic and social benefits ofbiotechnologies. Small economies with limited
natural resources such as Israel, Denmark, Irelandand Singapore have had to rely more on ingenuity,
creativity and getting their incentives right tocreate an enabling environment for innovation.

Conclusions and recommendations
For six years, this report has reflected on how
the right policies can help build thriving biotech
sectors. This edition of Building the Bioeconomy
again makes it clear that the countries thatstand the best chance of enjoying the fruits ofbiotechnology innovation are the ones where
forward-looking regulations act to encourage, andnot hinder, innovation. Based on the analysis andmapping of the national innovation systems andbiotechnology policies and enabling factors inplace in the 44 countries sampled it is possible topiece together five universal recommendations.

10

They are:
1. C reate a national blueprint or plan of action– The existence and creation of a blueprint
or national biotechnology strategy can be a
powerful tool in creating a vision and setting
a goal for national aspirations. There aremany ways in which governments can provide
leadership and direction for the building of
biotechnology capacity. By and large mostcountries studied in this paper have directly
or indirectly targeted biotechnology as atechnology and industry of strategic importanceto national economic development and growth.
But not all 44 of the sampled countries havedeveloped national blueprints or plans fordeveloping the sector.
2. Execute – A national blueprint or plan of action
is a necessary starting point for all aspiring
biotech nations, but it is only the first step. Onceit has been formulated and drawn up it must
be implemented. Building a bioeconomy is nota short-term proposition. It takes long termplanning, patience and commitment. But where
many countries fall short is in their ability andefforts to move from a planning phase to actually
implementing and applying the necessary
policies. This is where the hard work begins.
3. M
 easure performance – The measuringof performance and the creation of key
performance indicators is critical. Without anunderstanding of whether or not implemented
policies are actually working it is impossible toproperly evaluate whether any progress isbeing made.
4. R ecognize and use existing best practices –Although no two countries are the same and allface different circumstances, countries can learn
from the experiences of each other.
5. Leverage national capabilities – Understanding
and focusing on one’s comparative andcompetitive advantage can lead to the mosteffective allocation of resources. Country size,
scientific and research strengths, geography
and biodiversity are all important attributes.
Some countries have natural strengths in somebiotech sectors whereas others can competeand develop across the board.

BUILDING THE BIOECONOMY 6TH EDITION

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12BUILDING THE BIOECONOMY 6TH EDITION

1INTRODUCTION
In 2015 the international community through the United Nations agreed to a
new socio-economic blueprint – the “2030 Agenda”, including 17 Sustainable
Development Goals and 169 targets.1 Some targets are societal in nature: they tackle
basic needs, access to services and poverty, and relate to human well-being. Others
focus on economic development and wealth creation. And there are also important
targets relating to the environment and resource security, health ecosystems andclimate change. It is an ambitious set of holistic global goals and aspirations.
1.1 Rising to the challenge –biotechnologies for sustainability
From a biotech perspective it is amazing to think
how biotechnology as such and the many different
biotechnologies are critical to achieving thesegoals.2 Biotechnologies provide in the healthspace new medical therapies and treatments (e.g.
immunotherapy and gene therapy), more effective
diagnostics, speedier and more targeted vaccine
production and personalized medicine. For
agricultural production biotech can help produce
crops resilient to extreme environments causedby climate change, improve yields and nutritional
value. In industrial development, biotechnology
can not only reduce costs for the productionof many human essentials but also reduce theenvironmental footprint for a given level ofproduction through for instance the developmentof new environmentally friendly fuels and sourcesof energy.3 As an application of biology forthe benefit of humanity and the environment,sustainability is intrinsic to biotechnologies.
Exploiting the role of biotechnologies as a longterm lever of sustainable and inclusive growth isboth an imperative and an opportunity.

1.2 Objectives of the 2019 edition of
Building the Bioeconomy
2019 marks the sixth edition of the Building
the Bioeconomy series. Since 2013 it has taken
the pulse of biotechnology policy frameworks
by looking at their developments and overall
performance in some of the major economies
around the world. The overriding goal of thisexercise has been to identify how successful
biotechnology sectors can be built andsustained. In addition to mapping policy trends

and monitoring changes, the last few editionsof the report have also assessed how different
economies are achieving their stated biotech
goals. This is done through the Biotech Policy
Performance Measure (the “Measure”), a
comparison of economies on 30 policy inputs
and biotech outputs showing how individual
economies’ policy environments affect theirsuccess or failure in creating thriving biotech
sectors.

1.3 Enabling factors for biotech success
Designing an environment that is conducive tothe innovation, research, commercialization andmarketing of biological products and technologies
is not an exact science. Different countries havegreater or lesser needs in specific policy areas.
Still, most countries that have been successful increating an environment conducive to biotech
innovation share some key enabling factors.4
The analysis and policy mapping of Building the
Bioeconomy is built around seven enabling factors
for biotechnology development. The factors
range from the institutional and eco-system level(such as levels of tertiary education, technical skill
and IP environment) to the more biotech specific(such as what type of biomedical and biotech
R&D infrastructure does a country have in place
and availability of technology transfer laws andmechanisms). Together these factors create theconditions that give countries and policymakers
the best chance of having success in developing
their biotech capacity and promoting biotech
innovation.
Below Table 1 provides an overview of thesefactors and a brief description of each.
13

1 INTRODUCTIONTABLE 1 Seven enabling factors for biotechnology innovation
Key enabling factors

Explanation

Human capital

A basic and fundamental building block for the biotech sector is the availability of high skilled andtechnically trained human capital. Without the right human capital it is virtually impossible to create theconditions in which biotech innovation can take place.

Infrastructure for R&D

Combined with having adequate, educated and technically proficient levels of human capital, R&D
infrastructure and capacity is critical to successfully fostering innovation and activity in high tech sectors
including biotechnology. Without the necessary laboratories and clinical research facilities biotechnology
R&D would be next to impossible.

Intellectual property
protection

IPRs (including patents and regulatory data protection) are historically of real importance to the biotech
and biopharmaceutical innovation process. For biopharmaceutical as well as non-pharmaceutical biologicalproducts and technologies the evidence suggests that IPRs incentivize and support the research anddevelopment of new biological technologies and products.

Regulatoryenvironment

The regulatory and clinical environment in a given country or region plays an important role in shaping
incentives for innovation and establishing adequate levels of quality and safety for biotech products,
particularly biopharmaceuticals. A strong regulatory environment creates the conditions for the production
and sale of high-quality products and technologies.

Technology transfer

Technology transfer is a critical mechanism for commercializing and transferring research from public andgovernmental bodies to private entities and private-to-private entities for the purpose of developing usable
and commercially available technologies.

Market andcommercial incentives

Market and commercial incentives range from general R&D incentives to specific policies aimed atbiotech sectors such as pricing and reimbursement policies for biopharmaceuticals. For thebiopharmaceutical sector incentives determined by pricing and reimbursement systems for medicinesand health technologies can have a profound impact on commercial and market incentives for innovationin health and biotech R&D.

Legal certainty(including therule of law)

The general legal environment including as it relates to the rule of law and the rule of law within a business
context is crucial to commercialization and business activities.

1.4 A wider sample ofnational biotech policies
This edition expands the analysis from 33 to 44 of
the world’s major economies and aspiring biotech
pioneers, providing a larger sample to examine
the main global trends and developments. On thenext page Table 2 lists the 44 countries included inthis year’s report according to World Bank income
level with the 11 new countries highlighted in bold.

1.5 Report overview
In addition to this Introduction this report consistsof three sections.
Section 2 provides a thematic analysis and overview
of the past year in biotechnology. It identifies
the main challenges for biotech development
across the countries analyzed. What are the main
constraints for biotech innovators? Are recent policy

14

BUILDING THE BIOECONOMY 6TH EDITION

initiatives helping or hindering faster technologicaladvances?
Section 3 zooms in on the 11 economies added tothis year’s edition. For each of them, the section
briefly presents the policy framework for innovation
and biotechnology: What is the role of innovation in
the country’s economy? Is a biotechnology vision or
strategy in place? Which biotech sectors are seen
as holding the greatest potential?
Section 4 describes the Biotech Policy Performance
Measure. It explains the 30 indicators used andprovides an overview of the underlying data that
feeds into the Measure. What do the results of the
Measure tell us about best practices for enabling
biotech innovation in the 44 economies sampled?

What can these economies learn from it and what
does it mean for other economies not included in
Building the Bioeconomy but aspiring to develop
their biotech capacity? (The full results including
all the underlying data for each of the 30 indicatorsfor each economy is included in an accompanying
Annex).
Section 5 ties together the analysis and databased insights of the preceding sections andpresents the main conclusions from six years of the
Building the Bioeconomy series.

TABLE 2 Building the Bioeconomy 2019 44 economies by World Bank income group
Lower-middle-income
economies

Upper-middle-income
economies

High-income
economies

High-incomeOECD Members

Egypt

Algeria

Argentina

Australia

India

BrazilSaudi Arabia

CanadaIndonesia

China

Singapore

Chile

Kenya

Colombia

TaiwanDenmark

Nigeria

Costa Rica

UAE

Finland

Philippines

EcuadorFranceVietnam

Malaysia

Germany

MexicoIreland

Peru

IsraelRussiaJapan

South Africa

Lithuania

Thailand

New ZealandTurkeyNetherlands
NorwaySouth Korea
SwedenSwitzerland
UK
US

Source: World Bank (2018)15

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16BUILDING THE BIOECONOMY 6TH EDITION

2

THE STATE OF GLOBAL BIOTECHNOLOGYIN 2019
The last twelve months have been an active time in the international biotech
community. In terms of news headlines, the main came from China in November
2018 with the announcement by Chinese scientist He Jiankui that he had used gene
editing technology on human embryos.5
This claim has yet to be independently verified
and the bulk of the scientific community –internationally and in China – have condemned
the purported research. Whether or not He was
successful, his claim has brought to the forefront
some of the most critical ethical considerations
and discussion on the use and application ofgenetic engineering techniques on humans.
More broadly, developments in international
politics during the course of the year have thepotential to have a major impact on virtually
all biotechnologies and sectors. Perhaps mostimportant of all is the trade dispute and tradenegotiations between the US and China.

2.1 The story of the early 21st century:
The rise of China
Apart from the fall of the Soviet Union arguably
the most important geopolitical development of
the past three decades has been the economic
development and growth of China. As a shareof aggregate global GDP China’s economy in1990 was a little bit bigger than Sweden’s andconstituted roughly 1.6% global output.6 While
American economic output as a share of global
GDP has largely stood still, as Figure 1 illustrates
below the growth of China over the last 30 years
has been breathtaking. By 2017 China’s economic
output was second only to the US and made up
over 15% of global GDP.

FIGURE 1 % share of global GDP, Current USD, 1990-2017, China and United States7
35%30%
26.49%

30.64%

25%

22.69%

24.03%

20%

15%
15.17%
10%
9.25%
3.61%

5%
1.60%
0%
1990
US

2000

2010

2017

China
17

2 THE STATE OF GLOBAL BIOTECHNOLOGY IN 2019

In just over one generation China has transformed
itself – and the global economy – from a
primarily agrarian economy to a global exporting
powerhouse. In 2017 China was the largest
trading nation in the world, Chinese exports
totalled USD 2.22trillion and its trade surplus wasover USD 400billion.8 China’s growth and socioeconomic transformation have had a profounddomestic impact: millions of Chinese have been
lifted out of poverty. Its international impact
has been heightened as it has coincided withdeep structural changes to the global economy.
Today’s global economy is inter-linked, interdependent and open for business in a waythat it was impossible logistically, politicallyor financially a generation ago. Indeed, thesum of the technological, cultural, politicaland socio-economic changes of the last three
decades amounts to what is truly a paradigm
shift. In 1990 the internet was not a commerciallyor publicly available entity. The Soviet Union,although crumbling, was still the world’s second
most important geopolitical bloc and one of its
largest economies. Just-in-time manufacturing
and the use of international supply chains were
not industry standards and are now the bases formuch of modern commerce. At the heart of allthese changes have been China’s development andgrowing importance within the global economy.

2.2 The future of global trading relations:
Effective market access and theprotection of IP
Market access and the protection of IP lie at theheart of the current trade dispute between the
US and China. Chinese policymakers have longrecognized the need to shift domestic economic
activity away from low added value industrial
production into higher value knowledge-creationand high-tech, advanced manufacturing andR&D. Successive Chinese administrations haveemphasized the need for investing in R&D
capacity, technology development, human capitaland incentivizing innovation. Specific policies
and plans range from the Five-Year Plans to plans
for Science and Technology Development to themore recent Made in China 2025. Underlying manyof these policies and plans is a focus on local
technology acquisition and development. For
example, there are a number of barriers in place18

for licensing agreements and entry into China thatboth directly and indirectly require localizationin order to access the market. Examples of suchpolicies include joint ventures and technology
transfer deals, whereby technology intensive
industries trade technology for market access or
government entities favor foreign suppliers thatprovide training services or transfer of know-how.
These agreements have been common practice in
China for several years, despite being prohibitedby the WTO.9 One illustration of this is the factthat while a specially reduced corporation tax
of 15% (compared to 25%) is in place for hightech companies, foreign entities must transfer
ownership of their IP to a local entity in orderto qualify.10 In addition, licensing of foreign IP
to local entities is subject to wide flexibilities
on the local entities’ part, including the ability
to make improvements or reverse engineer the
licensed asset without any ownership on thepart of the foreign rights holder.11 In the context
of standard setting, there is also a trend toward
greater administrative involvement in determining
patent licensing terms and the ability to secure
relief from infringement. Although some policies
have been revoked, many of these policies arestill in place and continue to be introduced. At
the heart of this policy has been the lure of theenormous potential of the Chinese market. While
all high-technology sectors have been affectedby these policies, biotechnology in particular
has been a focus of Chinese policymakers. China
has in various policies outright or indirectly
sought to link access to the Chinese market withmore favourable terms and/or restrict foreigncompetition for domestic producers. For example,
with respect to agriculture and production of
biotech crops, severe restrictions of access to theChinese market have hampered trade between
the US and China. The Chinese Ministry ofAgriculture and the National Biosafety Committee
are responsible for the regulation and approvalof imported agricultural GM products and/or thedomestic production of GM products in China.12
The regulatory pathway to commercialization has
not been easy to navigate either for international
or Chinese innovators as there are a number ofregulatory-related barriers to market entry. They
include: the requirement that a product must be
registered and approved in the country of export
prior to an application for approval can be made inBUILDING THE BIOECONOMY 6TH EDITION

China; and a requirement that import applications
include viable seeds.13 The latter requirement
has raised concerns among manufacturers
about the protection of their IP.14 Perhaps mostdamagingly of all are the long delays in market
approval for biotech events and products. A 2018
report suggested that these delays in Chinese
approval times had cost the major biotech crop
producers in the world (US, Brazil and Argentina)
billions of dollars in potential lost sales share.15
The direct and indirect negative impact on
the American economy was an estimated USD
14.8billlion in economic output.16 Similarly, for thebiopharmaceutical sector Chinese policymakers
have sought to make market access and IP
protection contingent on early product launches
and investment into the Chinese market. For
example, in 2016 The Work Plan for the Reform ofChemical Drug Registration Categories introduced
a definition for “new drugs” that required an
extensive level of investment – first global launchin China – in order to benefit from a range ofexisting advantages. Under the proposed policy
only drugs not yet marketed anywhere in the world

would be considered as “new” in China, and thus
qualified for certain benefits such as a five-year“monitoring period” (i.e. akin to RDP).17 Out ofaround 350 drugs approved in 2014, only 2.9%
were drugs that had not been marketed anywherein the world and none were the more advanced
biological drugs.18 Moreover, under proposedbiosimilar legislation, biologics reportedly must
not only have the first worldwide launch in China
but also be produced there in order to qualify
for the five-year marketing exclusivity.19 Whilethese policies were never fully implemented, as
is detailed below China is now proposing similar
measures and conditions with respect to periodsof patent term restoration.
Yet these trading challenges are not uniqueto China. As the following sub-section details,
biotechnology entrepreneurs and innovators
face similar issues of effective market accessand protecting their IP in many of the world’s
biggest markets.

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2 THE STATE OF GLOBAL BIOTECHNOLOGY IN 2019

2.3 One step forward, two steps back…
Looking at the seven enabling factors identified in
the Building the Bioeconomy series, it is clear that
one of the major challenges facing policymakers
is a lack of coordination and holistic thinking.
Simply put policy reform efforts in one policy area
are often counter-balanced or cancelled out by
negative action in other areas.
For instance, on the one hand, many countries
are moving ahead with positive reform efforts
in the space of speeding up drug marketing
approvals and R&D tax incentives. As was notedin last year’s Building the Bioeconomy, in many
countries drug regulators are responding to therapid pace of innovation and unmet medical needby introducing accelerated and/or abbreviatedmarket approval pathways. This trend has
continued in some major economies during
2018, most notably in China. During 2018 China
agreed to accept trial data from other countries
for drug marketing procedures, putting an end toa burdensome, time-consuming and expensive
requirement to enter the Chinese market.20 It also
streamlined trial approval procedures setting a
60-day approval target.21 In a further move to
make foreign drugs more rapidly available toChinese patients, the National Medical Products
Administration established a “special channel” forthe review and approval of new drugs approved
and marketed in the US, EU, or Japan in the past
10 years, but not yet approved in China.22 To thiseffect, the first Catalogue of Urgently-Needed
Overseas Pharmaceuticals contains 40 drugs forrare and life-threatening diseases for which notreatment is available or with a demonstrated
clinical advantage. Through this special channel,
the timeline for technical review will be shortened
to three months for orphan drugs and to six
months for treatments of life-threatening
diseases.23 More generally, improvements toapproval procedures have continued, and since2017 China has approved a record number ofinnovative foreign drugs. Finally, the Chinese
government has, starting from March 2019,
introduced a new preferential 3% VAT rate (versus
a standard rate of 16%) for 21 medicines and 4
drug substances used to treat rare diseases.24

20

Similarly, more countries are attempting toenhance their competitiveness by introducing
new R&D tax benefits or improving the schemes
already in place, often in the framework ofreforms to bring them in line with OECD BEPS
requirements.25 Of the economies sampled in the
Building the Bioeconomy series, in 2018 significant
improvements were registered in Singapore, whoraised its tax deduction rate and introduced apatent box regime – as did Switzerland.26 And
since the first quarter of 2019 a new R&D tax
scheme is also available to businesses in New
Zealand.27 Also Germany, who has traditionallyrelied on direct funding, is planning to introduce
R&D tax breaks to reach its target of allocating
3.5% of GDP to R&D.28
Nevertheless, despite important reforms suchas these, many countries continue to introduce
negative policies and raise barriers with respect totwo areas in particular: i) market and commercial
incentives, especially for biopharmaceuticalproducts; and ii) the protection of IP.

2.4 Cost control at all costs? Developments
in biopharmaceutical pricing policies
Pharmaceutical pricing and reimbursement (P&R)
policies are perhaps the most common set ofpolicies used by payers (government or private)
to control the cost of biopharmaceuticals. P&R
policies are used in all types of health caremarkets, whether they be OECD countries withsophisticated and well-developed health systems
or emerging and developing markets where, inmany cases, the health system is still being built.
The growing need for specialty drugs – estimatedat one third of total drug spending globallyin 201629 – and availability of new, life-saving
treatments add pressure on healthcare systems
that are already grappling with other long-term
structural factors such as ageing populations.
These pressures require long-term strategic andholistic thinking and a concerted policy approachtaking into consideration all parts of the healthsystem. Unfortunately, in many countries payers
are not engaging in systematic and holistic healthsystem evaluation and reform. Instead, much of
the effort is aimed at cutting spending on theperceived high cost of new medicines. This theme
has become particularly pronounced over the last

BUILDING THE BIOECONOMY 6TH EDITION

eighteen months, when health systems that havetraditionally valued biopharmaceutical innovation
appear to be shifting focus embracing cost control
policies that risk leading to less innovation andfewer new products.
Innovation strongholds playing with fireIn the US the cost of biopharmaceuticals is again
at the top of the policy agenda. Over the courseof 2018 the Trump administration has introduced
a number of reform initiatives aimed at lowering
the cost of prescription medicines. In February
2018 the Council of Economic Advisers (CEA)
released Reforming Biopharmaceutical Pricing
at Home and Abroad, an analysis of the global
biopharmaceutical market. A few months later
President Trump and the Department of Healthand Human Services also announced a set ofreforms in the blueprint document American
Patients First. And in October 2018 theadministration announced a plan to build an“International Pricing Index”. This Index would
seek to align Medicare payments for physician
administered drugs under the program with theprevailing prices in 14 countries, some of whichwith a significantly lower purchasing power (e.g.
Greece, Czech Republic) than the US.30 Given
the experiences of other countries and the useof international reference pricing, it is more likely
than not that the introduction of such a mechanismon the American market would have a deep andnegative impact on long-term innovation andR&D. It is worth noting that one of the strongest
drivers of biopharmaceutical innovation in the US
has been the existence of a relatively free market
in the pricing of pharmaceuticals. While the priceof prescription medicines is a hot button issue forthe public and elected representatives, the overall
context of pharmaceutical pricing and health careaccess is often overlooked. To begin with, one fact
often ignored in this debate is that as a proportionof overall health care spending, expenditure onprescription drugs represents a relatively small
share of health care spending in the US at around
12% of total spending according to the OECD.31
Similarly, the US has by far the highest availabilityof new and innovative products, being the first
country of launch for the vast majority of new andinnovative medicines. For example, IMS Healthlooking at the availability of new molecular entities(NMEs) in different countries between 20082014 found that, out of 154 NMEs introduced,
104 were available in the US; the second highest
penetration rate was in Germany, where only 82
products had been introduced, 22 less than in the
US.32 Looking specifically at the 16 countries usedin the IPI proposal, the US Chamber of Commerce
has noted that over the past seven years, 32 fewer
drugs were available for the treatment of cancer
in these countries.33 Finally, the vast majority of
global medical and biopharmaceutical innovations21

2 THE STATE OF GLOBAL BIOTECHNOLOGY IN 2019

currently take place within the US and a handfulof EU countries (Denmark, Germany, France,
Switzerland etc.). Looking at historical data on
global NCEs developed by firm nationality for thetwo decades between 1982-2003, Grabowski et alshow that out of the 919 NCEs analyzed only 20(or just over 2%) were developed outside the US,
EU and Japan.
While in the US these discussions are only atthe early stages, other countries that havetraditionally been viewed as leaders on global
innovation are embracing even harsher policies
of biopharmaceutical cost-containment. An
increasingly challenging pricing environment istarnishing Japan’s status as a biopharmaceuticalinnovator. Specifically, the Central Social Insurance
Medical Council (Chuikyo) has significantly
restricted access to the Price MaintenancePremium (PMP), a scheme that recognizes the22contribution of innovative drugs to patients and tothe health system. The new PMP criteria introduce
what is in effect a localization premium. Products
and companies are prioritized on the basis of local
research conducted with evaluation parameters
including the number of recent local clinical
trials, drug launches in Japan and ‘Sakigake’status. Almost one in three patented drugs lostthe PMP under the new criteria, particularly
foreign ones.34 Since it was introduced in 2010
the PMP has been fundamental to reforming
Japan’s P&R environment. It has resulted in moreinnovative drugs being introduced onto theJapanese markets and cuts in market approvaltimes.35 Furthermore, the Chuikyo has revised its
pharmacoeconomic system of analysis throughthe use of a revised HTA methodology. Healthtechnology assessment is an important tool ofanalysis and can assist payers to understandand make decisions on resource allocation.

BUILDING THE BIOECONOMY 6TH EDITION

However, any pharmacoeconomic system relieson the underlying assumptions and evaluation
criteria. The new HTA system in Japan is basedaround a fixed QALY threshold of JPY5 million(circa USD 45,000), to be raised by 50% fororphan, pediatric and anti-cancer drugs.36 Only
drugs used uniquely for pediatric conditions orrare diseases with no current treatment will be
exempted from the HTA.37 At the time of research
it was not clear the extent to which this QALY
threshold would be applied and if there would
be any discretion for medicines priced higher
but providing a concomitant therapeutic benefit.
During the initial trial period of the new HTA
criteria a number of products saw substantial
price cuts.
Another high-income market that has recently
proposed measures directly aimed at reducing
innovative drug prices is Canada.38 Canada has
introduced a proposal to change the fundamental
basis of the Patented Medicine Prices Review
Board (PMPRB) evaluation and the setting ofprices for patented medicines.39 Traditionally the
PMPRB monitors and sets the price of patented
medicines judging whether a price is “excessive”
for new and existing patented drugs. The PMPRB
has used a two-step process to set and review
prices for new patented drug products including a“Scientific” and “Price” review. The purpose of thescientific review process is to establish the “levelof therapeutic improvement of a patented drug
product”, an assessment made by the Human
Drug Advisory Panel. With respect to pricing levels
and what was judged to be an “excessive” price,
the level of therapeutic improvement determined
the pricing methodology and point of comparison,
which includes international reference pricing(IRP) price comparisons with drugs of the same
therapeutic class (TCC test). The new proposal
would fundamentally change the evaluation
process: it would change the pricing methodology
and points of comparison, including expanding
the basket of countries used in the IRP process.
The change of this mandate and pricing system
is likely to have a substantial negative impact.
Industry estimates that the change of reference
countries for IRP alone could result in a 10-15%
price reduction, while overall the reform could
slash prices of innovative drugs by at least 20%.40

Local preferences and mandatory localization
requirements
Another economy that stands out for its strict costcontainment policies is Korea. On the one side,
Korea continues to allocate considerable funds
to R&D and improve the regulatory environment,
most recently with the announcement of a‘regulatory sandbox’ for innovative industries.41
On the other, it has in place a strict P&R systemapplicable primarily to innovative products.42
Mandatory price cuts have been instituted
through a therapeutic reference pricing systemthat places innovative and generic drugs in thesame basket, with prices set based on the average
price in the basket.43 The innovative or therapeuticvalue of a given product is not factored into
the price.44 As a result of such punitive system,
over the past four years, the price for patented
medicines in Korea has fallen by an average of
17%, which is two times lower than the average
OECD countries average drug price cut rate of
9%.45 Between 2007 and 2012, ten new drugs foradvanced-stage or rare diseases became nonreimbursable despite the fact that they wereclinically useful and lacked alternatives.46 Over thelast few years Korea has introduced a number ofchanges to its pricing and reimbursement policies
that favor local manufacturers and penalize foreigncompanies. The Reform Plan for Reimbursement
Prices of Biopharmaceuticals and Global Innovative
Pharmaceuticals, presented in June 2016, grants
price preference to locally developed innovative
drugs. The Plan increases by 10% the prices ofbiosimilars tested in local trials and developedby companies designated as innovative (mostly
Korean) or jointly developed with a Korean
firm.47 Only two out of the 47 biopharmaceuticaldrugs designated as innovative are by foreigncompanies, although many more invest in
local clinical trials.48 Companies designatedas innovative receive special tax benefits,
preferential governmental research funding andpostponement of drug price discounts.49 In therevised South Korea – US (KORUS) agreement
reached in September 2018, Korea committed
to create a level playing field for local andforeign drugs, granting access to the 10% priceincrease foreseen by the Premium Pricing Policy
for Global Innovative New Drugs to all drugs,
irrespective of their origin.50 Currently, one of23

2 THE STATE OF GLOBAL BIOTECHNOLOGY IN 2019the requirements is that the new drug must be
released in Korea before being released in othermarkets, thus discriminating against non-Korean
manufacturers.51
Another, more blatant case of preferences for
local drugs in P&R policies is Turkey. More – andmore targeted – localization measures for thebiopharmaceutical sectors have been put inplace in a bid to implement localization targets.
Such key policies include import substitution,52
procurement preferences and pricing andreimbursement preferences for local products, butalso product registration preferences and local
GMP certification. Most recently, Turkey’s New
Economy Program 2019-2021 continues the policyof localization and of targeting import-intensive
industries and increasing domestic production
with the view of lowering the current accountdeficit and over the long term develop Turkey’s
technological and export capacities.53 In addition
to the above-mentioned policies, the government
has committed to provide direct and tax incentives
for the local manufacturing of 20 drugs relying
on foreign know-how.54 In reply to this large
set of mandatory localization and tech transfer
requirements, the EU initiated in April 2019 a
dispute at the WTO, claiming that these measuresviolate Turkey’s WTO obligations to treat foreigncompanies on equal footing with domestic ones,
and to protect the intellectual property of foreigncompanies.55

2.5 Growing headwinds for IP protection
As highlighted in previous editions of Building
the Bioeconomy, the twin factors of, one, thegrowing importance of biotechnologies toeconomic growth and development and, two, therising cost of many of these technologies meanbiotechnology innovators are increasingly seeing
their IP rights encroached and curtailed in. This isespecially the case for biopharmaceutical rightsholders. International experience and the basic
economics of the biopharmaceutical industry
show how critical IP rights are to incentivize
and support the research and development of
new medical technologies and products.56 In
particular patents and other forms of exclusivity
for biopharmaceuticals, such as regulatory dataprotection (RDP) and special exclusivity incentives

24

for the protection and production of orphan
drugs, provide research-based companies withan incentive to invest vast sums in R&D and thediscovery of new drugs, products and therapies.
Yet, regulators globally – even those who have so
far benefitted to large amount of R&D investment
thanks to their IP regime – are tinkering with IP
rights, unduly interpreting the meaning of IP
exceptions and making them an instrument toachieve other policy objectives, such as reducing
the ‘drug lag’.
After an informal agreement between thethree main EU institutions was reached in
February 2019,57 legislation introducing an SPC
manufacturing waiver is expected to receive
final approval by the EU Council and enter into
force in July 2019. Companies will be able tostart manufacturing under the waiver from July
2022. Apart from the obligation to mark products
produced under an SPC waiver for export as“export-only” and a general notification system,
no other safeguard to protect against a possible
diversion in the EU market of generics andbiosimilars covered by an SPC has been includedin the final text. Generic or biosimilar producers
will need to notify regulators in the Member State
where production will take place and the SPC
holder three months before production begins.
As noted in last year’s edition of the Building
the Bioeconomy, the overriding purpose of the
SPC waiver is, by weakening IP protection for
innovators, to provide European manufacturers
of generic drugs and biosimilars a competitive
advantage in global markets. Unfortunately, theCommission appears to have lost sight of the factthat IP incentives, including SPC protection, havebeen central to the success of Europe’s researchbased biopharmaceutical industry. The overall net
effect of the SPC exemption may thus be a limited(if any) gain to the European generics industry
and a weakening of the research-based industry
through a direct loss of sales and a collective
weakening of the global IP environment.58
In a similar vein, Canada has introduced provisions
that completely undermine the spirit of recent
positive reforms and the supposed strengtheningof biopharmaceutical IP rights. Following theimplementation of the Comprehensive Economic
and Trade Agreement, Canada introduced

BUILDING THE BIOECONOMY 6TH EDITION

a new regulatory scheme allowing for somecompensation for delays in obtaining marketing
approval for biopharmaceutical products.
The relevant amendments made to the Patent
Act (sections 106-134) and implementing
regulations published in the Canada Gazetteprovide a maximum restoration period of two
years through a Certificate of SupplementaryProtection (CSP) mechanism. While overall this isa positive step and an improvement, in Canada’s
biopharmaceutical IP environment there remain
significant areas of concern. To begin with, under
section 116(4) the Canadian government retains
the right to reduce the term of protection at its
discretion. Specifically, this sub-section states that:“the Minister may, if he or she is of the opinion
that that person’s [the rights-holder’s] failure toact resulted in a period of unjustified delay in theprocess of obtaining the authorization for sale,
reduce the term of the certificate when issuing
it by the amount of that period.” No further
definition of what constitutes an “unjustified
delay” has been provided in any of the relevant
regulations, which leaves a broad scope forinterpretation with the Canadian government.
Moreover, the implementing regulations containa ‘Timely Submission Requirement’ which sets atimeline for the submission of CSP applications
based on the regulatory status of a given productin a set of ‘prescribed economies’. The net
effect is that the availability of a CSP is being
made contingent on early market entry. Equally
troublingly, the law also contains an export clawout, with section 115(2) effectively exempting theinfringement of CSP protection if the activity isfor the purposes of exports. It is unfortunate thatthe law has undermined a positive and necessary
incentive by limiting the actual protection
afforded with these additional requirements andexemptions.
In a further blow to IP owners, in India the Delhi
High Court in April 2019 dismissed the appeal
of a 2017 ruling and authorized the export ofgeneric versions of patented drugs “provided theseller ensures that the end use and purpose ofsale/export is reasonably related to research anddevelopment”.59 The decision concerns sorafenib
and rivaroxabin, two active ingredients used
respectively for a proprietary cancer drug andblood thinner.60

And, as mentioned above, China is also pursuing
reforms to its IP laws. In January 2019 China tabled
Draft Amendments to the Patent Law, the fourth
version of the draft presented since 2012.61 The
Draft Amendments propose to extend by 5 years
the term of protection for patents to compensate
for regulatory delays (PTE system).62 They also
propose to enhance available damages for patent
infringement, including increasing statutory
damages from 1 million to 5 million RMB Yuan(around 700,000 USD).63 Yet, the proposed PTE
system has important flaws: firstly, it applies only
to innovative drugs marketed simultaneously in
China and abroad, secondly, the draft limits thetotal effective term of the patent to 14 years after
being placed onto the market.64 At the time ofresearch it was not clear what “simultaneous”
would actually entail. Unfortunately, the new draftis silent on the patent linkage system proposedin 2017 (Circular 55), which could in the best casebe left for administrative regulation.65 As a firststep in establishing a patent linkage mechanism,
the Chinese FDA issued the China Marketed
Chemical Drug Catalogue, a Chinese version of
the Orange Book that contains information on
both generic and patented products approvedin China. Yet, since the system was presented
in the ‘Innovation Opinion’ published October
2017, no implementing legislation has been
adopted. The lack of protection from genericcompetitors is the main stumbling block for life
sciences companies willing to enter the Chinese
market. Prompt implementation of the proposedsystem is key to achieve greater investment
and global competitiveness in this field. Finally,
the 2018 draft Pharmaceutical Data Exclusivity
Implementing Rules proposed to extend RDP tobiologics, orphan and pediatric drugs. Yet, also
this proposal disproportionally favors drugs first
filed in China. The draft raises RDP to 12 years
for new biologics and 6 years for new chemical
entities (NCEs) from global launch, provided thatthe application is based on domestic clinical trials(or multi-center trials that include China).66 If adrug is first approved overseas, a “drug lag” time
will be deducted from the protection term. In caseof applications based on overseas clinical data,protection is curtailed to 3 years for biologics
and 1,5 years for NCEs.67 This would severely limit
the effectiveness of this incentive and protection
mechanism. Under ongoing trade talks with25

2 THE STATE OF GLOBAL BIOTECHNOLOGY IN 2019

the US, the proposal to raise RDP to 8 years forbiologics has been mulled.68

2.6 A ray of light? NAFTA 2.0
Historically trade agreements have been
fundamental in setting international standards
for the protection and enforcement of IP rights.
TRIPS, NAFTA and numerous US and EU led
bilateral agreements have helped improve theglobal IP environment and set a floor for rightsholders around the world. The agreement
between the US, Mexico and Canada on a revisedand substantially strengthened free trade pact
in the United States-Mexico-Canada Agreement(USMCA) has the potential for setting a new
standard for global biopharmaceutical IP rights.69
NAFTA entered into force on January 1, 1994.
At the time, it was widely considered as the firstinternational trade agreement that included
specific obligations to protect IP rights. Indeed,
the NAFTA IP Chapter was the precursor to the
TRIPS Agreement – considered by many to be the26most comprehensive and ambitious multilateralagreement ever reached in the IP domain70 –which was signed in 1995 and has been ratified
by 164 economies. For a quarter of a century,
NAFTA has stood as a model for a regional trade
agreement. However, the economic relationships
between nation-states are fundamentally different
today than they were in the early and mid1990s. Dramatic changes in technology and thestructure and integration of the global economy
require future trade agreements to be morecomprehensive and detailed than preceding trade
agreements. The USMCA provides the potential
for a clear and forward-looking international
benchmark on IP rights and would set not only an
important precedent for future American trade
agreements, but also provide a global standard forwhat IP protection in the 21st century should look
like. Although chapter 20 of the Agreement covers
all major IP rights, for biopharmaceuticals andthe biotechnologies specifically the agreement
contains numerous important provisions including:BUILDING THE BIOECONOMY 6TH EDITION– stronger pharmaceutical-related IP protection
including:›A rticle 20.F.13: Protection of Undisclosed Test
or Other Data; and Article 20.F.14: Biologics
which provide a regulatory data protection
terms of 5 years for new chemical entities(NCEs) and 10 years for biologics; and› Article

20.F.11: Patent Term Adjustment for
Unreasonable Curtailment which provides aterm of patent restoration for pharmaceuticalproducts defined as “an adjustment of thepatent term to compensate the patent owner
for unreasonable curtailment of the effective
patent term as a result of the marketing
approval process”– Article 20.F.1: Patentable Subject Matter statesclearly that with respect to biotechnology
patentability patents shall be made available “atleast for inventions that are derived from plants”.
In addition to strengthening the provision of
IP rights the USMCA’s chapter 3 also contains
specific provisions relating to biotechnology.
Specifically, section B is dedicated to agricultural
biotechnology and emphasizes “the importanceof encouraging agricultural innovation andfacilitating trade in products of agricultural
biotechnology”.

– Article 20.I.1: Civil Protection and Enforcement;
Article 20.I.2: Criminal Enforcement; Article
20.I.5: Confidentiality which provide more
effective trade secret protection including
criminal sanctions.

27

SECTION

28

BUILDING THE BIOECONOMY 6TH EDITION3ZOOMING IN ON THE NEW COUNTRIESSAMPLED IN BUILDING THE BIOECONOMYThis year’s edition of Building the Bioeconomy adds 11 new countries to the existing
sample of 33 bringing the total number of countries included in the report to 44. The
11 new countries added are a good mix of middle-income and high-income OECDmarkets. This section discusses some of the key features of these countries’ nationalinnovation systems, their current biotech capacity and what they are individually
doing to build and develop their biotechnology capabilities.
3.1 Laying the foundation: Algeria, Ecuador,
Kenya, Nigeria and the Philippines
This year’s edition adds a group of five non-OECD
middle-income countries:– Kenya, Nigeria and the Philippines (lower-middle
income countries); and– Algeria and Ecuador (middle-upper income
countries).
When it comes to innovation and biotech
policies, these economies share some common
features. All are undertaking efforts to develop
their national biotechnology sector as a way tomove up the value chain and transition towards
a knowledge economy, though only somehave a dedicated biotechnology policy withclear objectives in place. In particular, Kenya
and Nigeria have established a basic legal andinstitutional framework covering many of the key
biotechnology issues. All are investing in research
infrastructure, often with a flagship innovation hub
or city built from scratch, such as Sidi Abdellahin Algeria,71 Konza Technopolis in Kenya,72 andYachay City of Knowledge in Ecuador.73 Yet, ingeneral, limited resources (including humancapital) and funding hinder their efforts to step up
the quality and quantity of research.
Of note is how none of these five countries hasrecognized the role of IP as a key incentive toinnovators. All lack fundamental IP standards,
particularly with regard to patents and theenforcement of IP rights. In fact, Ecuador has

been moving in the opposite direction than many
emerging economies by significantly weakening its
national IP environment generally and specificallyas it relates to biopharmaceutical IP rights.
What is more, some of these countries are resortingto mandatory localization and manufacturing as atool to develop their biotech industry.
Algeria has for several years imposed
protectionist-style rules for how foreign firms may
participate in the market, with the government
actively pursuing an import substitution policy.
The stated objective of these rules is to reduce
imports, encouraging domestic production andmaximizing technology transfer. Although largely
emanating from the oil and gas industry, thesepolicies run across various sectors and both
directly and indirectly affect biotech innovators
by imposing de facto localization requirements
in return for market access. For example, on thebasis of a pre-existing measure in the oil andgas sector, the 2009 Complementary Finance
Law limits foreign investment to a minority stake(49% or below) in any industrial sector. The
effect of this requirement is to impose a de facto
localization requirement for foreign firms wishing
to operate in Algeria directly or through licensing
agreements. There are also rules targeting
particular sectors. For example, the most stringent
localization policies adopted in Algeria thattarget medicines specifically are outright importbans and quotas placed on biopharmaceuticalproducts. Restrictions on drug imports have beenin place since October 2008 and have been further
expanded since then.

29

3 ZOOMING IN ON THE NEW COUNTRIES SAMPLED IN BUILDING THE BIOECONOMY

Nigeria’s drug authority NAFDAC in 2019presented a new requirement that foreign
biopharmaceutical manufacturers re-registering
their products partner with local Nigerian entities
and/or commence local manufacturing of theseproducts.74 For these drugs, the renewal ofmarketing approval is subject to the presentationof plans for local manufacturing or partnership.
Submitted plans will need to be implemented by
the end of the renewed approval term.75 At thetime of research, it was not clear how the policy
would be applied and the extent to which somemanufacturers will be exempt. The new policy
states that “The migration to local manufacturing
will be limited to products the local manufacturers
have capacity to produce”.76
Finally, only the Philippines (and to a lesser
extent Nigeria) has embraced agricultural
biotechnologies, despite the potential positive
impact in terms of food security for countries withlimited arable land, such as Algeria, or needingfood aid assistance, such as Kenya and Nigeria. An
outright ban both on the import and cultivationof biotech crops is in place in Algeria and – as perart 401 of the Constitution – in Ecuador. Kenya has
put in place an institutional and legal framework
for the adoption of GE crops and is close tocommercializing Bt Cotton for production;77 yet, it
has also banned the import of GE products since2012. In Nigeria, on the other hand, Bt Cotton wascommercialized in 2018, and other products are
already at different stages of field and confined
field trials.78
Country-by-country biotech overview
With a few exceptions, such as the
Biotechnologies Research Center of Constantine,79
biotech and general R&D represents a peripheral
activity in Algeria in both the business and public
sectors. Algeria does not currently have in placea clear biotechnology strategy or official policy.80
Nonetheless, the government has recognized
the socio-economic potential of biotechnology
and specifically of the biopharmaceuticalsector.81 In this regard, it has expressed the goalof attracting biopharmaceutical investment,
increasing local production to cover 70% ofnational demand by 2019,82 and creating “theleading biopharmaceutical cluster of the MENA

30

region by 2020” in Sidi Abellah.83 Looking
at a range of outputs Algeria has so far notachieved its stated goals and ambitions. On thecontrary, the country underperforms many of
its peers in terms of FDI and clinical activities.
As is detailed below Section 4’s Biotech Policy
Performance Measure and accompanying
Annex, Algeria has across the board the lowest
biotechnology and biopharmaceutical outputsof all 44 countries included in this edition of
Building the Bioeconomy. Why is this? There aresubstantial gaps in key policy areas and enabling
factors. This includes: the regulatory space;commercial and market incentives (including
biopharmaceutical pricing and reimbursement
policies); and inadequate protection of IP.
Localization and investment policies aimed atfavoring local production – such as the longstanding 51% local ownership obligation andprocurement preferences – act as a disincentive
to foreign partnering and investment, especiallyfor R&D.84 Algeria prohibits imports of almost
all biopharmaceutical products that competewith similar products that are manufactured
domestically. To date, 357 products are listed as
excluded from import, while annual import quotas
are in place for products that are not locallymanufactured.85 Recurrent delays in approving
such quotas also disrupt supplies to both patientsand local manufacturers. Finally, given the current
political unrest, there is a high level of uncertainty
as to the policy environment and the future
direction of Algerian biotechnology policy.
Of the five new lower-middle income countries
included in this year’s sample Kenya is thepoorest with the lowest GDP per capita, ataround USD1,500 in 2017. Yet despite this,more than many richer countries, Kenya hastaken tangible steps to build a functioning STI
institutional system. This includes: creating the
National Commission for Science, Technology
and Innovation;86 the Kenya National Innovation
Agency; and a National Research Fund. The
government has also developed several national
economic plans that attempt to integrate STI
in the national production process to enableeconomic development. This includes the
Vision 2030 87 and the more recent President’s
Big 4 Agenda.88 Specific to biotechnologies, in2006 Kenya developed a comprehensive national

BUILDING THE BIOECONOMY 6TH EDITION

policy to guide research, development and thecommercialization of modern biotechnology
products.89 The strategy emphasized the
medical application of biotechnology.90 There
are also plans for a dedicated Biotechnology andBiosciences Programme including the creationof biotechnology Centers of Excellence, and anational Biotechnology Development Policy.91
For ag-bio, while there exists a structured policy
framework, there is real uncertainty over thebiotech crop policy environment; in 2012 there wasa GE food import ban.
Nigeria is Africa’s largest economy and mostpopulous country. Like Algeria, the country
is largely dependent on oil and gas, and has
struggled to diversify its economy. Unlike Algeria,
however, agriculture accounts for a large shareof GDP and employment. Similar to Kenya,
Nigeria has put in place a legal and institutionalinnovation policy framework to foster innovation.
This includes a national STI Policy,92 a National
Science Technology and Innovation Roadmap(2017-2030),93 a National Research and Innovation
Council94 and, since 2018, an Advisory Group on
Technology and Creativity.95 In 2001 the Federal
Executive Council adopted a biotechnology
policy and approved the establishment of the

National Biotechnology Development Agency 96
to promote, coordinate and deploy cutting-edge
biotechnology R&D, processes and products
covering agricultural, medical and environmental
biotech.97 In 2015 Nigeria established the National
Biosafety Management Agency to oversee
the use and commercialization of ag-biotech
products and strengthen Nigeria’s food security.
Yet, in spite of these initiatives, public support
for biotechnology development and innovation
remains low. In addition to low levels of investment
in research, lack of infrastructure and skilledhuman capital, major policy roadblocks exist in
the form of inadequate IP protection, government
intervention in private licensing activities, andforced localization.98
In the Philippines there are also ongoing efforts tobuild a national innovation policy. The Philippine
Innovation Act was passed in 2017 and provides
for the establishment of a National Innovation
Council and a National Innovation Fund.99 Thereis a bill to encourage start-ups, the Innovative
Start-up Act.100 Looking at biotechnologies
the policy environment is somewhat mixed
depending on the sector and type of technology.
For biopharmaceuticals the regulatory capacity
remains limited, though the authorities havetaken some steps to tackle the long approval
backlog.101 Other shortcomings include domestic
procurement preferences, a lack of commercial
and market incentives (including offset programsfor medicines) and a generally limited national
IP environment. In contrast, when it comes toag-bio, the Philippines has a solid track record
as regional biotechnology leader. Biotechnology
programs were first started back in 1980 andhave multiplied during the years.102 In 1990 thePhilippines was the first ASEAN country to initiate
a biotechnology regulatory system based on strict
scientific standards (Executive Order No. 430) andestablished the National Committee on Biosafetyof the Philippines. In the same year, a Master
Science Plan by the Department of Science andTechnology identified biotechnology as a highpriority sector.103
Ecuador has been actively pursuing a nationalinnovation agenda with the direct participationand engagement of its general population. In
October 2016 Ecuador’s National Assembly31

3 ZOOMING IN ON THE NEW COUNTRIES SAMPLED IN BUILDING THE BIOECONOMY

passed the Código Orgánico de Economía
Social del Conocimiento, la Creatividad y laInnovación (Código Ingenios). The legislation
touches on all facets of IP rights, research anddevelopment and innovation. While the law
aims to encourage innovation, R&D and thedevelopment of new technologies, it contains
a strong element of local preferencing anddiscrimination against foreign companies. The
legislation also contains a number of negative
provisions relating to existing patent laws andpractices and trademarks. For example, articles
268 increases the number of non-patentablesubject matter and article 274 eliminates any
patentability of second use inventions. Whilethe latter is part of Andean Decision 486 thishad nevertheless not been codified previously in
Ecuador’s existing Intellectual Property Law. With
regards to the protection of trademarks the termof protection has been amended with renewal
periods under article 365 limited to 2 renewals.
This markedly stands in contrast to TRIPS article 18
which states that “the registration of a trademark
shall be renewable indefinitely”. In addition, aseries of policies have been initiated including
the Agendas of Productive Transformation (2013),
the Strategy of Change of the Productive Matrix(2015),104 the 2016-2025 Industrial Policy and the
Buen Vivir National Plan (2017-2021).105 Biotech,with an emphasis on industrial and environmental
biotechnologies, has been identified as needed
to develop the country’s new productive matrix.
The Buen Vivir National Plan states that Ecuador
will “give space to researchers and entrepreneurs
to open up the possibilities to bio-knowledge,
the bio-economy and biotechnology”. The planalso mentions the preparation of a National
Bio-knowledge and Biotechnology Strategy. Yet,despite these ambitions, Ecuador has not beenable to change the fundamentals of its economy.
Overall the economy remains focused on low
productive sectors and very limited, incremental
innovation.106 As is detailed below in Section
4’s Biotech Policy Performance Measure andaccompanying Annex, Ecuador has some of thelowest biotechnology and biopharmaceutical
outputs of all 44 countries included in thisedition of Building the Bioeconomy. In large
measure this is due to a fundamentally negative
policy environment. Indeed, the government
continues to actively pursue an innovation

32

policy that undermines or weakens IP protection
including the use of compulsory license forbiopharmaceutical products. Ecuador has since2010 been an active user of compulsory licensing
for biopharmaceutical products. Nine licenses
have been granted since 2010 and more are being
considered. These licenses have been issued on abasis of being a cost containment mechanism andpolicy of encouraging domestic innovation, importsubstitution and industrialization.

3.2 Reaching for biotech excellence:
Canada, France, Germany, Lithuania, theNetherlands and Norway
The Building the Bioeconomy 2019 also adds agroup of six high-income OECD members: four
EU members – Lithuania, France, Germany, theNetherlands – and Canada and Norway.
To varying degrees, all these countries haveresearch structures in place and look atbiotechnologies as a key enabler of future growth.
Some, notably Lithuania and to a lesser extent
Norway, have joined the race more recently,
but are making strides to compete. In France,
Germany and the Netherlands strategies tofoster both medical and industrial/bio-based
products have been put in place, but like most
EU Member States agricultural biotechnologies
have been marginalized or banned. In Norway themost promising applications of biotechnologies
are in the area of industrial and environmental
biotechnology. Only Canada has moved toreap the economic, health and environmental
benefits of agricultural biotechnologies, witha well-established scientific approach in placesince 1983107 and a series of ag-biotech clusters,108
including the most recent protein industrial
supercluster.109
Country-by-country description
In Lithuania the life sciences are estimated toaccount for more than 1% of national wealth – sixtimes the EU average.110 The country aims to raise
this share to 5% GDP by 2030.111 More than 130
life sciences companies are currently operating in
Lithuania,112 and the biotech and pharmaceuticalresearch and manufacturing sector is reported
as growing at approximately 14% annually.113

BUILDING THE BIOECONOMY 6TH EDITION

This small country of 2.8 million inhabitantshas developed relatively strong capacities withregard to skilled human capital. As reported by
its Education Minister, Lithuania has one of thehighest density of biomedicines and technology
students in the EU114 and has achieved several
critical scientific breakthroughs. For instance,
scientists from the Vilnius University Institute of
Biotechnology were among the first to discover
the gene-editing potential of the Cas9 proteins,and in 2017 were granted a US patent relating to
CRISPR-Cas technology.115 The country has also
made strides to develop research infrastructure
and its technology transfer capacities. The Vilnius
University Life sciences Center provides a state-ofthe-art facility for education, training and researchin life sciences.116 It also provides a bio-incubator.
Vilnius University is also part of the Sunrise
Valley Science and Technology park.117 118 Other
integrated science, study, and business valleys
have been established as part of the ministriesof Economy and Education’ efforts to promote
innovation. The fruits of these positive policies
can be seen in high levels of biotech outputs. For
example, with respect to clinical research Lithuania
is a global leader with more than 320 trials per
million population to date. Similarly, Lithuania has
high levels of trials on biologic medicines and earlyphase biologic research.
In Norway, the government is striving to enhance
the contribution of the research and innovation
system to its economy.119 Norway dedicatesa high level of public spending in support of
R&D, and has a history of high-tech innovationand technical skills in the oil and gas andaquaculture industries. The National Strategy for
Biotechnology 2011-2020 identifies four thematic
areas in which biotechnology can play a rolein addressing social challenges: industrial andenvironmental biotechnologies, health biotech,but also aquaculture and fisheries, and landbased food and biomass production.120 A National
Bioeconomy Strategy issued in 2017 focuses
both on traditional bio-based industries such as
agriculture, forestry, fisheries and aquaculture, andon newer applications related to energy, waste,chemicals, health, climate and the environment.121
In 2018 Norway was the first country to ban palm
oil for biodiesel122 and to introduce a biofuel
blending mandate for jet aviation.123 At present,

traditional bio-based industries (agriculture,
forestry, fisheries and aquaculture) account forroughly 6% of the Norwegian economy.124 Yet,biotechnologies are not used transversally in allthese areas. Indeed, due to the Gene Technology
Act, no GMOs are grown or sold in Norway.125
Like many OECD economies Canada has anadvanced research and innovation agenda.126
There is a high-skilled and highly-educatedworkforce, generous tax incentives and a relatively
high level of R&D spending. Yet like many highincome OECD economies Canada has struggled
to translate its technical skills, human capitaland research infrastructure into IP assets andcommercialized products. To help overcome thesechallenges, the government in 2017 launched
A nation of Innovators – Innovation and Skills
Plan.127 The Plan identified six sectors where
Canada could become a global leader, including
biotechnology.128 Yet, there are many fundamental
challenges to Canada achieving these goals.
For a high-income developed OECD economy
Canada has one of the weakest national IP
environments. Also, pricing methodology reforms
for biopharmaceuticals proposed by the Patented
Medicine Prices Review Board are likely to havea negative impact on incentives to innovate andR&D.129 No specific life science strategy exists at
the federal level to ensure a whole-of-government
approach.130 Instead some of the bigger provinces
have forged ahead independently and developed
their own strategies and policies. This includes
for example Quebec, which in 2017 launched its
own life sciences strategy. Ontario has also been
active and has established a office dedicated tosupporting a whole-of-government approach tohealth innovation, the Office of the Chief HealthInnovation Strategist.131 Finally, consultationis ongoing to develop a national strategy forthe industrial bioeconomy and agricultural/
forestry biomass utilization, stepping up efforts
from province-level initiatives such as Ontario’s
BioProducts strategy132 and BioFuture Alberta.133
France too has world-class research facilities andstrengths in human capital and biotechnology.
France has introduced a range of nationalinnovation laws and policies over the last 20
years to encourage the development andcommercialization of new technologies. These33

3 ZOOMING IN ON THE NEW COUNTRIES SAMPLED IN BUILDING THE BIOECONOMY

biotech crop research.137 Within the context ofagricultural production the Ministry of Agriculture
and government have promoted increased use
and production of ‘bio-based’ products (suchas bio-gas) through a 2017 Bioeconomy Strategy
for France, followed in 2018 by the Bioeconomy
Action plan.138

include the 1999 Law on Innovation and Research(Loi sur l’innovation et la recherche), 2010
Investments for the Future Program (Programmed’Investissements d’Avenir, PIA) as well as thefounding and regulations guiding the French
National Research Agency (l’Agence nationale
de la recherche). Traditionally, French researchand technology creation has been concentrated
in PROs. For the sixth year in a row the French
Alternative Energies and Atomic Energy
Commission (Commissariat à l´énergie atomiqueet aux énergies alternative, CEA) was the top PCTapplicant in the government and public researchorganizations in WIPO’s Patent Cooperation
Treaty Yearly Review 2017, with 329 publishedapplications. Out of top 10 PCT applicants
among government and PROs three came from
France. Looking at biotechnology, the 2017
Medicine of the Future initiative looks at medical
biotechnologies alongside digital solutions andmedical devices to modernize the French medical
industry, as part of the larger Industry of the Futureindustrial transformation plans.134 Other initiatives
include Genomic Medicine France 2025,135 theDigital Health Plan 2020136 and the National
Health Strategy 2018-2022. Like most EU Member
States France has completely outlawed ag-bio
cultivation, citing environmental risks, and restricts

34

Germany has a strong and well-establishedtradition of biotechnological manufacturing andproduct development. As of 2015, Germany had
over 30 ‘bioregions’ – regional biotech clusters
each specializing in a particular area and working
to further collaboration between universities,
research entities and industry. In 2018 the Federal
Cabinet’s Framework Program Health Research
outlined the medical areas considered to havea large unmet need and which should receive
larger government funding over the next ten
years.139 The National Decade of Cancer was
launched at the beginning of 2019 under the
auspices of the Federal Ministry of Education andResearch to advance research into the prevention,
diagnosis and treatment of cancer.140 The crossdepartmental From Biology to Innovation agenda
is set to start in 2019,141 overseen by the Federal
Ministry of Education and Research and theFederal Ministry for Economic Affairs and Energy
in close partnership with business, academia
and civil society.142 There are long-standing
bioeconomy strategies including the National
Bioeconomy Policy Strategy of 2013143 and the 2010
National Research Strategy BioEconomy 2030.
Germany is focusing on strengthening the systemapproach in the bioeconomy, furthering public
private alliances, efficiency in the use of biologicalresources, and public participation.
The Netherlands has a well-established andhigh-quality innovation capacity. Rates of humancapital and general R&D spending are relatively
high at close to 5,000 researchers in R&D per
million population and 2% of GDP, respectively.
There are also high levels of life sciences specificgraduates, comparable to Germany and Israel andhigher than the US. In terms of policy frameworks
the Netherlands has a well-developed nationalinnovation policy including for knowledgetransfer and ‘valorization’ activities. Universities
are encouraged to engage in commercialization
and actively work with industry to develop

BUILDING THE BIOECONOMY 6TH EDITION

new products and technologies. Most major
Dutch universities have functioning technology
transfer offices and well developed programs.
The Netherlands has also introduced a small
business specific technology transfer andcommercialization venture, the Small Business
Innovation Research program. Looking atbiotechnologies the Netherlands has a relatively
advanced biopharmaceutical capacity. The life
science and health clusters account for morethan 2,200 healthcare companies and researchorganizations.144 The life sciences and health sector
is one of nine “top sectors”, designated by the
Dutch Ministry of Economic Affairs.145 A dedicated“Life Sciences & Health” national action programis expected to be launched in 2019.146 As discussed
below in the Annex, like many EU Member States
Dutch health authorities have imposed drastic
cuts in expenditure on mediciens and new
medical technologies. The Dutch government
stopped in 2015 to automatically reimburse new,expensive medicines used in hospitals to instead
add centralized reimbursement negotiations witha capped negotiating time.147 Drugs judged too
expensive for immediate inclusion in the basic
package are included in the “lock for expensive
medicines” (Pakketsluis). Within the “lock period”,
the Ministry of Health negotiates price rebatesfrom manufacturers; drugs are marketed but notreimbursed. Since May 2018 the system applies

to all patented drugs with an annual cost of
EUR50,000 or more per patient. In addition, past
cost containment reforms have transferred highcost in-patient medicines to hospital budgets andcapped hospital budgets’ growth to an annual
rate increase of 1%. While like many other EU
Member States the Dutch have largely outlawed
the cultivation of biotech crops, as a global
leader in plant breeding and seed technology the
Netherlands has been pushing an exemption toexisting EU GMO procedures for so-called “New
Plant Breeding Techniques” which include the useof CRISPR technology in plant breeding. However,a decision of the European Court of Justice (ECJ)risks halting research in this field. On July 25,
2018, the ECJ issued its judgment that organisms
created through genome editing techniques areto be regulated as GE organisms in the EU. The
decision could also limit the ability of the EU
agricultural sector to reduce its environmental
impact and to fight future crop pests and diseases.
The ECJ decision was widely criticized by Dutch
plant breeders.148

35

SECTION

36

BUILDING THE BIOECONOMY 6TH EDITION

4MEASURING POLICY IMPACT AND REAL-WORLD
BIOTECHNOLOGY RESULTS – THE BIOTECHPOLICY PERFORMANCE MEASURE
First featured in 2015 the Biotech Policy Performance Measure (the “Measure”) is anempirical tool that directly compares economies’ policy inputs with real-life biotech
outputs. At essence, this is a way of illustrating the negative impact of short-sighted
and contradictory policy frameworks on real-world biotechnology outputs.
Originally the Measure was solely intended toprovide readers a quick overview of a given
economy’s policy framework and performance inrelation to the other economies included in thereport. It consisted of some of the most importantelements for each of the seven enabling factors
delineated in the Building the Bioeconomy
series. In 2016 the Measure was fundamentally
revamped and significantly expanded to also take
into account biotech outcomes. Indicators on
biotechnology outputs measured cover a broad
spectrum ranging from levels of total clinical trial
activity, biologics clinical trials, scientific output,
GM crops under cultivation, venture capital

attractiveness, biotechnology patenting, rates ofuniversity patenting, biopharma product launches
and so forth.
This year the Measure examines a total of 30
indicators with two new indicators having been
added to this edition of Building the Bioeconomy.
These indicators are divided between 18 measuresof policy inputs (as in previous editions related tothe seven enabling factors) and 12 indicators of
biotechnology outputs. Together they provide arich and detailed measure of the biotechnology
environment for a given economy. As withprevious editions the purpose of the Biotech
Policy Performance Measure is not to benchmark
individual countries to a pre-determined setof criteria; this is not a computational index.
Rather, the purpose is to give readers (and theeconomies mapped) an idea of how a sample oftheir policy inputs (for each enabling factor), firstly,compares with the same policy inputs for the othereconomies sampled and, secondly, what typeof actual biotech outcomes these policy inputs
translate into.

4.1 Policy inputs
The Biotech Policy Performance Measure consistsof two distinct halves: policy inputs and biotech
outputs. Policy input indicators are drawn from theseven enabling factors. These are indicators thatprovide a sense of a given economy’s policies anddirection under each of the enabling factors.
This year there are 18 policy input indicators
measured; two more compared to last year’s
edition. Below Table 3 shows all 18 indicators forthe 7 enabling factors.

37

4 MEASURING POLICY IMPACT AND REAL-WORLD BIOTECHNOLOGY RESULTS – THE BIOTECH POLICY PERFORMANCE MEASURE

TABLE 3 Biotech Policy Performance Measure, policy input indicators
Key enabling factors

Indicators

Human capital• Number of researchers per million population• Life sciences graduates (PhD & Masters), per million population

Infrastructure for R&D• R&D spending % of GDP• BERD spending as a % of total R&D spending• Total biotechnology R&D expenditure, millions USD PPP, per million population• Biotech R&D as a percentage of BERD

Intellectual property
protection• Availability of regulatory data protection for submitted clinical data during theregulatory approval process• Availability of Patent Term Restoration for biopharmaceuticals• US Chamber of Commerce International IP Index 2019 life sciences score, standardized to a %Regulatoryenvironment• Regulatory framework for biopharmaceuticals• Regulatory framework for agricultural biotechnologies

Technology transfer

University/Industry technology transfer framework• Barriers to technology transfer of publicly funded and supported research(US Chamber of Commerce International IP Index 2019 indicator 26 score standardized to a %)• University/Industry Collaboration(World Competitiveness Index Indicator 12.04 score standardized to a %)Private to private licensing framework• Registration and disclosure requirements of licensing deals(US Chamber of Commerce International IP Index 2019 indicator 27 score standardized to a %)• Direct government intervention in setting licensing terms(US Chamber of Commerce International IP Index 2019 indicator 28 score standardized to a %)Market andcommercial incentives• Biopharmaceutical pricing and reimbursement policies

Rule of law• World Justice Project Rule of Law Index 2019 country ranking• Tax incentives for the creation of IP assets(US Chamber of Commerce International IP Index 2019 indicator 30 score standardized to a %)Factor 1: Human capital

Technology’s 2018 International Comparison of
S&T Activities available on the Ministry’s website.

Number of researchers per million population
This indicator estimates the level of technicalcapacity and human resources available withina given country by measuring the number of
researchers in R&D activities standardized
per million population. This indicator is notbiotechnology specific but covers all major formsof scientific and technical fields.149 The data iscollected by the World Bank and forms part of theBank’s World Development Indicators.
This data set includes all of the economies
sampled in Building the Bioeconomy 2019 except
Peru and Saudi Arabia. Equivalent data for Taiwan
was collected from the Ministry of Science and

38

Life sciences graduates (PhD & Masters), permillion population
This indicator compares the number of postgraduate graduates in the life sciences for eachof the sampled economies. This data provides anindication of a given economy’s overall technicalcapacity for advanced R&D activities in the life
sciences. This information is collected by theOECD and forms part of the OECD.Stat databank.
The number of life sciences graduates has beenstandardized for population to provide a moreaccurate reflection of intensity in a given economy
regardless of population size.

BUILDING THE BIOECONOMY 6TH EDITION

This OECD dataset includes all of the economies
sampled in Building the Bioeconomy 2019 except
Algeria, Argentina, Canada, China, Costa Rica,
Ecuador, Egypt, Japan, Kenya, Malaysia, Nigeria,
Peru, Philippines, Saudi Arabia, Singapore, South
Africa, Taiwan, Thailand, the UAE and Vietnam. Data
for Singapore was collected from the Yearbookof Statistics Singapore 2018 published by the
Department of Statistics Singapore. Data
for Taiwan was collected from the Ministry of Scienceand Technology’s 2018 International Comparison of
S&T Activities available on the Ministry’s website.

Total biotechnology R&D expenditure in thebusiness sector, millions USD PPP, per million
population
This indicator measures R&D expenditurein the business sector that is specific to thebiotechnology field. The amount of R&D
investment has been standardized for population
to provide a more accurate reflection of intensity
in a given economy regardless of population
size. The data is collected from the OECD.Stat
databank and forms part of its “Key Biotech
Indicators” measure.

Factor 2: Infrastructure for R&D
R&D spending % of GDP
This indicator measures the investment into R&D
taking place in each economy as a percentageof that economy’s GDP. This indicator is notbiotechnology specific but covers all major
forms of scientific and technical fields.150 The
data is collected from the World Bank World
Development Indicators and OECD.Stat for all
countries covered in the report, except for Saudi
Arabia and Peru for whom data is provided by the
UNESCO Institute for Statistics (UNESCO-UIS).
This dataset includes all of the economies
sampled in Building the Bioeconomy 2019.
BERD spending as a % of total R&D spending
This indicator measures the investment into
R&D taking place by business and private sector
enterprise in each economy as a percentage ofthe total expenditure on R&D. High levels of BERD
suggests a higher propensity for private sector
investment and commitment to innovation andcreating new processes, products and technologies
for commercialization. This indicator is notbiotechnology specific but covers all major forms ofscientific and technical fields. The data is collectedfrom the OECD.Stat databank.
This data set includes all of the economies sampled
in Building the Bioeconomy 2019 except Algeria,
Brazil, Colombia, Costa Rica, Ecuador, Egypt,
India, Indonesia, Kenya, Malaysia, Nigeria, Peru,
Philippines, Saudi Arabia, Thailand, the UAE
and Vietnam.

This data set includes 15 of the economies
sampled in Building the Bioeconomy 2019, namely
Canada, Denmark, Finland, France, Germany,
Ireland, Korea, Lithuania, Mexico, Norway, Russia,
Sweden, Switzerland, Taiwan, and the US. Data for
Taiwan was collected from the Ministry of Scienceand Technology’s 2018 International Comparisonof S&T Activities available on the Ministry’s
website.
Biotech R&D as a percentage of BERD
This indicator measures R&D expenditure specificto the biotechnology field as a percentage ofoverall business enterprise R&D spending. The
data is collected from the OECD.Stat databankand forms part of its “Key Biotech Indicators”
measure.
As for the previous indicator, this data set includes
15 of the economies sampled in Building the
Bioeconomy 2019, namely Canada, Denmark,Finland, France, Germany, Ireland, Korea,
Lithuania, Mexico, Norway, Russia, Sweden,
Switzerland, Taiwan, and the US.

Factor 3: Intellectual property protection
Availability of regulatory data protection for
submitted clinical data during the regulatory
approval processThis indicator measures the availability of
regulatory data protection for submitted clinicaldata during the regulatory approval process.

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4 MEASURING POLICY IMPACT AND REAL-WORLD BIOTECHNOLOGY RESULTS – THE BIOTECH POLICY PERFORMANCE MEASURE

Availability of patent term restoration forbiopharmaceuticals
This indicator measures the availability of a termof patent restoration for biopharmaceuticals due
to delays caused during the sanitary regulatory
review process.

production, cultivation, trials and other research
activities of GE crops, as well as labelling of GE
products. Each economy sampled in Building the
Bioeconomy 2019 is evaluated individually on aqualitative basis.

Factor 5: Technology transfer

US Chamber of Commerce International IP Index
2019 life sciences score, standardized to a %Barriers to technology transfer of publicly funded
and supported researchThis indicator measures the availability andenforcement of IPRs related to the life sciences
sector. This is a composite measure based on an
aggregation of relevant indicators included in theInternational IP Index 2019.

This indicator looks at the existence and extent oftechnology transfer frameworks and operationalarrangements in a given economy that aim tofacilitate the development and commercializationof technologies developed within public sector
entities. It also examines the extent to whichlaws and regulations but also de facto practices
act as barriers to technology transfer andcommercialization activities of publicly funded
and supported research. This indicator is notbiotechnology specific. The data is collected from
“Indicator 26 Barriers to Technology Transfer” in
the U.S. Chamber of Commerce’s International
IP Index 2019. The International IP Index includes
all of the economies sampled in Building the
Bioeconomy 2019 except Denmark, Finland,
Lithuania and Norway.

All three above indicators are drawn from the
US Chamber of Commerce’s International IP
Index 2019.
The International IP Index includes all of theeconomies sampled in Building the Bioeconomy
2019 except Denmark, Finland, Lithuania and
Norway. For these countries, information for the
first two indicators relating to RDP and PTE are
drawn from public legal sources.

Factor 4: Regulatory environment
University/Industry research collaboration
Regulatory framework for biopharmaceuticals
This indicator seeks to measure all aspectsof the regulatory framework in place forbiopharmaceuticals, from product approvaland manufacturing standards to clinicalstandards. This incudes, for instance: the speedof market authorization; patent office backlogs;
bioequivalence requirements for genericproducts; and the existence of a biosimilars
pathway in line with international standards. Eacheconomy sampled in Building the Bioeconomy
2019 is evaluated individually on a qualitative basis.
Regulatory framework for agricultural
biotechnologies
This indicator is based on the existence andefficiency of an ag-bio framework that spells out
a clear, science-based pathway for the adoption
and use of ag-bio products and technologies.
This includes, for instance: rules for the trade,
40

This indicator examines the level of collaboration
between business and universities on R&D, asmeasured by the World Economic Forum Global
Competitiveness Index 2017-2018. The data iscollected from indicator 12.04 “University Industry
Research Collaboration in R&D”, which is notbiotechnology specific. This data set includes
all of the economies sampled in Building the
Bioeconomy 2019 except Taiwan.
Registration and disclosure requirements oflicensing deals
This indicator measures the existence of barriers
to private entity licensing and commercialization
activities in a given economy. In particular, it looks
at the extent to which licensing agreements must
be registered and/or disclosed with relevant
authorities to carry legal effect. The data iscollected from “Indicator 27 Registration anddisclosure requirements of licensing deals” inBUILDING THE BIOECONOMY 6TH EDITION

the U.S. Chamber of Commerce’s International
IP Index 2019. This indicator is not biotechnology
specific. The International IP Index includes
all of the economies sampled in Building the
Bioeconomy 2019 except Denmark, Finland,
Lithuania and Norway.
Direct government intervention in setting
licensing terms
This indicator measures the existence of barriers
to private entity licensing and commercialization
activities in a given economy. More specifically,
it looks at the extent to which the relevant
authorities directly intervene and set licensing
terms between licensee and licensor. This canbe done through, for example, governmental
preapproval for any licensing agreement between
two parties as well as government intervention in
the setting of licensing terms, including royalty
rates. The data is collected from “Indicator 28
Direct government intervention in setting licensing
terms” in the U.S. Chamber of Commerce’s
International IP Index 2019. This indicator is notbiotechnology specific. The International IP Index
includes all of the economies sampled in Building
the Bioeconomy 2019 except Denmark, Finland,
Lithuania and Norway.

Factor 6: Market and commercial incentives
Biopharmaceutical pricing andreimbursement policies
This indicator examines the commercial incentives
provided through existing biopharmaceuticalpricing and reimbursement policies. For thebiopharmaceutical sector market and commercial
incentives are primarily determined by the existingpricing and reimbursement systems for medicinesand health technologies. The manner and extent
to which these policies are put in place canhave a profound impact on the commercial andmarket incentives for innovation more broadly
in the health sector as well as for biotechnology
R&D. Each economy sampled in Building the
Bioeconomy 2019 is evaluated individually on aqualitative basis.

Tax incentives for the creation of IP assets
This indicator examines the tax incentives available
and provided in a given economy as a means ofencouraging R&D. R&D incentives can be various
tax incentives, credits, deductions, lower rates
of taxation for specific forms of income (e.g.
income derived from IP assets such as patent box
schemes) and/or direct support mechanisms suchas grants and subsidies for R&D activities. In somecountries R&D tax incentives are in place thattarget biotechnologies and/or biopharmaceuticalinnovation. Each economy sampled in Building the
Bioeconomy 2019 is evaluated individually on aqualitative basis.
The data is collected from “Indicator 30 Tax
incentives for the creation of IP assets” in the U.S.
Chamber of Commerce’s International IP Index
2019. This indicator is not biotechnology specific.
The International IP Index includes all of theeconomies sampled in Building the Bioeconomy
2019 except Denmark, Finland, Lithuania and
Norway.

Factor 7: Rule of law
World Justice Project Rule of Law Index
country ranking
This indicator examines the legal certainty in agiven economy as measured by the World Justice
Project’s Rule of Law Index 2019. This indicator is
not biotechnology specific. The Rule of Law Index
2019 includes all of the economies sampled in
Building the Bioeconomy 2019 except for Ireland,Israel, Lithuania and Switzerland.

4.2 Biotech outputs
As mentioned, the second half of the Biotech
Policy Performance Measure relates tobiotechnology outputs. Just as with assessing
inputs, measuring biotechnology outputs is adifficult task. There are challenges with bothdefining what constitutes an actual biotech
output as well as finding empirical evidence that iscomparable for all the economies sampled.
This half of the Measure includes 12 indicators intotal described in table 4 below.

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4 MEASURING POLICY IMPACT AND REAL-WORLD BIOTECHNOLOGY RESULTS – THE BIOTECH POLICY PERFORMANCE MEASURE

TABLE 4 Biotech Policy Performance Measure,biotech outputs• Scientific publications per million population• Quality of academic publications• Clinical trials per million population to dateis collected by the World Bank and forms part ofits World Development Indicators. The numberof scientific publications has been standardized
for population to provide a more accurate
reflection of scientific publishing intensity in agiven economy regardless of population size. The
data has also been aggregated and a calculated
average has been used for the period 2003-2016.

• Clinical trials for biologics per million population to date
• Early phase (Phase I and II) clinical trials for biologics, per million
population to date
• Biotechnology triadic patenting, share of global total average 1999-2013• Biopharmaceutical product launches, % available in country within 5 yearsof global product launch, 1983-2000• National % share, total number of patents from top 50 PCT applicants:
universities, 2017
• Biotechnology crops, hectares under cultivation, % of total 2017

This data set includes all of the economies
sampled in Building the Bioeconomy 2019 except
Taiwan. Equivalent data for Taiwan was collectedfrom the Ministry of Science and Technology’s
2018 International Comparison of S&T Activities
available on the Ministry’s website. This datameasures annual papers and rank by nationality in
the SCI ranking.
Indicator 2: Quality of academic publications• Biopharmaceutical Competitiveness Index (BCI) Survey 2017 Ranking• Venture Capital & Private Equity Country Attractiveness Index,
Economy Ranking, 2018
• Biofuels production, % of global total, 2017

As can be seen many of these indicators relate
directly to a given form of biotechnology. These
include, for example, rates of clinical researchon biologic medicines or number of hectares ofbiotechnology crops under cultivation. Other
indicators are more general and not biotechnology
specific. For example, the data for rates of university
patenting is not biotech specific. Still, this measureprovides a good indication of the propensity ofhigher education institutions in a given economy
to seek to patent their technologies. Each of the
12 indicators is described below together with its
source and the number of Building the Bioeconomy
countries that the data set covers.
Indicator 1: Scientific publications standardized
for population
This indicator measures the number of scientificand technical journal articles published from agiven economy.151 This data provides an indicationof a given economy’s overall level of scientific andacademic proficiency and output. This indicator
is not biotechnology specific but covers all major
forms of scientific and technical fields.152 The data

42

This indicator examines the quality of scientificpublications. This data is collected by the OECDand measures the percentage of scientificpublications among the world’s 10% most citedin 2015.153
This data set includes all of the economies
sampled in Building the Bioeconomy 2019 except
Algeria, Argentina, Colombia, Costa Rica, Ecuador,
Egypt, Kenya, Malaysia, Nigeria, Peru, Philippines,
Saudi Arabia, Singapore, Taiwan, Thailand, UAE
and Vietnam.
Indicator 3: Clinical trials per million population
to dateThis indicator provides an overview of thebiopharmaceutical clinical research environment
in a given economy. Specifically, it provides theabsolute number of clinical trials taking place(or having taken place) in a given economy asof April 2019 as collated and registered on thewebsite ClinicalTrials.gov; a website maintained by
the National Library of Medicine at the National
Institutes of Health in the US. As with otherindicators the total number of trials has beenstandardised to population to provide a moreaccurate reflection of levels of clinical researchintensity in a given economy regardless of
population size.

BUILDING THE BIOECONOMY 6TH EDITION

This data set includes all of the economies
sampled in Building the Bioeconomy 2019.

Indicator 6: Biotechnology triadic patenting,share of global total average 1999-2013

Indicator 4: Clinical trials for biologics
per million population to dateThis indicator examines levels of triadic patenting
and an economy’s share of the global number ofbiotechnology patents between 1999-2013. Triadic
patenting is generally considered to be the bestindicator of the perceived overall value and qualityof a patent. The patent application is filed inthree separate locations and filing costs are quite
high. The three major patenting offices in which
protection is sought are: the European Patent
Office, the US Patent Office and the Japanese
Patent Office.

This indicator examines the amount of recent
clinical research focusing on biologic medicines.
Specifically, it provides the number of clinical
trials on biologic medicines taking place (orhaving taken place) in a given economy as ofApril 2019 as collated and registered on thewebsite ClinicalTrials.gov to date. Examining
rates of clinical research specific to biologics isa good indicator of a given economy’s technicalcapacity and proficiency in complex biotech
innovation. Given the size, complexity andinherent instability of a biologic, the R&D process
requires a considerable level of stability andtechnical capacity. The testing of a biologic drugcandidate’s safety and efficacy within a clinical trial
necessitate a highly-controlled environment where
the transportation and storage of the drug arecontrolled, the trial protocols are strictly adhered
to and patients are monitored carefully. As withother indicators the total number of biologic trials
has been standardised to population to provide
a more accurate reflection of levels of biologics
clinical research intensity in a given economy
regardless of population size.
This dataset includes all of the economies
sampled in Building the Bioeconomy 2019.
Indicator 5: Early phase (Phase I and II) clinical
trials for biologics, per million population to dateThis indicator focuses on early phase clinicalresearch on biologic medicines to date (April2019). Early phase trials are the most scientificallyadvanced and represent the most innovativeand riskiest phases of the clinical development
process. As with other indicators the total numberof trials has been standardised to population toprovide a more accurate reflection of levels ofearly phase biologics clinical research intensity in agiven economy regardless of population size.
This dataset includes all of the economies
sampled in Building the Bioeconomy 2019.

This data is collected from the OECD.154 Thisdataset includes all of the economies sampled in
Building the Bioeconomy 2019 except Vietnam.
Indicator 7: Biopharmaceutical product launches,% available in country within 5 years of global
product launch, 1983-2000
This indicator compares relative levels ofbiopharmaceutical product penetration in thesampled economies. Specifically, it looks at thepercentage of products available in a given
economy within five years of first global launch.
The data is drawn from a 2014 National Bureau
of Economic Research working paper and is inturn based on national product approval rates
in 76 individual economies including all of theeconomies sampled in Building the Bioeconomy
2019 except Algeria, China, Kenya, Lithuania,
Nigeria and Vietnam.155
Indicator 8: National % share total numberof patents from top 50 PCT applicants:
universities, 2017
This indicator examines rates of university PCT
patenting as collected and published by WIPO.156
Specifically, it looks at in which countries theworld’s 50 most prolific PCT patenting universities
were based. To obtain a weighted share for eacheconomy included in Building the Bioeconomy
2019 the total number of PCT patents applied forby universities from each economy included in the
top-50 was divided by the total number of patents
applied for in 2017 by all 50 universities.

43

4 MEASURING POLICY IMPACT AND REAL-WORLD BIOTECHNOLOGY RESULTS – THE BIOTECH POLICY PERFORMANCE MEASURE

The underlying data includes all of the economies
sampled in Building the Bioeconomy 2019.
Indicator 9: Biotechnology crops, hectares undercultivation, % of total 2017
This indicator compares levels of biotechnologyderived crops in the sampled economies.157
Data on hectares of biotechnology crops undercultivation are collected by the International
Service for the Acquisition of Agri-biotech
Applications. The number of hectares of biotech
crops under cultivation is a good indicator of
the level of biotechnology derived agricultural
products in a given economy.
This data set includes all of the economies
sampled in Building the Bioeconomy 2019.
Indicator 10: Biopharmaceutical CompetitivenessIndex (BCI) Survey, 2017 Ranking
This indicator compares economy’s relative
attractiveness to biopharmaceutical investment
and innovation as viewed by executives on the
ground in a given economy and captured in the
BCI survey.158 The BCI Survey examines the entire
ecosystem in which biomedical innovation takes
place from scientific capabilities and infrastructure;
to state of the clinical environment; quality andefficiency of biomedical manufacturing andlogistics operations; the biomedical regulatory
framework (including the protection of intellectual
property); healthcare financing; and overallmarket and business conditions. Using statisticalanalysis respondents’ answers are translated
into a quantitative score, which is used tobenchmark economies’ performance and overall
attractiveness for investment. The BCI Survey isconducted by Pugatch Consilium, an international
research consultancy and commissioned by
PhRMA.
This data set includes all of the economies
sampled in Building the Bioeconomy 2019 except
Algeria, Costa Rica, Denmark, Ecuador, Finland,
France, Kenya, Lithuania, Netherlands, Nigeria,
Norway, Peru, Philippines, and Sweden.

44

Indicator 11: Venture Capital & Private
Equity Country Attractiveness Index 2018,
Economy Ranking
This indicator compares economies relative
attractiveness to venture capital and private
equity.159 The Venture Capital & Private Equity
Country Attractiveness Index is compiled by the
IESE and EMLYON business schools and examines
factors from general rates of economic activity
to the taxation environment, investor protection
mechanisms, size and liquidity of existing capital
markets and other relevant factors. Availabilityof venture capital and private equity funding isof considerable importance to biotechnology
innovation and commercialization as manybiotechnologies begin as nascent ideas within astart-up, smaller company or university.
This dataset includes all of the economies
sampled in Building the Bioeconomy 2019 except
for Costa Rica.
Indicator 12: Biofuels production,% of global total, 2017
This indicator measures each country’s percentage
share of the total amount of biofuels produced
globally in 2017. This data is collected from BP’s
Statistical Review of World Energy.
This data set includes all of the economies
sampled in Building the Bioeconomy 2019.

4.3 Green, yellow and red –Traffic light classification system
Each economy’s performance is classified
according to three categories of classification
for both indicators relating to policy inputs andbiotech outputs:
1. Attractive (Policy inputs)/
Highly Competitive (Biotech outputs)
2. Mixed
3. C hallenging (Policy inputs)/
Struggling to compete (Biotech outputs)

BUILDING THE BIOECONOMY 6TH EDITION

Quantitative indicators for both policy inputs
and biotech outputs compare economies to one
another based on relative performance. The
top third of the economy sample is classified
as “Attractive” or “Highly Competitive”. The
middle third of the economy sample is classified
as “Mixed”. And, finally, the lower third of theeconomy sample is classified as “Challenging” or“Struggling to Compete”.
Based on the discussions in previous sections
on the desirability and necessity of each of theseven enabling factors to stimulate innovationin the biotechnology sector, higher levels of themeasured indicators (for instance, R&D spending)translate into a higher classification.
Qualitative indicators are based on a normative
assessment of the desirability of the remaining
enabling factors. For example, for Enabling Factor

3: Intellectual Property Protection, the availabilityof such IPRs as regulatory data protection andpatent term restoration is viewed as attractive.

4.4 The Biotech Policy Performance
Measure – Overall results
Below Figure 2 shows the overall results for the
Biotech Policy Performance Measure. Economies
move from top to bottom in the figure from thoseeconomies that have the most attractive policy
environments and accompanying high levels of
biotechnology outputs to those economies thathave the most challenging environments for both
policy inputs and biotech outputs. (A full set oftables with results for each indicator and inputs
and outputs for each economy is provided in theaccompanying Annex.)45

4 MEASURING POLICY IMPACT AND REAL-WORLD BIOTECHNOLOGY RESULTS – THE BIOTECH POLICY PERFORMANCE MEASURE

FIGURE 2 The Biotech Policy Performance Measure – Overall results
Policy Inputs

Biotech Outputs

US
Denmark
Singapore
Switzerland
SwedenNetherlands
UK
Germany
FranceAustralia
Japan
Finland
Ireland
TaiwanCanadaKorea
Israel
NorwayNew Zealand
Lithuania
Malaysia
China
Chile
Saudi Arabia
Brazil
Costa Rica
UAE
Argentina
TurkeySouth Africa
RussiaMexicoThailand
Colombia
India
Peru
Kenya
Indonesia
Egypt
Philippines
Nigeria
EcuadorVietnam
Algeria
0
46

5

10

15

20

25

30

BUILDING THE BIOECONOMY 6TH EDITION

4.5 The Biotech Policy Performance
Measure – Discussion
As in previous editions of the Measure, datais only partially available for the non-OECD
countries added in 2019. Countries for which data
is incomplete include Algeria, Kenya, Nigeria,
Vietnam and to a lesser extent Costa Rica and
Lithuania; the latter of which only recently joined
the OECD. Reliable, standardized data is a precondition for successful biotech policy-making.
It allows researchers and policymakers to get
as accurate and in-depth understanding of
the strengths and weaknesses of the national
biotech system, assessing the effectiveness ofdifferent policies in achieving stated objectives.
In this sense, data shortages resonate both as anindicator and a consequence of a low-prioritized
innovation system.
Looking at the available indicators, the addition of
11 new economies (a growth of 33% in the samplesize) strengthens the overall message of previous
editions of the Measure: Inputs equal outputs.
There is a link between creating a positive
enabling environment with real-world biotech
outcomes.
Economies that have weak enabling
environments– and perform worse relative toother economies on the indicators relating
to policy inputs – tend also to have lower
biotechnology outputs. Adopting a pragmatic,
long-term approach focused on getting the policy
environment right is key to reaping the economic
and social benefit of biotechnologies.

economies with limited natural resources such as
Israel, Denmark, Ireland and Singapore have torely more on ingenuity, creativity and getting the
incentives right to create an enabling environment.
Most countries have recognized the need ofmoving to or further strengthening the knowledge
economy as a basis for long-term growth anddevelopment. To achieve this, many have set
the objective of increasing R&D spending
and research capacities. Human capital andan appropriate quality of R&D infrastructure
are key to innovate or even take advantage oftechnological advances abroad. They are also a
pre-requisite to effective knowledge transfer. As
mentioned above, many countries are asserting
their biotech ambition through a biotech hub,techno park or even a designated city as a flagshipproject. Yet, while the stated ambitions are there,
only 14 out of the 44 countries sampled spend
more than 2% of their GDP on R&D. As noted inlast year’s edition, while there is a link between
the level of GDP (and economic structure) andR&D spending, there are also important variations
based on individual countries’ policy choices. For
instance, Norway and China both basically spend
between 2.1% of GDP on R&D activities, although
Norway has a GDP per capita almost four times
higher than China measured on a PPP basis.

Another important take-away from the Measure isthat there is no shortcut to building a conducive
biotech policy environment. Each economy
has its own strengths, which it can leverage
to enhance its attractiveness vis-à-vis othermarkets. Some – such as many Latin Americancountries – are blessed with rich and varied
ecosystems that provide a strong starting point
for biotechnological innovation and R&D. Others– such as Algeria, Nigeria and Norway – havebenefitted from the inflow of revenues fromnatural resources. Relying only on the strengths
cannot – alone – deliver the expected economic
and social benefits of biotechnologies. Small

47

SECTION

48

BUILDING THE BIOECONOMY 6TH EDITION

5FINAL THOUGHTS AND RECOMMENDATIONSAs discussed in Section 1 biotechnology has emerged as one of the maintechnological solutions for today’s health, food and environmental needs. But to agreater or lesser degree all biotechnologies need policy support and depend on
government actions.
Health biotechnology is a highly regulated sector
that strongly depends on governments as its
main buyer and on government policies formarket access.
Similarly, government’s policy decisions
have closed off entire markets to agricultural
biotechnologies.
And in the case of industrial biotechnologies,
incentives and government support are often
crucial to developing and enabling thecommercial distribution and mass consumptionof these products.
For six years, this report has reflected on how
the right policies can help build thriving biotech
sectors. This edition of Building the Bioeconomy
again makes it clear that the countries thatstand the best chance of enjoying the fruits ofbiotechnology innovation are the ones where
forward-looking regulations act to encourage, andnot hinder, innovation.
Based on the analysis and mapping of the nationalinnovation systems and biotechnology policies
and enabling factors in place in the 44 countries
sampled it is possible to piece together five
universal recommendations. They are:
1. C reate a national blueprint or plan of action– The existence and creation of a blueprint
or national biotechnology strategy can be a
powerful tool in creating a vision and setting
a goal for national aspirations. There aremany ways in which governments can provide
leadership and direction for the building of
a biotechnology capacity. By and large mostcountries studied in this paper have directly
or indirectly targeted biotechnology as atechnology and industry of strategic importanceto national economic development and growth.

But not all 44 of the sampled countries had
developed national blueprints or pans fordeveloping the sector.
2. E xecute – A national blue print or plan of action
is a necessary starting point for all aspiring
biotech nations, but it is only the first step.
Once it has been formulated and drawn up it
must be implemented. Building a bioeconomy
is not a short-term proposition. It takes longterm planning, patience and commitment. But
where many countries fall short is in their ability
and efforts to move from a planning phaseto actually implementing and applying thenecessary policies. This is where the hard work
begins.
3. M easure performance – The measuringof performance and the creation of key
performance indicators is critical. Without anunderstanding of whether or not implemented
policies are actually working it is impossible toproperly evaluate whether any progress is being
made.
4. R
 ecognize and use existing best practices –Although no two countries are the same and allface different circumstances, countries can learn
from the experiences of each other.
5. Leverage national capabilities – Understanding
and focusing on one’s comparative andcompetitive advantage can lead to the mosteffective allocation of resources. Country size,
scientific and research strengths, geography
and biodiversity are all important attributes.
Some countries have natural strengths in somebiotech sectors whereas others can competeand develop across the board.

49

NOTES	https://sustainabledevelopment.un.org/post2015/transformingourworld1

30

	https://www.academia.edu/35199386/Biotechnology_for_
Sustainability_Achievements_Challenges_and_Perspectives

2	https://www.oecd.org/science/emerging-tech/1947629.pdf

3	Pugatch Consilium (2014-17), Building the Economy - Examining
National Biotechnology Industry Development Strategies report.
Commissioned by the Biotechnology Industry Organization andauthored by Pugatch Consilium, this series of reports provides an
overview of those national innovation strategies, policies and bestpractices that have been successful in creating an environment
in which biotechnologies and biotechnological innovation canflourish.

	OECD Health Statistics 2017 - Frequently Requested Data, Current
expenditure on pharmaceuticals (prescribed and over-thecounter medicines) and other medical non-durables, % of current
expenditure on health, June 201731

4	Bloomberg (2018) “China Opens a ‘Pandora’s Box’ of Human
Genetic Engineering”, Bloomberg News, November 27 2018.

32

	IMS Health (2014) Global Outlook for Medicines Through 2018 p. 24

33

	https://www.uschamber.com/sites/default/files/190222_memo_
internationalpricingindex_congress.pdf

34

5

	Ibid.

	http://www.phrma-jp.org/wordpress/wp-content/uploads/2018/01/
slide20180129_en.pdf
	https://mapbiopharma.com/2019/03/concerns-about-japans-newhta-process/36

	WTO (2018) World Trade Statistical Review 2018, p. 71.

8

	R. Atkinson et al. (2012), “Hearing on the Impact of Technology
Transfer on American R&D”, 12/05/2012

9

10
11

	Deloitte (2014), p.10

	Ibid.
	USDA (2013), “Agricultural Biotechnology Annual - China”, Report
13033, pp. 6-8

	https://www.ohe.org/news/hta-japan-failing-meet-internationalgood-practice37

	Ibid., pp. 41-43, 160-161.

38

	https://www.canada.ca/en/health-canada/programs/consultationregulations-patented-medicine/document.html

39

12

13

	http://www.pdci.ca/wp-content/uploads/2018/02/18-02-14Janssen-PMR-CG1.pdf

40

	Ibid. p. 13.

41

	Ibid.

42	http://www.koreaherald.com/view.php?ud=20190218000535

14

15

17

	The Korea Times (2015), “Foreign Drug Firms Call for Easing Rules
on Pricing, Reimbursement”, 02/27/2015, “http://www.koreatimes.
co.kr/www/news/biz/2015/02/123_173777.html; KRPIA (2015),“Pharmaceutical Industry Raises Voice for Frequent System for
Reducing Drug Prices”, Press Release, 05/06/2015, http://members.
krpia.or.kr/bbs/bbs_view.asp?num=12978&bd_gubun=04

	Informa Agribusiness Consulting (2018) The Impact of Delays in
Chinese Approvals of Biotech Crops, May 2018, pp. 9-10.

16	Ibid.

	Ibid., p.36.

18

	SFDA Annual Drug Review Report 2014 (translated), http://www.
sfda.gov.cn/WS01/CL0108/125301.html

43	International Law Office (2015), “Biosimilars are Regulated
Differently in China”, 07/22/2015, http://www.internationallawoffice.
com/Newsletters/Detail.aspx?g=57994138-d11b-49f3-b2d70590061421ad&redir=11920	https://www.morganlewis.com/pubs/china-national-drugadministration-sets-guidelines-for-overseas-drug-trial-data	Ministry of Health, Labor and Welfare, Official Notification, Mar.
5, 2018;see also https://healthpolicy.pharma.bayer.com/risingconcerns-for-pharmaceutical-innovation-in-japan/

35	World Bank, databank, GDP (current US$)

6
7

	DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for
Medicare & Medicaid Services 42 CFR CHAPTER IV, [CMS-5528ANPRM], RIN 0938-AT91, Medicare Program; International Pricing
Index Model for Medicare Part B Drugs, p. 44.

	IHS (2012),”Pharmaceutical Price Cuts in South Korea in 2013”,
12/27/2012, http://blog.ihs.com/pharmaceutical-price-cuts-insouth-korea-in-2013; Pharma (2015), “301 Special Submission
Revue,” p. 67-68; EC/DG TRADE Market Access Database,“Pricing of Pharmaceutical and Medical Devices – Korea”,
http://madb.europa.eu/madb/barriers_details.htm?barrier_
id=135438&version=1

44

	Draft National People’s Congress (NPC) amendment to the Drug
Administration Law (DAL) (November 2018); see http://www.pmlive.
com/pharma_intelligence/Chinas_clinical_trial_shake-up_1274617

21

	Review and Approval Procedures for Urgently-Needed
Pharmaceutical Drugs Developed Overseas, published on October30, 2018 (the Procedures).

2223

	https://www.morganlewis.com/pubs/china-creates-specialchannel-for-fast-track-approval-of-some-foreign-drugs

	https://www.fiercepharma.com/pharma-asia/china-offers-raredisease-drugs-preferential-tax-rate-latest-bid-to-spur-introduction	Ibid.

45	National Health Insurance Service . Policy Report: A Study on the
Introduction of Risk Sharing Contract. National Health Insurance
Service; SeJong, Korea: 2012; as reported in https://www.ncbi.nlm.
nih.gov/pmc/articles/PMC6352121/#B29-ijerph-16-00288

46

24

	This refers to OECD conclusions under Action 8 of the BEPS action
plan, which advocated for the implementation of the so-called“nexus” approach, which correlates the benefit of the reduced tax
rate applicable to profits derived from licensing, sublicensing, or
selling patents and like assets to R&D expenses borne to create
them. See for example proposed reforms in France https://mnetax.
com/frances-2019-draft-finance-bill-adds-new-rules-for-patentboxes-interest-deductions-tax-consolidation-30067

47

25

26

	https://www.ey.com/Publication/vwLUAssets/ey-worldwiderd-incentives-reference-guide-2018/$FILE/ey-worldwide-rdincentives-reference-guide-2018.pdf

27	https://www.callaghaninnovation.govt.nz/grants/rd-tax-incentive;
https://www2.deloitte.com/nz/en/pages/tax-alerts/articles/
government-announces-r-and-d-tax-incentive-scheme-details.html

48	http://members.krpia.or.kr/bbs/bbs_view.asp?num=16344&bd_
gubun=04Chung Dong-s/FNN news (2016), “Why do we need toreconsider our selection criteria?”
11/18/2016, http://www.fnnews.com/news/201611181338596172

	KDRA (2016), “Overview of KDRA, KHIDI and Korean
Pharmaceutical Market”, http://www.kdra.or.kr/image/2016/3.%20
Overview%20of%20KDRA,%20KHIDI%20and%20Korean%20
Pharmaceutical%20Industry(2016).pdf

49	https://fas.org/sgp/crs/row/IF10733.pdf

5051

	PhRMA 201952

	https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/globaloutlook-for-medicines-through-2021.pdf?la=en&hash=6EA26BACA
0F1D81EA93A74C50FF60214044C1DAB

53

29

50

	Yoon&Yang/Lexology (2016), “Expected Implementation of Reform
Plan for Biopharmaceutical Price System”, 7/14/2016, http://www.
lexology.com/library/detail.aspx?g=51a596b1-ae38-4f79-b5cb8b1dd307f2e4

	https://www.handelsblatt.com/today/politics/innovation-leg-upgermany-plans-first-rundd-tax-breaks/23582808.html?ticket=ST2211145-7NjiJHczNSXb6yKbpzCZ-ap1

28

	This system is complemented by other measures including rebates
associated with price-volume agreements. Moreover, inclusion
for reimbursement is dually determined by a ruling of costeffectiveness by the Health Insurance Review and Assessment
Service and price negotiations with the National Health Insurance
Corporation.

	Turkish Medicine and Medical Device Agency -TITCK (2016),“Announcement about the Localization Process”, http://www.titck.
gov.tr/Duyurular/DuyuruGetir?id=2521
	https://www.dailysabah.com/technology/2018/09/25/turkey-topromote-biotech-to-claim-larger-share-of-140b-global-market

BUILDING THE BIOECONOMY 6TH EDITION

54

55

	“Presidency Decision No. 108 on the New Economy Program forthe period 2019- 2021” of 20 September 2018, in particular Part 4(Current Account Deficit) and 7 (Programs and Projects – Health)	http://europa.eu/rapid/press-release_IP-19-1952_en.htm http://
trade.ec.europa.eu/doclib/docs/2019/april/tradoc_157821.pdf
	M Pugatch et al (2012), Taking Stock: How Global Biotechnology
Benefits from Intellectual Property Rights, The contribution of
IPRs to the biotechnology ecosystem and economic growth indeveloped and emerging economies: examining the literature andevidence, BIO 2012.

56

57

	http://www.europarl.europa.eu/RegData/commissions/juri/
inag/2019/02-20/JURI_AG(2019)637374_EN.pdf

	PhRMA (2014), “Press Release – Global Biopharmaceutical Industry
Signs New Policy Partnership Agreement with government of
Algeria to Develop Innovative Medicines”, http://www.phrma.org/
press-release/global-biopharmaceutical-industry-signs-new-policypartnership-agreement-with-government-of-algeria-to-developinnovative-medicines-sector

8182	Government Action Plan, p.46. See also Government Action Plan for
Implementing the Presidential Program, June 2017, text available
at https://www.tsa-algerie.com/wp-content/uploads/2017/06/
img20170615_15453810.pdf
	Huffington Post Algeria (2016),‘The Biotechnology Park of Sidi
Abdellah will Attract more than 12 billion USD Investment”,
3/24/2016, http://www.huffpostmaghreb.com/2016/03/24/polebiotech-abdellah_n_9537640.html; Algerie Patriotique (2012),“Biotech Development Strategy presented at the BIO Convention
in Boston” (translated), 06/20/2012, http://www.algeriepatriotique.
com/article/la-strategie-de-developpement-de-la-biotechnologieen-algerie-presentee-la-convention-intern83	Figures from the European Federation of Pharmaceutical Industries
and Associations show that in 2015 the European research-basedindustry provided nearly 740,000 direct jobs (with over 113,000 in
high-skill R&D jobs), over EUR33.5 billion in R&D investments, andover EUR238 billion in production in 2015 alone.

58

	https://www.lifesciencesipreview.com/news/indian-court-clearsexport-of-patented-bayer-drugs-for-research-3481

59	https://news.bloomberglaw.com/pharma-and-life-sciences/bayerloses-case-in-india-on-generic-cos-exporting-drugs-for-r-d?utm_
source=rss&utm_medium=HPNW&utm_campaign=0000016a458c-dcde-a1fe-efdfb141000084

60	http://www.mondaq.com/china/x/781174/Patent/Highlights+Of+Th
e+Draft+4th+Amendment+To+The+Patent+Law+Published+On+J
anuary+4+2019

61	https://f.datasrvr.com/fr1/519/28018/China_issues_its_fourth_draft_patent_law_after_over_three_years_of_deliberation_18_
January_2019____.pdf; text available in Chinese at https://
npcobserver.files.wordpress.com/2019/01/patent-law-draftamendment.pdf

6263	https://www.hlregulation.com/2019/01/09/pharma-may-benefitproposed-patent-law-changes-china/	https://f.datasrvr.com/fr1/519/28018/China_issues_its_fourth_draft_patent_law_after_over_three_years_of_deliberation_18_
January_2019____.pdf

	Ministry of Trade website, “Import of Drugs in the First 11 monthsof 2017”, 1/11/2017, https://www.commerce.gov.dz/statistiques/
importation-medicaments-durant-les-11-mois-201685	https://www.nacosti.go.ke/#8687	https://vision2030.go.ke/	http://real.mtak.hu/78346/1/Kivuva_Columella_
vol4no22017_47_54_u.pdf

89	https://biooekonomie.de/en/bioeconomy-kenya

90
91	https://www.nacosti.go.ke/images/docs/2018/november/news/
DRAFT%20ST&I%20POLICY.pdf

92

93

65

	http://www.conventuslaw.com/report/china-drug-administrationpublishes-a-key-draft/;

66

67	http://workspace.unpan.org/sites/internet/Documents/
UNPAN048879.pdf

	http://innovationnigeria.com/2018/11/08/nigeria-economy-andindustrialization-challanges-nstir-2030-to-the-rescue/	The Council brings together all Ministers and representativesof industry asssociations to foster growth of innovationbased entrepreneurship and create the conditions for thecommercialisation of public research http://nass.gov.ng/document/
download/8317

94	https://www.chinaiplegalreport.com/2018/08/china-plans-increasemarket-exclusivity-term-pharmaceuticals-based-improvedpharmaceutical-trial-data-protection/95

	https://www.bloomberg.com/news/articles/2019-04-25/u-s-said-tomull-concessions-on-drug-protections-in-china-talks

97

68

https://big4.president.go.ke/

8864	https://f.datasrvr.com/fr1/317/96045/BEILIB01-89760-v1-Major_IP_
reforms_foreshadowed_in_China_s_Pharma_sector_.pdf

	https://www.lemonde.fr/afrique/article/2018/10/12/en-algeriesanofi-inaugure-le-plus-grand-complexe-pharmaceutique-dafrique_5368323_3212.html

	https://techpoint.africa/2018/07/10/tech-creativity-advisory-group/	https://nabda.gov.ng/

96	https://nabda.gov.ng/about-us/	https://www.nafdac.gov.ng/nafdacs-communications-to-theindustry-03191/

	Hussain I. (2012) NAFTA and Intellectual Property Rights. In:
Reevaluating NAFTA, p. 83, Palgrave Macmillan, New York

98

	Pugatch, M. P. (2004), The International Political Economy ofIntellectual Property Rights, pp. 129, 131; ICTSD, WHO, UNCTAD(2006), Guidelines for the Examination of Pharmaceutical Patents:
Developing a Public Health Perspective – A Working Paper, p. vii.

99

	https://www.researchgate.net/publication/324330726_
PROCESSUS_D’EMERGENCE_D’UN_CLUSTER_
BIOTECHNOLOGIE_CAS_DE_SIDI-ABDALLAH_EN_ALGERIE_
ALGER

101

	https://www.konzacity.go.ke/

102	https://www.yachay.gob.ec/empresas/

103

69

70

71

72

73

	https://news.mb.com.ph/2019/01/24/philippine-innovation-actapproaches-approval/

100	http://manilastandard.net/news/national/270738/fda-totake-drastic-moves-to-ease-backlogs-.html; https://www.
pacificbridgemedical.com/news-brief/philippines-authoritiesrushing-to-clear-product-approval-backlogs/

	NAFDAC, NAFDAC website, Communication to the Industry, Five
Plus Five-Year Validity (Migration* to Local Production**), May 2019.

74

75

76

	https://www.nafdac.gov.ng/nafdacs-communications-to-theindustry-03191/

	Ibid.
	https://www.fas.usda.gov/data/kenya-agricultural-biotechnologyannual-2	https://allianceforscience.cornell.edu/blog/2018/07/nigeriacommercializes-bt-cotton-first-gmo-crop/	https://isaaa.org/resources/publications/communication_
challenges_and_convergence_in_crop_biotechnology/download/
communication_challenges_and_convergence_in_crop_
biotechnology-chapter3.pdf

105	http://radioalgerie.dz/news/fr/article/20180506/140743.html

80

107

	https://www.vicepresidencia.gob.ec/objetivo-general-objetivosestrategicos-y-entorno-para-el-cambio-2/.

	https://www.gobiernoelectronico.gob.ec/wp-content/uploads/
downloads/2017/09/Plan-Nacional-para-el-Buen-Vivir-2017-2021.
pdf

106

79

	Remouche Khaled/Liberte Algerie (2016), “Development of the
Biopharmaceutical Industry Handicapped by Bureaucracy”,
2/1/2016, https://www.liberte-algerie.com/actualite/ledeveloppement-de-lindustrie-pharmaceutique-handicape-par-labureaucratie-241296

	http://biotech.da.gov.ph/

104

77

78

	https://www.opengovasia.com/twin-innovation-bills-to-benefitphilippine-start-ups-and-msmes/

	https://ec.europa.eu/jrc/en/publication/territorial-growth-ecuadorrole-economic-sectors-0; http://www.ecuadorencifras.gob.ec/
encuesta-nacional-de-actividades-de-ciencia-tecnologia-einnovacion-acti/	https://www.canada.ca/en/health-canada/services/scienceresearch/emerging-technology/biotechnology/role/canadabiotechnology-strategy.html

51

NOTES108

143

	https://www.bmel.de/SharedDocs/Downloads/EN/Publications/
NatPolicyStrategyBioeconomy.pdf?__blob=publicationFile	https://www.ic.gc.ca/eic/site/093.nsf/eng/00012.html

144	https://lifesciencesbaltics.com/allnews/

145

	https://lifesciencesbaltics.com/allnews/

146

109
110
111

	file:///C:/Users/danigritti/Downloads/agricultural-innovationclusters-in-canada.pdf

114
113

	https://lifesciencesbaltics.com/allnews/

115

	http://www.prweb.com/releases/dupont-pioneer-seed/patentvilnius-crispr-cas/prweb14297888.htm

116

117

	https://www.health-holland.com/news/2019/03/nationaalactieprogramma-lsh	Ibid.

	http://eimin.lrv.lt/en/news/minister-of-economy-sinkeviciuslithuania-has-to-focus-on-the-biotechnology-sector

114

	Ibid.

	https://www.tfhc.nl/the-netherlands/

	http://haiweb.org/publication/new-and-affordable-medicines-inthe-netherlands/

147

	JO Gakpo (2018) “The Netherlands: EU ruling on new breeding
techniques could harm exports”, Cornell Alliance for Science,
October 2 2018.

148

	The World Bank describes this indicator as: “Researchers in R&D
are professionals engaged in the conception or creation of new
knowledge, products, processes, methods, or systems and in
the management of the projects concerned. Postgraduate PhD
students (ISCED97 level 6) engaged in R&D are included.”149

	https://ec.europa.eu/regional_policy/en/projects/lithuania/lifesciences-centre-in-lithuania-provides-exciting-opportunities-forstudents-and-researchers	https://ssmtp.lt/

118

119

	https://www.triplehelixassociation.org/helice/volume-5-2016/helice-issue-5-2/management-and-implementation-of-technologytransfer-the-case-of-sunrise-valley	Through for instance the Long-Term Plan for Research and Higher
Education 2015-2024 https://www.regjeringen.no/en/dokumenter/meld.-st.-7-2014-2015/id2005541/
https://www.regjeringen.no/en/dokumenter/national-strategy-forbiotechnology/id666235/
	https://www.regjeringen.no/contentassets/5b2dc02e8dd047adba1
38d7aa8b4dcc1/nfd_biookonomi_strategi_engelsk_uu.pdf

120

150

151

	World Bank, World Development Indicators, Scientific and technicaljournal articles, Accessed May 2018.

152	https://www.biofuelsdigest.com/bdigest/2018/12/09/norway-firstcountry-to-ban-biofuel-from-palm-oil/

121	https://www.greencarcongress.com/2018/10/20181009-norway.html

122	https://www.norden.lv/Uploads/2017/01/17/1484641643_.pdf

123	World Bank defines the fields covered as: “Scientific and technicaljournal articles refer to the number of scientific and engineering
articles published in the following fields: physics, biology,
chemistry, mathematics, clinical medicine, biomedical research,engineering and technology, and earth and space sciences.”153	https://www.regjeringen.no/en/dokumenter/gene-technology-act/
id173031/124	https://www.ic.gc.ca/eic/site/062.nsf/vwapj/InnovationNation_
Report-EN.pdf/$file/InnovationNation_Report-EN.pdf

125	https://www.ic.gc.ca/eic/site/062.nsf/vwapj/ISEDC_19-044_
INNOVATION-SKILLS_E_web.pdf/$file/ISEDC_19-044_
INNOVATION-SKILLS_E_web.pdf

	The World Bank describes this indicator as: “Expenditures forresearch and development are current and capital expenditures(both public and private) on creative work undertaken
systematically to increase knowledge, including knowledge ofhumanity, culture, and society, and the use of knowledge for new
applications. R&D covers basic research, applied research, andexperimental development.”	OECD (2017), “OECD Science, Technology and Industry Scoreboard
2017”, Chapter 3, Graph 3.1.1. Quantity and quality of scientificproduction, 2005 and 2015.

154

126

	https://www.ic.gc.ca/eic/site/098.nsf/eng/h_00020.html

155

127

	Iain M. Cockburn, Jean O. Lanjouw, Mark Schankerman (2014)“Patents and the Global Diffusion of New Drugs”, NBER Working
Paper No. 20492, Table A2, p. 43.

156

	See above canada price increase128	https://www.ic.gc.ca/eic/site/098.nsf/eng/00016.html

157	https://ppforum.ca/publications/bringing-innovation-lifeinnovation-based-growth-canadian-life-sciences/

158

129

130

131

	https://ppforum.ca/publications/bringing-innovation-lifeinnovation-based-growth-canadian-life-sciences/132

	http://www.omafra.gov.on.ca/english/crops/bioproducts/
bioproducts.html

133	https://albertainnovates.ca/funding-alberta-bio-future/

134

135

	https://solidarites-sante.gouv.fr/IMG/pdf/genomic_medicine_france_2025.pdf

136

137

	https://www.gouvernement.fr/action/la-nouvelle-franceindustrielle; https://danielbenamouzig.files.wordpress.
com/2017/04/20170426_mecc81decine-du-futur-4.pdf

	https://www.ars.sante.fr/la-strategie-nationale-e-sante-2020;
http://www.france-biotech.fr/wp-content/uploads/2018/12/CP_
Panorama_2018_FR.pdf

	https://www.reuters.com/article/us-france-gmo-bayer/frenchgerman-farmers-destroy-crops-after-gmos-found-in-bayer-seedsidUSKCN1PV1RG

138

139

	https://agriculture.gouv.fr/bioeconomy-strategy-france-2018-2020action-plan

	https://www.bmbf.de/de/forschen-fuer-ein-gesundes-leben-7441.
html
	https://www.bmbf.de/de/startschuss-der-nationalen-dekadegegen-krebs-7755.html; https://www.vfa.de/de/presse/pressemitteilungen/pm-004-2019-krebs-den-schrecken-nehmeneine-gesamtgesellschaftliche-aufgabe.html

140	https://www.biodeutschland.org/de/pressemitteilungen/agendavon-der-biologie-zur-innovation-jetzt-zuegig-einfuehren.html

141	https://www.biodeutschland.org/de/positionspapiere/
handreichung-fuer-eine-ressortuebergreifende-agenda-von-derbiologie-zur-innovation-biotechnologie-agenda.html

142

52

159

	OECDStat, Patents by technology, Triadic Patent families,
Biotechnology, Inventor’s country of residence, Priority date, 19992013.

	WIPO (2018), “Patent Cooperation Treaty Yearly Review”, Top 50
PCT applicants: universities, 2017.

	James, Clive (2017), “Global Status of Commercialized Biotech/GM
Crops: 2016”, ISAAA, Brief No. 52. ISAAA, Ithaca, NY.
	Pugatch Consilium (2017) “Ascending to the Peak ofBiopharmaceutical Innovation - The Biopharmaceutical Investment& Competitiveness (BCI) Survey – 2017”, October 2017, http://www.
pugatch-consilium.com/reports/BCI_2017_Report.pdf

	A Groh et al. (2018), “Venture Capital & Private Equity Country
Attractiveness Index 2018”, IESE and EMLYON, https://blog.iese.
edu/vcpeindex/

BUILDING THE BIOECONOMY 6TH EDITION

53

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