Sustainability health and innovation
Lecture 1: Introduction Sustainability, Health & Innovation – Ellen Moors
There are millennial development goals which are very limited, and which focus more on public
sectors, poverty, and public health. Sustainable development goals focus more on private sectors and
the goals are more comprehensive. There are 17 SDG’s. here, each goal is important which is the
focus of the course, but they keep being connected. We focus mainly on SDG-3, SDG-10, and SDG-
13. The focus is on life sciences, health and ageing, medical devices, healthy foods, and healthy urban
living.
Innovation in life sciences and health is science-driven with a high attrition-rate. The development
times are normally extensive for products, normally because for the vaccinations this was not the case.
There is a dominance of patents, which high R&D costs. It is very regulated which is different from
other industries such as that you need approvals, reimbursement by health authorities all additional
steps to get new products on the market. Moreover, there is not much choice for patients there are 3
vaccines. The patient is not in a powerful position which is different from other industries.
The pharmaceutical industry is in a crisis where there is a focus on orphan drugs, more drugs lead to
unknown diseased with insufficient data. It is also interesting to focus on cancer as they are expensive.
The number of drugs without efficacy is increasing and the number of pharmaceutical and
biotechnology companies are decreasing. The cause of the crisis is because of all drug regulations,
they are more and more dependent on research institutes and the role of academia is changing. Barriers
in innovation systems is that new products are expensive, less effective which leads to inequalities
locally, nationally, and world-wide regarding availability, affordability, access, and the safety/quality
of essential medicines. The current drug innovation system is not sustainable anymore, the question is
how to make it more sustainable by understanding the 5 qualities of drug development:
1. Available
2. Affordable
3. Accessible
4. Acceptable
5. Safe
Price controls, reference pricing, pharmaco-economic evaluation, negotiated prices and central
purchase are terms that can be used for a transition to sustainable drug development. You can also
think about reimbursement cap, pay-for-cure, or other distributed drug innovation models. All these
aspects are a way to deal with prices in the drug development. There are some possible strategies like:
- Through the legal system
o Via patent legislation
o Via abolishment data protection by regulatory authorities
o Via Eu legislation against cartels
o Via Human Right Legislation
- Following a non-profit approach by using alternative drug development models. It is to gain a
better image. Magistral production is a new way to develop drugs which is used more in the
Netherlands.
New models of sustainable drug development focus on the four A’s and the S.
Drug development model
There is a model for drug development where there are 5 main stages. They are central and then there
are several steps where there could be bottlenecks. In the clinical phase there are 3 stages, the fourth
stage is the post marketing surveillance stage. Drug discovery is about a disease to be treated or
prevented where you need a target which is expected to do something. Drugs need to be syntheses in a
chemical or biological way, the last one is more difficult. It is important to look for that molecule with
the best properties. First, you characterize the molecule (in vitro phase). Then we go to testing phase to
,test how toxic and effective it is for animals (in vivo phase). Many of the biological medicines tested
on mouses are not representative for humans because they are very complex. Chemical compounds are
more generally applicable. Clinical phase 1 is already in the human, often with volunteers to
experiment. They test the kinetics, does it work? And the dynamics, where does it work? If that works,
we have the proof of concept where you find out whether the medicine is working like expected. For
covid, we stopped between phase 1 and phase 2. For phase 3 we need placebo and time to test the
medicine on a lot of people. Then you go to the EMA to get the drug approved which is after about 12-
15 years. You end up with one approved drug. The failure of the medicine depends on the type of
disease. The overall success rate is around 11%.
After approval you need to show the safety over time in reports, then you can work on label extensions
(later vaccinate 18- instead of only 18+), then we have the reimbursement and the discussion of the
pricing. Reimbursement is very important as it must be affordable to be effective for people.
Different actors have different wishes such as the industry, patient groups, payers, and the
media/scientific community. Some groups are working to a shorter timeline while others want more
studies/patients.
Article Atun: Health systems, system thinking and innovation
Lessons emerging from instances of low innovation adoption suggest that when addressing health
problems, reductionist and linear approaches that provide technical solutions alone are not adequate to
mount effective responses, as the adoption and diffusion of innovations which underpin responses to
health problems are influenced by complex health systems, the
socio-political context within which the health systems are embedded and the innovation adoption
system.
Multiple interacting factors influence adoption of innovations, ranging from new technologies, to
novel service delivery models and to health policies. Therefore, a broader and more sophisticated
analysis of the context, health system elements, institutions, adoption systems, problem perception and
the innovation characteristics within these will enable better understanding of the short- and long-term
effects of an innovation when introduced into health systems. A simplistic situational analysis may
result in barriers and enablers to innovation adoption being overlooked, and risk unforeseen
consequences and policy resistance. One way to reduce this policy resistance is to adopt systems
thinking to look at all interacting elements within the complex adaptive health systems in a holistic
manner to devise effective responses.
Combining technological innovations with other innovations in health systems (such as innovative
approaches to governance, financing, service delivery, awareness creation and demand mobilization)
enables effective adoption of innovations in health systems.
Systems thinking can help understanding of the dynamic complexity that characterizes complex
adaptive systems. The dynamic complexity which emerges from bidirectional inter- action among
innovations, entities adopting innovations, institutions, health systems, and the context in which health
systems are embedded will need to be understood to help devise policies and tactics to enable effective
adoption and diffusion of innovations in health. While health systems as adaptive systems are
complex, their understanding informed by systems thinking need not be complicated.
,Lecture 2: Innovation systems – Ellen Moors
The 4 As are affordability, availability, acceptability, and accessibility. They can help to show
challenges within scopes. A problem can occur because of policy problems, management issues or
research puzzles. With the help of research and theory, you can operationalize the problem. Health-
related innovation needs to be part of the paper, therapy, diagnostic device or medical technology or
prevention procedure. The 5 steps for analyzing a technological
innovation system are:
1. Structural analysis
a. Components: Actors, institutions, networks,
infrastructure & technological factors
2. Phase of technological development
a. Phases: pre-development, development, take-off,
acceleration, stabilization phases (S-curve).
3. Functional analysis follow the system over-time.
4. System failure where are the bottlenecks?
5. Policy instruments
There are several actors like firms, governments, knowledge
institutions, demand side and intermediaries. Firms are startups, multinationals etc, governments can
be national, European, regional etc, knowledge institutes can be universities, applied universities,
research institutes etc, demand side is consumers, patients, citizens, users but also firms,
intermediaries are consultants, network organizations and interest groups etc.
Networks are there where there is knowledge and money. They might be formal or informal, digital, or
face-to-face. It is important to look at the nature of a network.
For institutions the same applies but there are more formal rules such as laws or regulations.
Moreover, there also might be informal institutions like norms, values, and habits. Infrastructure can
be physical; it can be knowledge, or it can be financial. With the help of this, you can do the structural
analysis where you form the structure of the innovation system.
In the functional analysis (step 3) you are going to look at several system functions. These system
functions are:
1. Entrepreneurial experimentation
a. Here you look at ne number of clinical trials, new entrants or new biologicals. You for
example look at the increase in entrepreneurial activities over time for a specific
antimalarial drug or at the increase of product diversification.
2. Knowledge development
a. Here you look at scientific publications, patents, citations etc. You for example look at
the knowledge production focusing on the underlying mechanism of a disease.
3. Knowledge exchange
a. Here you look at workshops, conferences, meetings and networks that are being
organized around specific types of diseases.
4. Guidance of the search
a. Here you look at regulations, standards, rules, collaborative governance and
expectations. You could look at the role of the EMA (European Medicines Agency) as
market introduction of a particular drug can lead to establishment of specific EMA
Working Parties.
5. Formation of markets
a. Here you look at market approvals and medical guidelines development.
6. Mobilization of resources
a. Here you look at financial investments, funding programs, Public-private partnership
initiatives and at financial, human and knowledge resources.
, 7. Counteracting resistance to change/legitimacy creation
a. Here you look at lobby activities of patient
organizations and media coverage.
For each phase of development, there are several functional patterns in
which specific functions are relevant to investigate. For pre-
development, these functions are F2, F3, F4 and F6. For the
development phase this is all phases. For the take-off phase these are
F1, F4, F5, F6, and F7. For the acceleration phase these are F1, F4, F5
and F6.
There can be functional barriers for the system functions which you are going to look at in step 4. Here
you determine which system functions are forming a barrier and you determine which structural
component forms the barrier; actors, networks, institutions, technology or external factors. Here, you
also describe the relation between the cause and the barriers.
In step 5, policy instruments are discussed. Innovation policies support companies to perform better
and it contributes to wider social objectives such as growth, jobs and sustainability. There are several
policy tools:
1. Establishing supportive framework conditions
2. Facilitating access to finance
3. Policy benchmarking
4. Enabling collaboration
5. Stimulating demand
The choice on which policy tool is used depends on the structural cause for the functional barriers in
the innovation system, the policy goal and the geographical/technological scope of the TIS.
The Global Innovation system perspective is a
framework for analyzing innovation processes
in a transnational context by focusing on a
generation of resources in multi-scalar
subsystems and the formation of couplings
between geographically-dispersed subsystems.
It integrates the key system functions of the
TIS. It also conceptualizes the functions of the
TIS as system resources and it particularly
focuses on knowledge creation (F2), market
formation (F5), resource mobilization (F6) and
legitimacy creation (F7). It adds a geographical
dimension as systems can now be organized on
multiple geographical locations. All multi-
located systems are made effective through
structural couplings. These are actors,
networks or institutions spanning across of
overlapping between various innovation systems. Examples of structural couplings are:
1. Transnationally-operating institutions
2. International associations
3. NGOs
Article Hekkert 2011: Technological Innovation System Analysis
The most important insight that has dominated the field of innovation studies in recent decades is the
fact that innovation is a collective activity. It takes place within the context of a wider system. This
wider system is coined ‘the innovation system’ or ‘the innovation ecosystem’. The success of
Lecture 1: Introduction Sustainability, Health & Innovation – Ellen Moors
There are millennial development goals which are very limited, and which focus more on public
sectors, poverty, and public health. Sustainable development goals focus more on private sectors and
the goals are more comprehensive. There are 17 SDG’s. here, each goal is important which is the
focus of the course, but they keep being connected. We focus mainly on SDG-3, SDG-10, and SDG-
13. The focus is on life sciences, health and ageing, medical devices, healthy foods, and healthy urban
living.
Innovation in life sciences and health is science-driven with a high attrition-rate. The development
times are normally extensive for products, normally because for the vaccinations this was not the case.
There is a dominance of patents, which high R&D costs. It is very regulated which is different from
other industries such as that you need approvals, reimbursement by health authorities all additional
steps to get new products on the market. Moreover, there is not much choice for patients there are 3
vaccines. The patient is not in a powerful position which is different from other industries.
The pharmaceutical industry is in a crisis where there is a focus on orphan drugs, more drugs lead to
unknown diseased with insufficient data. It is also interesting to focus on cancer as they are expensive.
The number of drugs without efficacy is increasing and the number of pharmaceutical and
biotechnology companies are decreasing. The cause of the crisis is because of all drug regulations,
they are more and more dependent on research institutes and the role of academia is changing. Barriers
in innovation systems is that new products are expensive, less effective which leads to inequalities
locally, nationally, and world-wide regarding availability, affordability, access, and the safety/quality
of essential medicines. The current drug innovation system is not sustainable anymore, the question is
how to make it more sustainable by understanding the 5 qualities of drug development:
1. Available
2. Affordable
3. Accessible
4. Acceptable
5. Safe
Price controls, reference pricing, pharmaco-economic evaluation, negotiated prices and central
purchase are terms that can be used for a transition to sustainable drug development. You can also
think about reimbursement cap, pay-for-cure, or other distributed drug innovation models. All these
aspects are a way to deal with prices in the drug development. There are some possible strategies like:
- Through the legal system
o Via patent legislation
o Via abolishment data protection by regulatory authorities
o Via Eu legislation against cartels
o Via Human Right Legislation
- Following a non-profit approach by using alternative drug development models. It is to gain a
better image. Magistral production is a new way to develop drugs which is used more in the
Netherlands.
New models of sustainable drug development focus on the four A’s and the S.
Drug development model
There is a model for drug development where there are 5 main stages. They are central and then there
are several steps where there could be bottlenecks. In the clinical phase there are 3 stages, the fourth
stage is the post marketing surveillance stage. Drug discovery is about a disease to be treated or
prevented where you need a target which is expected to do something. Drugs need to be syntheses in a
chemical or biological way, the last one is more difficult. It is important to look for that molecule with
the best properties. First, you characterize the molecule (in vitro phase). Then we go to testing phase to
,test how toxic and effective it is for animals (in vivo phase). Many of the biological medicines tested
on mouses are not representative for humans because they are very complex. Chemical compounds are
more generally applicable. Clinical phase 1 is already in the human, often with volunteers to
experiment. They test the kinetics, does it work? And the dynamics, where does it work? If that works,
we have the proof of concept where you find out whether the medicine is working like expected. For
covid, we stopped between phase 1 and phase 2. For phase 3 we need placebo and time to test the
medicine on a lot of people. Then you go to the EMA to get the drug approved which is after about 12-
15 years. You end up with one approved drug. The failure of the medicine depends on the type of
disease. The overall success rate is around 11%.
After approval you need to show the safety over time in reports, then you can work on label extensions
(later vaccinate 18- instead of only 18+), then we have the reimbursement and the discussion of the
pricing. Reimbursement is very important as it must be affordable to be effective for people.
Different actors have different wishes such as the industry, patient groups, payers, and the
media/scientific community. Some groups are working to a shorter timeline while others want more
studies/patients.
Article Atun: Health systems, system thinking and innovation
Lessons emerging from instances of low innovation adoption suggest that when addressing health
problems, reductionist and linear approaches that provide technical solutions alone are not adequate to
mount effective responses, as the adoption and diffusion of innovations which underpin responses to
health problems are influenced by complex health systems, the
socio-political context within which the health systems are embedded and the innovation adoption
system.
Multiple interacting factors influence adoption of innovations, ranging from new technologies, to
novel service delivery models and to health policies. Therefore, a broader and more sophisticated
analysis of the context, health system elements, institutions, adoption systems, problem perception and
the innovation characteristics within these will enable better understanding of the short- and long-term
effects of an innovation when introduced into health systems. A simplistic situational analysis may
result in barriers and enablers to innovation adoption being overlooked, and risk unforeseen
consequences and policy resistance. One way to reduce this policy resistance is to adopt systems
thinking to look at all interacting elements within the complex adaptive health systems in a holistic
manner to devise effective responses.
Combining technological innovations with other innovations in health systems (such as innovative
approaches to governance, financing, service delivery, awareness creation and demand mobilization)
enables effective adoption of innovations in health systems.
Systems thinking can help understanding of the dynamic complexity that characterizes complex
adaptive systems. The dynamic complexity which emerges from bidirectional inter- action among
innovations, entities adopting innovations, institutions, health systems, and the context in which health
systems are embedded will need to be understood to help devise policies and tactics to enable effective
adoption and diffusion of innovations in health. While health systems as adaptive systems are
complex, their understanding informed by systems thinking need not be complicated.
,Lecture 2: Innovation systems – Ellen Moors
The 4 As are affordability, availability, acceptability, and accessibility. They can help to show
challenges within scopes. A problem can occur because of policy problems, management issues or
research puzzles. With the help of research and theory, you can operationalize the problem. Health-
related innovation needs to be part of the paper, therapy, diagnostic device or medical technology or
prevention procedure. The 5 steps for analyzing a technological
innovation system are:
1. Structural analysis
a. Components: Actors, institutions, networks,
infrastructure & technological factors
2. Phase of technological development
a. Phases: pre-development, development, take-off,
acceleration, stabilization phases (S-curve).
3. Functional analysis follow the system over-time.
4. System failure where are the bottlenecks?
5. Policy instruments
There are several actors like firms, governments, knowledge
institutions, demand side and intermediaries. Firms are startups, multinationals etc, governments can
be national, European, regional etc, knowledge institutes can be universities, applied universities,
research institutes etc, demand side is consumers, patients, citizens, users but also firms,
intermediaries are consultants, network organizations and interest groups etc.
Networks are there where there is knowledge and money. They might be formal or informal, digital, or
face-to-face. It is important to look at the nature of a network.
For institutions the same applies but there are more formal rules such as laws or regulations.
Moreover, there also might be informal institutions like norms, values, and habits. Infrastructure can
be physical; it can be knowledge, or it can be financial. With the help of this, you can do the structural
analysis where you form the structure of the innovation system.
In the functional analysis (step 3) you are going to look at several system functions. These system
functions are:
1. Entrepreneurial experimentation
a. Here you look at ne number of clinical trials, new entrants or new biologicals. You for
example look at the increase in entrepreneurial activities over time for a specific
antimalarial drug or at the increase of product diversification.
2. Knowledge development
a. Here you look at scientific publications, patents, citations etc. You for example look at
the knowledge production focusing on the underlying mechanism of a disease.
3. Knowledge exchange
a. Here you look at workshops, conferences, meetings and networks that are being
organized around specific types of diseases.
4. Guidance of the search
a. Here you look at regulations, standards, rules, collaborative governance and
expectations. You could look at the role of the EMA (European Medicines Agency) as
market introduction of a particular drug can lead to establishment of specific EMA
Working Parties.
5. Formation of markets
a. Here you look at market approvals and medical guidelines development.
6. Mobilization of resources
a. Here you look at financial investments, funding programs, Public-private partnership
initiatives and at financial, human and knowledge resources.
, 7. Counteracting resistance to change/legitimacy creation
a. Here you look at lobby activities of patient
organizations and media coverage.
For each phase of development, there are several functional patterns in
which specific functions are relevant to investigate. For pre-
development, these functions are F2, F3, F4 and F6. For the
development phase this is all phases. For the take-off phase these are
F1, F4, F5, F6, and F7. For the acceleration phase these are F1, F4, F5
and F6.
There can be functional barriers for the system functions which you are going to look at in step 4. Here
you determine which system functions are forming a barrier and you determine which structural
component forms the barrier; actors, networks, institutions, technology or external factors. Here, you
also describe the relation between the cause and the barriers.
In step 5, policy instruments are discussed. Innovation policies support companies to perform better
and it contributes to wider social objectives such as growth, jobs and sustainability. There are several
policy tools:
1. Establishing supportive framework conditions
2. Facilitating access to finance
3. Policy benchmarking
4. Enabling collaboration
5. Stimulating demand
The choice on which policy tool is used depends on the structural cause for the functional barriers in
the innovation system, the policy goal and the geographical/technological scope of the TIS.
The Global Innovation system perspective is a
framework for analyzing innovation processes
in a transnational context by focusing on a
generation of resources in multi-scalar
subsystems and the formation of couplings
between geographically-dispersed subsystems.
It integrates the key system functions of the
TIS. It also conceptualizes the functions of the
TIS as system resources and it particularly
focuses on knowledge creation (F2), market
formation (F5), resource mobilization (F6) and
legitimacy creation (F7). It adds a geographical
dimension as systems can now be organized on
multiple geographical locations. All multi-
located systems are made effective through
structural couplings. These are actors,
networks or institutions spanning across of
overlapping between various innovation systems. Examples of structural couplings are:
1. Transnationally-operating institutions
2. International associations
3. NGOs
Article Hekkert 2011: Technological Innovation System Analysis
The most important insight that has dominated the field of innovation studies in recent decades is the
fact that innovation is a collective activity. It takes place within the context of a wider system. This
wider system is coined ‘the innovation system’ or ‘the innovation ecosystem’. The success of
