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Current Insight
Using Blockchain in
the Pharmaceutical
ColdChain
FACT SHEET
User Management Data Acquisition Data Acquisition User Management
User Interface &
Reporting
Data Processing Data Processing User Interface &
Reporting
UsingBlockchaininthePharmaceuticalColdChain
Inthepastfewyears,theuseofblockchainforthepharmasupplychainhasbeenwidelydiscussed.
Afewcompanies have already tried to find use-casesin theindustry but so far withlimited success.
Tounderstand the reasonforthis, we needtofirstlookat the difference between aclassical database
and ablockchain.
Elements of a supply chain solution
A supply chain data management solution is more than just
a place to store and secure data. Today with auto-
mationtechnologies,sophisticatedsoftwareandAI–supply
chain data solutions are expected to seamlessly process
highvolumesofdatain seconds,provide locktight security
and compute unlimited parallel algorithms. Let’s compare a
supply chain solution using a database as well as a solu-
tion usingblockchain.
The main difference lies in the level of centralization of
thedata storageand security measures. Whilein asolution
working with a simple database, all records are secured in
one central location, each participant on a blockchain has
a secured copy of all records and all changes.
Supplychainsolutionwithsimpledatabase Supply chain solution using blockchain
Blockchain
Copy
Copy
Copy
Central Database
Back-up
Database (for
Blockchain Administrator)
Howisblockchaindifferentthan
your standard database?
In a database, the owner of the database is responsible
for the safety of the data (protection from loss or mani-
pulation). Inablockchain,each usercan verify wherethe
data comes from and who has added changes to the data.
Blockchainhasanadditionalsecuritylayermakingsurethat
after data collection and archiving, nobody can manipulate
the data.
Blockchain takes enormous calculation capacity with
constant encryption, distribution of the data (blocks) to
countless participants, and continuous comparison of
data. Thus adding a blockchain, means adding significant
computingcapabilities.InChina, wheremostofthe Bitcoin
mining takes place because of low energy cost, they build
entire power plants feeding the Bitcoin mills.
Database Blockchain
What is it? A database is a structure where
data is collected in a structured
way.
Blockchain is a growing list of records (blocks),
thatarelinkedusingcryptography.Eachblock
contains a reference to the previous block (so called
“cryptographic hash”) a timestamp, and transaction
data.
Where is the data? Central Decentralized
Redundancy One copy (no redundancy) Exact copies of the same data in many places
Protection from loss Back-up and recovery Secured by the system
Protection from wrong
data entries
Firewalls, encryption, user
management, authentication
Firewalls, encryption, user management, authentication
Protection from
manipulation
No-delete functionality,
audit trails
After the data is in the blockchain, there is no
manipulation possible (since the data is replicated
to many users keeping a copy).
Trust in data collection Database owner must make
sure that data entered into the
database has the right quality.
Softwareprovider(usingblockchain)mustmakesure
that data entered into the blockchain has the right
quality
Trust in data storage and
long-term archiving
Database owner warrants
for the trust
Secured by the nature of the blockchain
Cost for data protection
(protection from loss and
manipulation) Thesamedatamustbeprocessed,authenticated
and stored in manyplaces.
What are the overall benefits of blockchain?
Blockchainisarevolutionarytechnology sinceitoffersnew
ways of collaboration and information exchange of many
partners in a supply chain. It has various benefits:
> Immutability:Dataoncestoredcannot bemanipulated
or modified
> Transparency:Offerstransparencysothatbusiness
can track every systemdetail
> SubstituteforTrust:Partiesthat don’t knowortrust
each other cancollaborate
> Traceability:Offersall-timetraceabilitythat
prevents fraudulentactivities
> Security:Utilizeshigh-levelcryptography algorithms
and methods
Blockchain can solve problems traditional databases have
never solved before.Oneofthebest-known examplesisin
the diamond business where there is a lack of transparen-
cy and trust in the entire industry. Diamond miners don’t
trusttheprocessors, theprocessorsdon’t trustthedealers
and how should the end-customer trust the claimed origin
of a diamond he is purchasing in a jewelry? A blockchain
solution where each diamond is registered centrally and all
involved parties can exchange information on one single
items along the supply chain is truly solving a problem to
many involved parties.
Isblockchainsolvingthepharma
supplychainchallenges?
Would a blockchain also solve the problems of the pharma
supply chain? Many participants are along the supply chain
dealing all with the same product but today they are hardly
exchanging information. Wouldn’t it be great, if we had a
system where all the information on the drug product is
shared across the supplychain?
> Patients would be sure about the quality of drugs. The
data in the blockchain would tell them that the drug is an
original and OK to use, not expired and total time out of
refrigeration(TOR)hasnotexceededthestabilitybudget.
> Market Authorization Holders (MAH)couldgain valuable
information on the supply chain efficiency as well as on
the patients (where and when is my product used?).
Blockchain could solve many of the problems of the pharma
supply chain. It could even be a substitute for trust and it
could offer all-time traceability. The problem is:
1. That lack of trust between the supply chain partners is
not the main concern in the pharmaceutical industry.
Serialization has pretty much solved the problem of
counterfeit.
2. Traceabilityisnecessaryforpharmaceuticals–butthe
argumentthatblockchainoffers“all­timetraceability”
is stronger for diamonds lasting generations than for
pharmaceuticals having an expiry date of average
18 months.
3. Without true innovation, blockchain is just adding
extrasecuritylayers(whicharenoturgentlyneeded)
and this is adding extra cost without increasing
efficiency or making other steps redundant.
Immutability
Data once stored
can not be manipulated
or modified.
Transparency
Offers transparency
so that business can track
every system detail.
Substitute for Trust
Parties that don’t know or
trust each other
can collaborate.
Traceability
Offers all-time traceability that
prevents fraudulent activities.
Security
Utilizes high-level
cryptography algorithms and
methods.
Benefits of Blockchain for Pharma Supply Chain
Benefits of a Database for Pharma Supply Chain
Summary
It is clear there are benefits using blockchain for many
applications, especially those that require a high level of
security and need to solve trust issues between trading
partners. Currently, it seems the concept and application for
using blockchain in the pharma supply chain is notfully
formulated and benefits would not be quickly realized.
This new technology will be successful in other industries
first before it finds its way into the pharma supply chain.
Therefore,aclassicaldatabaseisprobablythebetterchoice
to solve the end-to-end monitoring challenge.
Security
Can also use high-level
cryptography algorithms and
methods.
Audit-Trail
Offers traceability that prevents
fraudulent activities.
Efficiency
Database is an efficient
way to keeping and
exchanging data.
Transparency
Offers transparency
so that business can track
every system detail.
Add-only
Don’t allow changes
to raw-data,
each change is kept
in an audit trail.
ThisFactSheetispartoftheColdChainMonitoring&Logistics
website content for supply chain and QA practitioners.
Topics include elements of a supply chain solution; how a blockchain is different
than your standard database; the overall benefits of a blockchain; and if a block-
chain is solving the pharma supply chain challenges.

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current insight using blockchain in the pharmaceutial cold chain

  • 1. Current Insight Using Blockchain in the Pharmaceutical ColdChain FACT SHEET
  • 2. User Management Data Acquisition Data Acquisition User Management User Interface & Reporting Data Processing Data Processing User Interface & Reporting UsingBlockchaininthePharmaceuticalColdChain Inthepastfewyears,theuseofblockchainforthepharmasupplychainhasbeenwidelydiscussed. Afewcompanies have already tried to find use-casesin theindustry but so far withlimited success. Tounderstand the reasonforthis, we needtofirstlookat the difference between aclassical database and ablockchain. Elements of a supply chain solution A supply chain data management solution is more than just a place to store and secure data. Today with auto- mationtechnologies,sophisticatedsoftwareandAI–supply chain data solutions are expected to seamlessly process highvolumesofdatain seconds,provide locktight security and compute unlimited parallel algorithms. Let’s compare a supply chain solution using a database as well as a solu- tion usingblockchain. The main difference lies in the level of centralization of thedata storageand security measures. Whilein asolution working with a simple database, all records are secured in one central location, each participant on a blockchain has a secured copy of all records and all changes. Supplychainsolutionwithsimpledatabase Supply chain solution using blockchain Blockchain Copy Copy Copy Central Database Back-up Database (for Blockchain Administrator)
  • 3. Howisblockchaindifferentthan your standard database? In a database, the owner of the database is responsible for the safety of the data (protection from loss or mani- pulation). Inablockchain,each usercan verify wherethe data comes from and who has added changes to the data. Blockchainhasanadditionalsecuritylayermakingsurethat after data collection and archiving, nobody can manipulate the data. Blockchain takes enormous calculation capacity with constant encryption, distribution of the data (blocks) to countless participants, and continuous comparison of data. Thus adding a blockchain, means adding significant computingcapabilities.InChina, wheremostofthe Bitcoin mining takes place because of low energy cost, they build entire power plants feeding the Bitcoin mills. Database Blockchain What is it? A database is a structure where data is collected in a structured way. Blockchain is a growing list of records (blocks), thatarelinkedusingcryptography.Eachblock contains a reference to the previous block (so called “cryptographic hash”) a timestamp, and transaction data. Where is the data? Central Decentralized Redundancy One copy (no redundancy) Exact copies of the same data in many places Protection from loss Back-up and recovery Secured by the system Protection from wrong data entries Firewalls, encryption, user management, authentication Firewalls, encryption, user management, authentication Protection from manipulation No-delete functionality, audit trails After the data is in the blockchain, there is no manipulation possible (since the data is replicated to many users keeping a copy). Trust in data collection Database owner must make sure that data entered into the database has the right quality. Softwareprovider(usingblockchain)mustmakesure that data entered into the blockchain has the right quality Trust in data storage and long-term archiving Database owner warrants for the trust Secured by the nature of the blockchain Cost for data protection (protection from loss and manipulation) Thesamedatamustbeprocessed,authenticated and stored in manyplaces.
  • 4. What are the overall benefits of blockchain? Blockchainisarevolutionarytechnology sinceitoffersnew ways of collaboration and information exchange of many partners in a supply chain. It has various benefits: > Immutability:Dataoncestoredcannot bemanipulated or modified > Transparency:Offerstransparencysothatbusiness can track every systemdetail > SubstituteforTrust:Partiesthat don’t knowortrust each other cancollaborate > Traceability:Offersall-timetraceabilitythat prevents fraudulentactivities > Security:Utilizeshigh-levelcryptography algorithms and methods Blockchain can solve problems traditional databases have never solved before.Oneofthebest-known examplesisin the diamond business where there is a lack of transparen- cy and trust in the entire industry. Diamond miners don’t trusttheprocessors, theprocessorsdon’t trustthedealers and how should the end-customer trust the claimed origin of a diamond he is purchasing in a jewelry? A blockchain solution where each diamond is registered centrally and all involved parties can exchange information on one single items along the supply chain is truly solving a problem to many involved parties. Isblockchainsolvingthepharma supplychainchallenges? Would a blockchain also solve the problems of the pharma supply chain? Many participants are along the supply chain dealing all with the same product but today they are hardly exchanging information. Wouldn’t it be great, if we had a system where all the information on the drug product is shared across the supplychain? > Patients would be sure about the quality of drugs. The data in the blockchain would tell them that the drug is an original and OK to use, not expired and total time out of refrigeration(TOR)hasnotexceededthestabilitybudget. > Market Authorization Holders (MAH)couldgain valuable information on the supply chain efficiency as well as on the patients (where and when is my product used?). Blockchain could solve many of the problems of the pharma supply chain. It could even be a substitute for trust and it could offer all-time traceability. The problem is: 1. That lack of trust between the supply chain partners is not the main concern in the pharmaceutical industry. Serialization has pretty much solved the problem of counterfeit. 2. Traceabilityisnecessaryforpharmaceuticals–butthe argumentthatblockchainoffers“all­timetraceability” is stronger for diamonds lasting generations than for pharmaceuticals having an expiry date of average 18 months. 3. Without true innovation, blockchain is just adding extrasecuritylayers(whicharenoturgentlyneeded) and this is adding extra cost without increasing efficiency or making other steps redundant.
  • 5. Immutability Data once stored can not be manipulated or modified. Transparency Offers transparency so that business can track every system detail. Substitute for Trust Parties that don’t know or trust each other can collaborate. Traceability Offers all-time traceability that prevents fraudulent activities. Security Utilizes high-level cryptography algorithms and methods. Benefits of Blockchain for Pharma Supply Chain Benefits of a Database for Pharma Supply Chain Summary It is clear there are benefits using blockchain for many applications, especially those that require a high level of security and need to solve trust issues between trading partners. Currently, it seems the concept and application for using blockchain in the pharma supply chain is notfully formulated and benefits would not be quickly realized. This new technology will be successful in other industries first before it finds its way into the pharma supply chain. Therefore,aclassicaldatabaseisprobablythebetterchoice to solve the end-to-end monitoring challenge. Security Can also use high-level cryptography algorithms and methods. Audit-Trail Offers traceability that prevents fraudulent activities. Efficiency Database is an efficient way to keeping and exchanging data. Transparency Offers transparency so that business can track every system detail. Add-only Don’t allow changes to raw-data, each change is kept in an audit trail.
  • 6. ThisFactSheetispartoftheColdChainMonitoring&Logistics website content for supply chain and QA practitioners. Topics include elements of a supply chain solution; how a blockchain is different than your standard database; the overall benefits of a blockchain; and if a block- chain is solving the pharma supply chain challenges.