Quick market entry (medical)

Jan Softa at Somerco Date: 2013-03-31
Somerco, Suite 177, 372 Old street, EC1V 9LT London, UK. info@somerco.com
Enhance the competitiveness of the EC member states
Part 22 – Quick market entry (Medical)
Abstract
To have a plan for quick market entry for the products from the pharmacy industries in combination with the
treatment provided by the health sector will have large societal effects. The areas to focus on is the research and
development phase of medicine, concerns around patents and open source alternatives, approval of medicine, the
production phase of medicines, its sale channels and the feedback the evaluation of treatment has for quicker
medicine development. Therefore, EU should create collaboration among pharmacy companies, the health sector,
producers of lab equipment and production machines, IP lawyers and advocates for open source.
Background
Helping geniuses! Our slogan sums up whom Somerco aims to help. Somerco are a company
that target to help researchers and innovators so that these geniuses can create prosperity and
jobs in society. The ITRE committee has held discussions about it are necessary to improve the
competitiveness of European SMEs and large companies in pharmacy. The reason was to figure
out if it is possible for these companies to get a quick market entry of its products and services. I
would also lift forward the health sector as an important part of medical treatment. In this paper,
I have created a model that can enable a quick market entry.1
Introduction
A plan for quick market entry for the pharmacy industries products in combination with the
treatment provided by the health sector will have large societal effects. For SMEs and large
companies a quick market entry for their products and services will enhance their
competitiveness against competitors outside EU. For you and me it will mean possibilities to
improved health faster since these products and treatments will be available sooner. For
government it should mean an improved service to its inhabitants and a more efficient use of
money spent. The same should apply for those countries that rely more on the private sector to
provide the same service to the inhabitants.
EU – contribution
In particular, EU can contribute in legislation and funding to achieve a quick market entry for
medicine. The areas to focus on is the research and development phase of medicine, concerns
around patents and open source alternatives, approval of medicine, the production phase of
medicines, its sale channels and the feedback the evaluation of treatment has for quicker
medicine development.
Schema: Process for quick market entry
1
Other issues relevant for how you can gain a quick market entry for innovations in the medical sector concern how
EU can help companies by providing financial means to these in buy-outs and mergers. It concern start-ups, SMEs
and large companies. However, it is not the focus in this paper.
EU-contribution
Legislation, funding and (networking)
R & D Patent/
Open
source
Approval Production Treatment/
Evaluation
Sales

R&D
EU has a strong record when it concern funding of R & D of medicines with its different
framework programs that has been run. In its latest Horizon 2020, the largest funding program of
the planet, EU has made a huge effort to help companies become more competitive by giving
advice, funding and business contacts that could provide equity. No matter the prior frameworks
success there is room for improvement. This can be achieved by continuing to develop the
framework programs during their running and in the evaluation before next start of a new
framework program that would start 2021.
Also legislation that enables R & D projects to be conducted cross-borders without hindrance has
been adopted. It is established in the Single European Act that enables free movement of
workers, product and services. While the discussion of particular efforts in the realms of R & D
for a quick market entry for medicines can be worked out in the different units of the
Commission and at the committees of the Parliament its adaptation would be a part of the single
EU market. It has a large foundation for legislative changes that enables a quick market entry of
medicines.
Lab equipment and science software is a vital part of R & D in medicine development. Most
universities and companies would like to have all types of high quality lab equipment. However,
it is not possible. Older lab equipment is slowing down the process of medicine development.
Therefore, it is beneficial to develop a program for those conducting R & D in medicine
development that enables access to high class lab equipment cross-borders. Besides the quality
these can provide, issues that should be considered is price to use these, an effective logistic of R
& D projects that enables many access to these facilities. EU should discuss with companies and
universities that have and want to offer lab equipment to many other about how it would be
possible to create a European network easy to get access too.
Patent
Traditionally, pharmacy companies have opted to patent their medicines before releasing them
on the market. A huge improvement could be made in the patent phase by decreasing the time to
get a patent to 1/3. It will be achieved by implementing a designated tax to science in European
countries. Large companies who conduct R & D pay once a year a tax of 1-2% on their turnover
for a particular month. These tax money has to be designated for speeding up the time to process
IP applications by hiring more staff in both the member states Patent Offices and at the European
Patent Office, other funds goes to educate and hire more staff in courts in order to resolve IP
disputes and another part of these tax money should be available for SMEs to apply for in order
to use when they need to hire IP lawyers and their investigators in IP disputes.2
There is a need for EU to advice on how EUs patent approval process functions to other
countries. It could also be beneficial to give an initial funding to nations with less financial
resources in order for these to have an effective approval process for patents. For instance, it
would be possible for them to use the same software systems used by EPO for their national or
regional application process. Another alternative is to fund their governmental officials to study
EUs patent process and visit EPO, the Commission and the Parliament. It is also possible for EU
to advise those countries who want to adopt a similar system as us. Then EPO could put together
and offer an educational package about EUs patent system that would be adopted into the
education curricula of these countries IP professionals.
Open source
Open source development of medicines could be more rapid due to unrestricted input from
research from all over the globe. To open source medical discoveries has become increasingly
2
I have a more in-depth discussion about this tax in the paper: Enhance the EC member states competitiveness. Part
1. - Designated tax to science. http://tinyurl.com/n5qrhdl

accepted by professionals in medicine. For large pharmaceuticals, it has been done when it is
difficult to make great profit on medicines to cure diseases where there is a great need. For
malaria, it is because those vulnerable to malaria are in parts of the world with populations that
would not be able to afford patented solution for medicines. There also those scientist with a
focus on the social impact of society rather than focus on achieving a huge profit. This is more
valid for scientist at research institutes.
EU could work with the open source development in different ways. EU could require that so
called research leftovers from projects funded by them are open sourced for others to do research
on 24 months after the end of a project has passed. It means, if not any project participants has
patented or continued to conduct research on some of the parts, the research findings are open for
other researchers to use. It will enable a more rapid development of medicines since pharmacy
companies of all sizes get access to prior but current quality research for free that they can
continue to do research on in their chosen direction. I also believe it would be possible to give
funding to projects that are open sourced from the start. It enables a mass to contribute and not
just a few.3
If humanitarian aspects were to be considered, EU could help medicines with open source
solutions and its developers by finding private or institutional distributors the right channels to
international organizations as UN, Red Cross etc so its users will receive the medicines more
quickly.
To conclude, it would be beneficial if there was a discussion about how EU can run open source
projects for development of medicine.
Approval
Quality in the approval of medicine is vital. It is also not uncommon that this phase is a lengthy
process that sometimes has taken years. Europe's medicines regulator is discussing measures in
this area that would speed up the approval of medicine and enable a quicker market entry for
medicines. The decision to pilot so-called adaptive licensing reflects urgency among health
authorities to find ways of making promising medicines available earlier, instead of waiting
years for them to work their way through the traditional approval process.4
Under adaptive licensing, a medicine would get early authorisation for use in a restricted patient
population, followed by further evidence gathering and adaptations of approval to expand access
to broader patient groups. Hans-Georg Eichler, senior medical officer, from the European
Medicines Agency said the programme would target medicines that addressed serious conditions
with unmet medical needs.
"The approach seeks to maximize the positive impact of new medicines on public health by balancing timely access
for patients with the need to provide adequate evolving information on their benefits and risks," he said in a
statement.
The approval of medicines is a focus area for EU in order to get a quicker market entry for
medicine in Europe. Also US have a similar program on its way.
Production
It is important to have flexibility in production capacity so it is easy to scale up the volume of
produced medicines in order to be a successful pharmacy company. To focus on helping the
machine producers that construct them should be a corner stone in an EU strategy if they want to
have a quick market entry of medicine. For smaller pharmacy developers production capacity
3
A more in-depth knowledge can be found in Enhance the EC member states competitiveness. Part12 - Research
leftovers. http://www.slideshare.net/SomercoResearch/research-leftovers
4
EU looks to speed drug access with staggered approval process.
http://www.reuters.com/article/2014/03/19/pharmaceuticals-europe-idUSL6N0MG51A20140319

can be a hindrance due to not having enough capacity in their machine park. An option is then to
licence production to others. And often subcontracting to others is considered a cheaper
alternative than to buy new production machines, but it is not necessary the case for smaller
pharmacy companies. If you account it still takes extra time and it is not sure this pharmacy
company will be first in line. This loss of time leads to less income and it is a cost these
pharmacy companies have to put on the medicines that they sell to its customers.
An option is to let pharmacy companies get favourable loans in order to have flexible production
facilities and a competitive machine park. It would be possible to work out a requirement list for
high-class machinery. It may be procurement of new machinery or what updates that is required
of their current machinery. EU could take a lead and discuss with the machine producers and
pharmacy companies these requirements that could be part of the evaluation process the banks
and financial institutions use to determine who gets to lend money that has been provided by
EIB.
Sales
No matter how good your medicine might be - sale matters. It is a key part of achieving a quick
market entry that has effect. It can be done by traditional sales between salesman to customer as
doctors and online.
When it concern sale of different medicines the determinate is what access end customers has to
these. Medicines as for a sore throat and headache can be purchased in stores and online.
Prescript medicine can be bought at the pharmacy. Besides buying over the counter, you can also
find solutions were you order your medicines on controlled online software solutions that enable
home delivery or a pick up these at a store nearby.
To build up your own sales-channels for salesman-to-doctor is a cost that can slow medicines to
reach the market quick. It is more valid for newer pharmaceuticals than established. New
medicines from smaller pharmaceuticals need effective sales channels in the phase from
salesman to doctors. Often it has meant that agent companies as Johnson and Johnson take up
their products in their product portfolio. For small pharmaceuticals to use sales agents is
effective in the sense that they can reach a global market. These agent companies share of the
profit means lower profit if counted per product. However, a high increase of sales volume can
more than make up for this loss. From a competitive perspective it is the only way for small
pharma companies that want to use pharma reps in order to compete with global pharmaceuticals
products. Global pharmaceuticals have the advantage to have their own pharma reps and thereby
have it easier to educate their staff and get newer medicines to the market quicker. It often means
a reduction in time before they get profit for their medicines per sale unit.
EU should discuss how smaller pharmaceuticals can narrow the gap in time and have a quicker
market entry so they achieve profit sooner. Maybe there is a need for a European pharma sales
agent to grow large in Europe and then global with a business and logistic strategy that enables a
quick market entry for medicine from pharmacy companies of all sizes.
Treatment/evaluation
Besides approval of medicines, an important part of evaluation of medicines is during treatment
of patients. The feedback helps to improve current and future medicine development. With clear
knowledge of how to use the medicines and most important evaluate its effectiveness and side-
effects it is the health sector that could be a vital part in the next phases of development of these
medicines. In particular, countries equivalent to UKs National Institute for Health and Clinical
Excellence (NHS) is in centre in the feedback that should be provided back to the
pharmaceuticals.
When EU fund R & D of medicines focus is on discovering new drugs that are innovative and
safe. These projects are then conducted by pharmacy companies with high ambitious. It is

important for EU to continue to fund these projects because it is costly to develop medicine and
often these medicines might not be able to commercialize in the near future. It is a delay in profit
many pharmacy companies is not prepared to take unless there is financial aid in the initial parts
of the drug development.
However, it would also be possible for EU to in a call have a focus on how feedback from the
health sector can enable quicker improvements and developments of medicine. Here, it is the
feedback from the health sector that is in centre for how pharmacy companies develop its drugs.
The evaluation of medicines from the health sector has the potential to compare different brands
currently on the market that aim to cure the same. Thereby, it is not a potential promising
research discovery that gets funding, but rather the feedback the health sector can provide that
get funding and enable Pharmacy Company’s research and develop new medicine. It means in
this call the health sector will be in the driving seat of medicine development.
Conclusion
It would be beneficial for EU, pharmacy companies and the health sector to discuss future roads
to a quicker market entry for medicine. Sometimes funding needs to be allocated to speed up the
processes for a quicker market entry, other times improved legislation, other times knowledge
needs to be shared among those involved in drug development and there may be need for
developing a strong cross – border network among European companies. And a stronger network
that includes pharmacy companies, the machine manufacturers, the health sector, sales agents, IP
lawyers, advocates of open source and governmental agencies. With an overview of these phases
it is easier to first discuss and then decide where the focus should be.

Draft proposals
Enhance the competitiveness of EC member states Part 1 - Designated tax to science
Enhance the competitiveness of EC member states Part 2 – Strategy to support the software industry
Enhance the competitiveness of EC member states Part 3 – Actions to support women in ICT
Enhance the competitiveness of EC member states Part 4 – Going abroad–Competitive assets
Enhance the competitiveness of EC member states Part 5 – Business incubators, financial recycling and incentives
into reward
Enhance the competitiveness of EC member states Part 6 – Standardization as a tool to increase competitiveness
Enhance the competitiveness of EC member states Part 7 – Different types of innovations
Enhance the competitiveness of EC member states Part 8 – Open source from science to society
Enhance the competitiveness of EC member states Part 9 – Crowd sourcing and crowd funding
Enhance the competitiveness of EC member states Part 10 – Green VAT for business
Enhance the competitiveness of EC member states Part 11 - Keep talents in Europe
Enhance the competitiveness of EC member states Part 12 - Research leftovers
Enhance the competitiveness of EC member states Part 13 - Science Parks-Specializations
Enhance the competitiveness of EC member states Part 14 - Patent trolls
Enhance the competitiveness of EC member states Part 15 – Science e- Parks
Enhance the competitiveness of EC member states Part 16 – Expansion options (In progress)
Enhance the competitiveness of EC member states Part 17 – The locally developed infrastructure
Enhance the competitiveness of EC member states Part 18 – Treaty (Knowledge transfer)
Enhance the competitiveness of EC member states Part 19 – Different types of infrastructure
Enhance the competitiveness of EC member states Part 20 – Build infrastructure (In progress)
Enhance the competitiveness of EC member states Part 21 – Your small energy infrastructure (elsewhere) (In
progress)
Enhance the competitiveness of EC member states Part 22 – Quick market entry (Medical)
Enhance the competitiveness of EC member states Overview – Old and new key areas in order to increase the
competitiveness of the industry (In progress)
Input on threats against information society

Quick market entry (medical)

Recommended

Recommended

More Related Content

More from Somerco Research

More from Somerco Research (20)

Recently uploaded

Recently uploaded (20)

Quick market entry (medical)