Vincintori MUHAMMAD FAUZI WIBISONO LEONARD OCHIENG XUEYUN ZHOU

Vincintori MUHAMMAD FAUZI WIBISONO LEONARD OCHIENG XUEYUN ZHOU LORENZO VALERIANI

Fitness Genes What are they doing? What is the problem?

The current market Internet-Based Direct-to. Consumer Genetic Testing Business to business model Small/medium fitness operators: • Personal Trainers • Gyms Wellness and insurance corporations

Legal Perspective of B 2 C o. Legal issues on DTC generic testing o. Advertising restriction o. The new EU's IVD (In-Vitro Diagnostics) Regulation o. Ban on DTC advertising o. Its effects on marketing strategy o. Option

Legal framework issues under discussion Current legal framework governing the use of DTC genetic testing within UK , EU and USA The proposed legal framework governing DTC genetic testing within EU. Its effects to the market strategy The way forward

Legal framework governing the use of DTC genetic testing within UK. EU and USA DTC genetic testing has become a popular business model used by companies who are looking for ways of expanding the market for genetic tests. This done by selling genetic testing to consumer directly via the internet. However there are currently no general restrictions under UK and EU legislation on the marketing of CE marked IVDS directly to consumers.

Advertising restrictions Companies marketing diagnostic screening tests should be very careful with advertising claims to ensure they comply with the applicable rules in the country where consumers will be targeted. For example, in USA, there is a legal framework in place following the decision by the US Federal Drug Administration (FDA) to crack down on misleading claims made for genetic tests in late 2013. another example of a country has put restrictions is Germany. Even if the website advertising the DTC genetic test includes some form of disclaimer , a regulator is likely to regard the provision of the information directly to consumer as de facto provision of medical information and so will treat the testing kits as an IVD.

The new EU's IVD (In-Vitro Diagnostics) Regulation If this new directive is adopted, it will require companies to provide clinical evidence to support the claims they make. This means that they will either have to employ a physician or partner with medical health service provider.

Ban on DTC advertising The directive has propose a ban on the DTC advertising of devices for genetic testing. They are proposing that a device may only be used for the purpose of a genetic test if the indication is given by a person admitted to the medical profession after a personal consultation. This is a material development and it would serve to seriously constrict markets access for the majority of genetic testing companies who currently offer some form of DTC services

Its effects on marketing strategy This ban mirrors the strict requirement in the EU Pharmaceutical legislation. If this proposal is carried into legal text then its implication is that companies would have to reevaluate their commercial approach because they would no longer be able to legally target EU consumers by advertising and selling genetic screening directly to them.

The Problems (What? And Why? ) o To B 2 B o Advantages : 1. Marketing: New partner that have bigger numbers of customer Brand Awareness increased and minimize the gap from early adopters to the early majority consumer 2. Finance: Increase the Revenue Stream and Investors trust Operation and Investment 3. Product and Service: A lot of data for research activities can be obtained Improve the quality and accuracy of product and service o Disadvantages: (Involvement in product development, focus will be divided, high risk (marketing) and need more effort)

The Problems (Capability of Your Firm) Finance: Limited Marketing: Capable Research and Development: Capable Team or Human Resources: Limited Legal Aspect: Limited

Solution Health Insurance Companies

Solution Fitness Organisations

Wellness Companies

Participants in the Technology Adoption Life Cycle Revenue growth Late Majority, Conservatives Early Majority, Pragmatists Early Adopters, Visionaires Laggards, Skeptics Innovators, Lead Users LU EA EM LM La Time

Conclusion 1. 2. 3. The Problems 1: Fitness Genes product and service has a big gap between early adopters and early majority in Technology Adoption Life Cycle The Problems 2: Whether stay in B 2 C or try to expand to B 2 B model? What to prepare? Solutions: Go expand to B 2 B model, but set up some preparation first Because, B 2 B offer a lot of advantages to the development of your firm, but it come with high risk