Regulatory control for food safety: Meeting the needs of competitive - - PowerPoint PPT Presentation

Regulatory control for food safety: Meeting the needs of competitive innovation and consumer protection.

Ian Urquhart

Director: Regulatory Affairs 1

Agenda

• 1. Innovation‟s contribution to consumers
• 2. From foods to pharma – a perspective of risk / benefit
• 3. How risk assessment and management practices are sometimes

perceived

• 4. Ideas / examples for good practice

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The GSK India product portfolio

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Helping people to do more, feel better, live longer

Profit Year 2 4 6 Contribution to profit from Product A B C D E Total Profits Profit from products A to E Profit required from Innovation

Innovation is the lifeblood of any sustainable business

Innovate or decline … and for Fast Moving Consumer Goods … Innovate fast

Great innovation has delivered a diverse range of food products to Indian consumers; the processed food industry has grown dramatically

The majority of responsible food business operators want do the right things, and do things right - to retain consumer trust

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Innovation Space™

Consumer/user needs & segments Political, regulatory & environmental factors Manufacturing, process + sourcing distribution Competitors & competing technologies Channels & countries Business models and value drivers Brand proposition & story Products technology & IP

Innovation Space is a trade mark of Viadynamics Ltd www.viadynamics.com

Innovation needs to operate in an environment that does not treat all risks as equal – because they are not ….

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Drugs – therapeutic window, adverse side effects, treatment / cure of disease; “consumed” for therapy Food – important nutrients, maintenance

• f healthy

lifestyle, history of safe use, frequent consumption for nutrition / pleasure Borderline between foods / medicines

Trust = Management / Control Risk

Borderline between Cx / Rx medicines Consumers Patients Consumer Self-selection

• r OTC

Necessary for life; risks associated with environment and frequency of consumption Track record

• f safety –

risks do exist Benefit

• utweighs

detriment

Many positive examples of proportionate control systems in many countries - that help deliver innovation

• 1. Shift in international food control systems from „command

and control‟ to systems based on risk analysis and prevention

• 2. Move away from emphasis on end product inspection,

approval and testing to preventive control of hazards and implementation of certification systems

• 3. Regulators implement preventive systems based on

scientific evidence of unacceptable health risks, and mandate application of preventive programmes (such as HACCP).

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Inappropriate risk assessment and management practices can undermine the trust of the key stakeholders

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Too slow; not time bound; delays Lack of clear requirements No opportunity for dialogue; to explain and listen Treat all risks the same; with the same priority No transition periods for change; high costs of rework Don‟t deal with non- compliance; no level playing field Not focused on the science; emerging risks Not another food scare ….. ! Who can I trust ?

The negative impact of inappropriate control on competitive innovation and risk management is substantial

• 1. Resources focused on treating all ingredients / products as the same

risk can dilute valuable resource - away from the high risks

• 2. Unresponsive management practices run the risk of being perceived

as

• Burdensome
• Inefficient

to the needs of a rapidly changing global environment – to deal with emerging risks and consumer demands

• 3. Regulatory control systems are a factor in commercial strategies and

investment decisions

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What risk management strategy would help deliver fast sustainable innovation in India ?

Avoiding these potential issues … And leveraging ... Poor perceptions (or realities) of the process Shared values (focused on consumer protection) Lack of harmonisation International best practice Lack of clarity / certainty Science & technology

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to retain the trust of consumers and all process stakeholders

Perhaps the strategic answer is …

• 1. Not only about what you choose to do, but also about what

you choose not to do …

• 2. Recognition that each stakeholder delivers a unique set of

“services” …. What “attributes” valued by consumers / citizens are unique to your organisation ?

• Innovation – Industry
• Risk assessment – Scientists
• Risk management – Regulator
• Enforcement System – Courts, etc.
• 3. Communication between stakeholders helps to deliver a

proportionate management system

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Some characteristics of risk management system to deliver quality, safety & rapid innovation

• Certify a business to manufacture (or import) a certain class of

product

• Limited regulator intervention with well-established safety

In the event submissions are need to assess novel (ingredients, technologies)

• Efficient handling of assessments
• A predicable regulatory environment – type of data, review

timings

• Clear process for interactions & “stop the clock” procedures
• Dialogue / guidance before, during and after assessment

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Even the drug processes are proportionate, and use clear guidance, dialogue and targets to help deliver efficient innovation

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• Clear guidelines (ICH)
• Pre-submission meetings
• Targets for New Drug

Application reviews

• Use of abridged

applications

• Clinical and Toxicological

testing is frequently waived for generic active ingredients

• OTC status for

molecules with well established safety

Pre-IND

Synthesis and purification Animal and laboratory testing

Pre-IND agency meeting

IND phases

Clinical Phase I Clinical Phase II

End of Phase II Agency Meeting

Clinical phase III

Pre-NDA agency meeting

NDA Review and Approval Post Approval – Phase IV clinicals

IND submitted

NDA submitted

The Pharmaceutical Product Lifecycle

What helps in the drug approval process?

Conclusion

• 1. We share the same values
• 2. Change is certain – innovation responds to unmet

consumer needs and drives change

• 3. “How” to manage risk is context specific – regulator

approaches from elsewhere can be positive or negative – no single attribute (or set) makes a process work

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