Annual General MeetingTuesday, 28th April 2009

Meeting the Meeting the Challenges of 2009 Challenges of 2009

and beyond... and beyond...

MY PRESENTATION TODAY:

1) The HFMA – some background

2) What are the challenges?

3) How do we confront and combat

them?

4) Conclusions

WHAT IS THE HFMA? The voice of the UK’s Natural Products

industry The most representative trade body in the

UK, founded in 1965. Currently around 125 members

Founder member of EHPM, the European Federation of Health Product Manufacturers

‘WHO’ IS THE HFMA?HFMA Council – 2009/10:

Represented by:Gert Krabichler Dominic HolmesJonathan ShortsRoger CraddockJohn Redman Janet Groves Martin Last Lynn LordTom Moses Robert Taylor Ivor HarrisonTim Snook

Company:Capsugel CressGee LawsonHolland & BarrettLamberts Healthcare G R Lane MPL MarketingNatures AidReaction Sales CL UKVitabioticsWilliam Ransom Wassen

HFMA Secretariat:Executive Director: Graham KeenSpecial Projects Director: David AdamsOffice Manager: Linda Phillips

LAPADCode Administrator: Gwyneth MasseyCode Administrator: Jenny Akers

Advisers:Technical: Michael EvansScientific: Dr Michele sadlerParliamentary/Political: Chris WhitehousePR: Pegasus PR

Officials:President: Peter AldisVice-President: Penny viner

Expert Panel:Dr Marilyn Glenville PhDProfessor Andrew LoteryJayney GoddardDr Adam CareyPatrick HolfordDr Rob Hicks

SO WHAT ARE THE CHALLENGES? Regulatory Issues

Getting the rest of Europe up to speed!

Combating negative media

Getting our Officials to fight harder on our behalf

Maintaining a united front

SO WHAT ARE THE CHALLENGES? Regulatory Issues

Getting the rest of Europe up to speed!

Combating negative media

Getting our Officials to fight harder on our behalf

Maintaining a united front

ISSUES

FSD CLAIMS

HERBALS UIC

PROGRESS IN 2008 MPL’s – HFMA lobbying, using impact data

and legal arguments, helped delay EU proposals

Claims – HFMA supported 776 pan-EU claims

Herbals – Steady increase in THMPD applications & recognition by EFSA that the ‘Botanicals’ category exists

UIC – Guernsey introduced new Medicines law, Jersey committed to implementing legislation

STILL TO FIGHT MPL’s - Commission favours political

compromise & UK ‘sacrifice’ Claims – Chronic lack of clarity on several

issues & criteria for assessment by EFSA Herbals – THMPD barriers to entry for

SME’s (cost) = reduced consumer choice & Botanicals meeting NHCR criteria for making claims

UIC – Enforcement is required to ensure effectiveness of new laws

SO WHAT ARE THE CHALLENGES? Regulatory Issues

Getting the rest of Europe up to speed!

Combating negative media

Getting our Officials to fight harder on our behalf

Maintaining a united front

PRThe perpetual dilemma: Reactive vs proactive?

Proactive PR needs quality ‘ammunition’: The IADSA/EHPM Scientic Network initiative

SO WHAT ARE THE CHALLENGES? Regulatory Issues

Getting the rest of Europe up to speed!

Combating negative media

Getting our Officials to fight harder on our behalf

Maintaining a united front

IMPACTING BRUSSELS: DG meetings MEP consultations National Permanent Representatives Commission processes e.g. Petitions Pre-election lobbying (see the HFMA’s latest

toolkit)

Key point to remember – Brussels is currently fixated on SME impact

SO WHAT ARE THE CHALLENGES? Regulatory Issues

Getting the rest of Europe up to speed!

Combating negative media

Getting our Officials to fight harder on our behalf

Maintaining a united front

HOW DO WE DO THIS?

A concerted campaign: Face-to-face meetings/telephone updates

(during our recent MPL’s campaign we met with the Health Minister, Defra, BERR, FSA, along with DG SANCO, DG Enterprise, MEP’s and the UK Perm Rep)

Parliamentary briefings Briefing papers

Remember - they need our help to properly fight our case...

SO WHAT ARE THE CHALLENGES? Regulatory Issues

Getting the rest of Europe up to speed!

Combating negative media

Getting our Officials to fight harder on our behalf

Maintaining a united front

A UNITED FRONT Consumers

Retailers

Other national associations (where we have agreement and consensus)

A lead role within Europe

Our closest ally in Europe

FUNDAMENTAL PRINCIPLES:

“The four tenets of safety, sound science, proportionality and consumer choice must

be the basis in future upon which regulation is founded”

John Redman, HFMA Chairman – 6/4/09

THE KEY MESSAGE: Over-regulation risks suffocating a responsible and

innovative sector that is populated predominantly by small and medium sized enterprises

Over-regulation risks driving consumers to the grey and unregulated markets of the internet and offshore suppliers, ironically reducing not enhancing consumer protection

Over-regulation of the self-care sector risks impacting upon public health and increasing the burdens on the Health Service Executive/National Health Service

Over-regulation brings the European Commission into disrepute and does a disservice to the people it serves

IN CONCLUSION...

We cannot duck these challenges!

There is not a part of our industry that will not be impacted by over-regulation

This will not be easy – we are only 2 members out of a club of 27...