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  • 7/25/2019 Conference Report AESGP Annual Meeting 2016 Athens

    1/22

    Launch of the AESGP

    Self-Care Agenda 2020

    As AESGP President, Roger SCARLETT-SMITH in-troduced the AESGPs new Self-Care Agenda 2020

    which primarily addresses unnecessary restrictions

    currently placed on developing self-care in Europe.

    He outlined that industry had the opportunity to

    give millions of people across the European Union

    safe and effective access to self-care but for this to

    happen there was a need for improving the regula-

    tory system. People want to take responsibility for

    their own health and this, combined with demogra-phic changes and the increasing cost of professio-

    nal healthcare, means more must be done to deve-

    lop and support self-care.

    To achieve greater self-care in Europe by the year

    2020, the AESGP Agenda puts forward six

    enablers: establishing evidence-based policies, fos-

    tering enhanced cooperation between all stake-

    holders, creating more incentives for innovation in

    self-care, reducing administrative burden, using

    procedures for market access efficiently and imple-menting existing rules reasonably.

    Self-Care Agenda 2020

    The Self-Care Agenda 2020 summarises the

    objectives of AESGP for the years to come in

    the area of non-prescription medicines, food

    supplements and medical devices.

    It focuses on areas where through a re-

    duction of the regulatory burden, the availa-

    bility of self-care products can be improved.

    1

    Conference report

    The future of self-care:Shaping the new environment

    The AESGP 52nd Annual Meeting - the annual gathering of the self-care sector in Europe was held in

    Athens, Greece, from 31 May -2 June 2016. Entitled The future of self-care: Shaping the new environment,

    the conference looked at this overarching theme from three angles: marketplace, regulation and policy cove-

    ring non-prescription medicines including herbal medicinal products - food supplements and self-care me-

    dical devices. With more than 350 participants, including representatives from industry, and many stakeholder

    organisations, the conference was once again very well attended.

    http://www.aesgp.eu/media/cms_page_media/68/AESGP%20Self-Care%20Agenda%202020.pdfhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%20Self-Care%20Agenda%202020.pdfhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%20Self-Care%20Agenda%202020.pdfhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%20Self-Care%20Agenda%202020.pdfhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%20Self-Care%20Agenda%202020.pdfhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%20Self-Care%20Agenda%202020.pdfhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%20Self-Care%20Agenda%202020.pdf
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    Nicolas Bouzou

    Roger Scarlett-Smith

    In a fast-changing and global environment, it is im-perative that the regulatory system be fit for pur-

    pose, efficient and risk-based whilst ensuring opti-

    mum public health protection. Any formal evalua-

    tion of a regulatory instrument should include the

    different actors involved (e.g. regulators, industry,

    patient organisations, healthcare professionals). It

    should also include feedback loops to ensure that

    the instruments continue to operate well and re-

    main fit for purpose.

    There is an availability issue with non-prescriptionmedicines in Europe. It is shocking that only five

    ingredients were available as non-prescription me-

    dicines in all EU Member States. The routes to mar-

    ket (centralised, mutual recognition, decentralised

    and national procedures) need to guarantee timely

    market access for non-prescription medicines inclu-

    ding reclassification from prescription to non-

    prescription status (switch). The benefits of non-

    prescription medicines need to be taken into ac-

    count in the evaluation process e.g. through the use

    of recognised risk-benefit decision making models.It is now important to put the general political

    orientations into real action through switch gui-

    dance, transparent criteria and open cooperation. It

    is vital that applicants continue to have the ability to

    choose for well-established substances which

    procedure they wish to use (European or national).

    Also, the implementation of the new EU pharmaco-

    vigilance legislation must reduce unnecessary admi-

    nistrative burdens and avoid unjustified restrictions

    for non-prescription medicines.

    Having the host country in mind and quoting, the

    Commission at the 2007 EU Pharmaceutical Forum,

    Roger Scarlett-Smith said that Price control is not

    necessary for non-reimbursed medicines. For these

    products, price competition can steer the price evo-

    lution sufficiently well. Therefore, Member States

    should abstain from price-control. This principle

    must be adhered to in all Member States. He added

    that AESGP acknowledged the high value of infor-

    mation to consumers to assist them in selecting ap-

    propriate treatment, to communicate benefit, quali-ty and promised experience and to establish trust

    and confidence. So let's learn, get inspired, get in-

    volved and take action early to secure the benefits.

    New technologies as a possible curefor healthcare systems

    According to Nicolas BOUZOU, founder and direc-tor of Asters, the healthcare battle is a great way

    to reconcile European citizens with scientific innova-

    tion because it can help solving human issues. The

    Welfare State has been shaping the life of European

    people. But the economic and technological envi-

    ronment has been changing quickly while the Wel-

    fare State is difficult to reform. European citizens are

    getting older. Health expenses increase because of

    the impact of chronic diseases like diabetes or can-

    cer. Health expenditures are rising very quickly in

    nearly all rich countries. Health is what economists

    call a superior good, namely a good whose weight

    in private incomes is rising.

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    Erica Mann

    The more medicines that are developed, the more

    the R&D costs increase and with it the price of new

    treatments. This is part of our common value to

    make all European people access the most adapted

    treatments whatever their revenues are, hence the

    necessity to regulate the price.

    Bouzou insisted that health systems had to be re-

    formed under two constraints: public expenditures

    must be regulated (no more tax increase possible)

    and justice as conceptualised by Plato must be

    given a prominent place. In the EU, the idea of

    justice is embedded in the healthcare systems ai-

    ming at allowing people to build up their own life.

    With regard to new technologies, the changes we

    are experiencing confirm the economists renowned

    theory that Joseph Schumpeter defined as creative

    destruction in 1940: progress is made by des-troying the past. Instead of digitalisation, Nicolas

    Bouzou prefers to use the term NBIC which stands

    for Nanotechnology, Biology and medicine,

    Information sciences, and Cognitive Science. This

    evolution is a four-step process which started with

    digitalisation, i.e. converting information into a

    digital format (in the 90s).

    The second step is uberisation, i.e. digitalisation of

    services (ongoing), followed by the Internet ofThings, i.e. the network of physical objects embed-

    ded with electronics, software, sensors, and network

    connectivity that enables these objects to collect

    and exchange data (starting). The last step that can

    already be anticipated is transhumanism, i.e. evo-

    lution of the human race beyond its current physical

    and mental limitations. Bouzou explained that the

    introduction of new technologies and notably the

    internet of things in the health field was accompa-

    nied by the arrival of new players who contributed

    to the development of a new ecosystem. The datadeveloped by these players can greatly help in

    patient monitoring and better prevention so as to

    allow a better regulation of health expenditure.

    An insight into Bayers strategicthinking

    Erica MANN, Worldwide President of the Bayer

    Consumer Care Division, calls the self-care industryto look up and build the infrastructure to meet

    consumers needs or risk losing them. Recalling that

    this industry is deeply rooted thanks to the support

    of generations of family trust, Mann asked if its

    relationship with consumers was as good as it

    could be, should be. We need to move our rela-

    tionship from simply providing information to advo-

    cacy. Industry has to ask itself whether it supplies

    the right information, and whether it has invested to

    build the infrastructure that would enable consu-

    mers to access all the information needed to choosethe right product. A 2013 quantitative study showed

    that only 20% of consumers feel very confident in

    managing their own health. This points to a pivotal

    role for health literacy to provide the knowledge,

    capacities and skills to practice self-care.

    In response to that, Mann said that the self-care

    industry needed to be the difference and become

    the creative force or the connectors to foster this

    digital entrepreneurship. Reminding that E-

    commerce is growing in every retail market sectors,she warned that industry would lose in the digital

    space if it did not invest in the right infrastructure,

    noting that high-profile technology companies such

    as Nokia, Google and Samsung have already inte-

    grated healthcare applications that enabled consu-

    mers to see all health data from multiple sources inone place. Consumer power fused with consumer

    knowledge will create a new breed of consumers.

    Mann concluded: I urge all of us to look up and

    lets get a bit of this rather than being overrun by it.

    Lets be the difference.

    Conference report

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    Big becoming bigger:Mergers and Acquisitions(M&A) in the consumer

    health and pharmaceuticalindustry

    Are the big really becomingbigger? Global OTC Market Trends

    Francine NIETO, Global Offering Director, at IMSHealth,

    provided an insight into the performance of

    the worldwide OTC market. Although the OTC mar-

    kets steady growth continues and should continue

    to do so in the next few years (by an expected rate

    of 5%), it remains only 10% of the total global

    pharma market. Specialty drugs (in oncology and

    hepatitis) notably in US are driving the market. OTC

    is still a very attractive 95 billion euro market for

    2015. Over 60% of the market growth is generated

    by China, Latin America, Turkey, Russia, and Middle

    East.

    According to Nieto, there is no doubt that the

    biggest are definitely getting bigger. The top 3

    corporations in the global OTC rankings increased

    by 15%, however the gap between the first and 10th

    -placed companies continues to grow.

    The 10th-placed firm had a 1.7% share in 2005, but

    the leading player had only a 4.5% share, a factor of

    2.6. In 2016, the 10th-placed firm has a 1.3% share

    but the leading player has a 5.2% share, a factor of 4

    -times more.

    While the small ones are also still growing (notably

    in the developing regions), middle players are get-

    ting squeezed in-between. Nieto explained the

    growth in the Australian market as mainly resulting

    from export to China using the good image ofAustralian consumers. The top 10 players need to

    look for mergers and acquisitions to grow. Among

    200 companies, there are not so many global corpo-

    rations. The average growth rate of global compa-

    nies has only been 3.6%. Local/regional players have

    grown faster at 4.3%; while multi-regional firms

    have achieved an average increase of 3.8%. Overall

    global OTC growth has been 6.1% in 2015, demons-

    trating the strength of smaller players.

    Nieto concluded that players coming from outsidethe OTC market were looking to join in and

    potentially might decide to get bigger. Technology

    players are also looking to be part of the game.

    Market leadership is consistently changing and

    there are faster regional players engaging in merger

    and acquisition activities.

    Francine Nieto

    Making bigger mean better

    Presenting the new GSK Consumer Health created

    in March 2015 from consumer health care joint

    venture GlaxoSmithKline (GSK) and Novartis, BrianMcNAMARA, Head of Europe & Americas at GSKConsumer Healthcare, believes speed and culture

    are critical when tackling a merger.

    Referring to a KPMG study which indicated that

    83% of mergers could be regarded as failures to

    enhance shareholder value, he described the most

    important driver of success for a deal. First and

    foremost, for GSK, the strategic rationale for deal

    was clear and had four major areas of focus:

    Strengthen 3 core businesses for GSK

    1) GSK acquired the Novartis vaccines business

    2) GSK sold some oncology assets to Novartis

    3) GSK and Novartis created Consumer

    Healthcare joint venture

    Create a business with key category leadership

    positions based on highly complementaryportfolios

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    Brian McNamara

    Give more competitive geographic footprint by

    scaling in OTC at country level going from #1

    position in only 13 markets to 30. Emerging

    markets now account for 40% of GSKS portfo-

    lio.

    huge synergy potential including both revenue

    and cost synergies (400 million of cost syner-

    gies by 2017)

    McNamara stressed that the initial focus in any deal

    was integration the first few steps in a long jour-ney. Starting with setting the strategy (Where to

    Play and How to Win), the team needs then to be

    built up regrouping talents from both sides. The

    systems integration is next for achieving one or-

    der, one invoice across markets (in over 100 mar-

    kets). He was happy to say that no major disrup-

    tions had occurred yet. Last but not least, according

    to McNamara, culture is critical. Quoting Peter

    Drucker who said culture eats strategy for break-

    fast, he insisted that building right culture for new

    company was a key enabler of GSK CHs success.

    But integration is only the beginning; real challenge

    is creating sustainable long-term value: for consu-

    mers, customers and shareholders. For consumers,

    this means getting the right product, to the right

    consumer at right time notably by accelerating

    innovation, expanding access to self-care and build

    trust in their brands. He concluded that the overar-

    ching critical factor in merger success was speed. In

    doing so, GlaxoSmithKline (GSK) has achieved 6%

    top-line growth and a 180 basis-point impro-

    vement in its operating margin. Noting the strong

    Year 1 financial results and performance in the

    market, McNamara acknowledged that there was

    still a long road ahead.

    Sanofis journey in an ever moreexciting environment

    According to Vincent WARNERY, Senior VicePresident, Global Consumer Health Care Division,

    Sanofi, it is crucial not to give an acquired com-

    pany a "cultural shock". Sanofi Consumer

    Healthcare used a smart integration model when

    it acquired Chattem in the US in 2010, and will do

    the same later this year when it will merge withBoehringer Ingelheims OTC business. This ap-

    proach was behind the decision to maintain Chat-

    tem as a separate operating unit in its existing

    Chattanooga, Tennessee headquarters. Warnery

    insisted that Sanofi learnt from its failures notably

    from past acquisition of the wrong targets. In that

    regard, Oenobiol is a good example of failure (key

    talent loss, erosion of the fast-cycle innovation

    culture, agile marketing, regulatory and medical

    CHC capabilities loss etc).Having now sold Oeno-biol to Vemedia, Warnery appeared confident that

    it would be a greater success.

    Regulatory expertise to switch Allegra

    (fexofenadine) in the US has been provided by

    Sanofi but no staff had been lost from Chattem,

    and in some respects the Chattem integration

    represented a reverse takeover. He indicated

    that the same approach would apply to Boehrin-

    gers OTC operations in Germany.

    The merger as a whole with Boehringers OTC

    represents a natural cultural fit as both compa-

    nies have a similar market approach.

    Vincent Warnery

    Conference report

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    An insight into Johnson & Johnsonsstrategic thinking

    Birgit SCHUHBAUER, Global Vice President, Strate-

    gic Marketing OTC at Johnson & Johnson, madeclear that in all integrations the people question is

    the tough one. Each company leads its merger and

    acquisitions differently but it is all about clarity and

    speed. Organisational charts need to be in place

    soon after an acquisition is agreed and the new

    structure needs to be quickly communicated to

    employees, informing them of their job status.

    When people dont know what their future is, they

    are blocked. Although there is a lot of under-

    standable fear amongst staff during the merger

    process, such activities create larger companies and

    offer more cross-category opportunities. Mergers

    do not fail because the assumptions and the strate-

    gy are wrong; they fail for culture and change-

    management reasons.

    Smaller acquisitions must not be underestimated

    because they can also create more value with exist-

    ing assets. Referring to Johnson & Johnsons acqui-

    sition of Indian Orsl, an electrolyte drink that is

    recommended by healthcare practitioners,Schuhbauer demonstrated that smaller acquisitions

    might allow developing the relationship with

    healthcare practitioners, which was of primary im-

    portance in emerging countries. External growth is

    definitely Johnson & Johnsons big strategy as

    merger and acquisition are in the companys DNA

    but it has to be the right fit.

    Session Chair Babis PAPADIMITRIOU, a well-known journalist in Greece, concluded that M&A

    activities do not seem to have reached its end point

    and wondered how the market will look like in a

    decade from now.

    Birgit Schuhbauer

    Babis Papadimitriou

    Boehringer has a perfect portfolio, 15 brands in four of Sanofis six priority categories and the merged entity

    would be in the top five in the worlds 11 leading markets, including Japan and Greece. Warnery recognised

    the great achievement of Boehringer.

    Warnery highlighted two key factors of Sanofis future business model for growth. First, striking strategic

    partnerships with prescription brand firms to fuel OTC switches is vital, noting Sanofis deal with Eli Lilly over

    the erectile dysfunction drug Cialis (tadalafil). Secondly, "swap transactions" for brands or even whole portfo-

    lios will be key to create a win-win situation and to address 2 in 1 strategic objective. In conclusion, Warnery

    confirmed Sanofi is highly motivated by the OTC market.

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    Key elements to make pro-gress for self-care in reality

    Chair Suneet VARMA, President and General Mana-ger at Pfizer Consumer Healthcare, introduced the

    session in which speakers presented case studies in

    three different countries on how to really improvethe availability of non-prescription medicines.

    Manifest for the development ofself-care in France

    Pascal BROSSARD, President of the French industryassociation (AFIPA), presented AFIPAs recommen-

    dations to promote the development of self-care -

    and in particular, self-medication in France and

    promoted the inclusion of the health care reform inthe political debate ahead of the 2017 national

    elections. France lags behind in the use of self-

    medication, which represents 15.4% of the volume

    of the French medicine market versus 32.3% on

    average in Europe. Afipas objective is to demons-

    trate that the French people are ready to practice

    self-medication and that the GPs are willing to

    support them in this practice. A recent study con-

    ducted on both patients and doctors has shown that

    nearly all French people questioned (91%) feel they

    are able to deal by themselves with minor healthissues. 80% of them have practiced responsible self-

    medication to treat benign symptoms over the past

    year. 92% of the people questioned indicate that

    their symptoms disappeared without their having to

    consult a doctor. According to the GPs themselves,

    16% of the patients they see in consultations could

    be treated by responsible self-medication. The GPs

    also state that the development of responsible self-

    medication could de-saturate their offices (59%),

    reduce health spendings (53%) and enable them to

    re-focus on more severe health issues (63%).

    Afipas manifest recommends an action plan to

    develop self-care in France to benefit all actors of

    the health care system:

    Reform the financial coverage and develop the

    self-medication medicine offer: The reduction of

    the public financing for 201 molecules, corres-

    ponding to 66 self-medicatable indications,

    would provide savings exceeding 1.5 billion

    euros during the very first year.

    Associate health care professionals and patients

    to this new health care strategy. With this ap-

    proach, self-medication will become the firststep of the health care process, based on well-

    informed, autonomous patients and perfectly

    trained health care professionals.

    Facilitate self-medication and ensure it is finan-

    cially accessible in order to obtain patient sup-

    port:

    In France, everything is ready to increase the deve-

    lopment of self-care rapidly: the patients, the health

    care professionals, the distribution and control net-

    works The only missing factor is a strong politicalwill to place self-care at the heart of a new health

    care strategy. The lack of political anticipation on

    these issues is difficult to understand. According to

    Brossard, we must react and adopt an approach

    which works everywhere else in the world. He con-

    cluded that Afipa was ready to support any political

    action aiming to develop self-care.

    Suneet Varma

    Pascal Brossard

    Conference report

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    Addressing the sustainabilitychallenge of Healthcare SystemsThe vital role of Self-Care An example from Germany

    Dirk OSSENBERG-ENGELS, Head Region EU South,

    CEE & ME at Bayer Consumer Health, said withconviction that self-care is the right thing to do.

    To accomplish self-cares full potential a joint dis-

    cussion of all policy-makers and stakeholders is

    needed which looks at both public health and long-

    term sustainability of health care systems. Self-care

    can help consumers to get well and stay well

    through fostering self-care literacy and enabling

    consumer empowerment if appropriate access and

    availability of current and future OTC medicine are

    guaranteed. Self-medication is an important pillar

    of the German healthcare system.

    Focusing on the importance of headache, he men-

    tioned the 2010 consumption data of OTC-

    analgesics per capita that showed a rather minor

    consumption of OTC-analgesics in Germany com-

    pared to other countries such as France. Bayer

    Consumer Health Division has undertaken a study

    on how much self-care treatment of migraines with

    OTC analgesics had saved the German healthcare

    system annually. The study based on a representa-

    tive, independent survey of persons insured by aStatutory Health Insurance investigated the value of

    self-medication and found that switch to self-care

    for this one indication saved 1 billion a year."

    Ossenberg-Engels concluded: That is one indica-

    tion in one country; think about the saving if it was

    Europe-wide.

    Dirk Ossenberg-Engels

    Key Elements to Make Progress forSelf-Care in Reality

    According to Karen PROUD, President of Consu-mer Health Products Canada, building the evi-

    dence base is key to prevent a slow-down in re-

    forms to consumer healthcare rules in Canada. InJune 2014, Health Canada announced a consulta-

    tion on a Framework for Consumer Health Products,

    which proposed to modernise the oversight of

    health products, intended for consumer use. Using

    concrete examples of borderline products, Proud

    explained that consumer health products covered a

    broad range of products including cosmetics (e.g.

    make-up, deodorants), disinfectants (e.g. for use on

    countertops, contact lens solution), non-

    prescription drugs (e.g. pain relievers, cold and al-

    lergy remedies) and natural health products (e.g.vitamin and mineral supplements, traditional and

    homeopathic products, toothpastes). The 2015 Ca-

    nadian election gave a strong majority to the libe-

    rals who swept into power and changed the game

    players. While the reform of consumer healthcare

    rules remains a priority of the new government, this

    government contains numerous rookie politicians

    who have no knowledge of the consumer

    healthcare space. In response to that, Proud pro-

    moted three key elements: raising awareness, edu-

    cating the willing and driving for change. The Asso-ciation is developing a study, similar to Bayers stu-

    dy in Germany, outlining the benefits to consumers

    and the Canadian healthcare system of supporting

    prescription to over-the-counter switch initiatives.

    Karen Proud

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    CHP Canada is working with pharmacy regulators to ensure that self-care remains the first response to

    health care and has launched communication campaigns to the public. CHP Canada has been spreading

    the word self-care and is working with Canadian politicians to increase awareness among Canadian offi-

    cials of the value of formally recognising self-care as a primary component of the healthcare system and

    providing the resources necessary to support the efforts of its citizens to practice responsible self-care.

    Concluding on the session, Chair Suneet VARMA reminded that the true value of self-care needs to be

    shown to policymakers, health insurances, consumers and the like, and while we say this every year, the

    time is now to demonstrate the benefits.

    Getting full support for self-care from stakeholders

    In his introduction, the session Chair George DOKIOS, Director General, EFEX, stressed that stakeholdersin many parts of Europe needed to recognise the benefits of self-care. While stakeholders in markets like

    the UK have already embraced the self-care concept, others in countries like Greece have only just started

    to grasp the benefits. Self-care needs a coordinated support by all stakeholders. Noting that new laws in

    Greece are bringing radical changes to the Greek pharmaceutical market, he said that any process of

    change following major economic difficulties had implications on healthcare in general as well as on

    healthcare professionals, including in particular community pharmacists.

    Portugal Self-Care Program Takecare of myself

    According to Mafalda ARAJO, Vice President ofAPIFARMA / OTC, Portugal, developing Portugalsself-care publicity campaign has brought all of the

    stakeholders together for the first time. She ex-

    plained that the key objectives for this campaign

    had emerged from stakeholders consultation

    aiming at: empowering the Portuguese popula-

    tion to manage minor health problems, promo-

    ting healthy behaviours and the responsible use

    of OTC medicines, actively contributing to health

    literacy in Portugal and ensuring the involvement

    of health professionals and educators in a natio-

    nal program. Choosing an accessible language for

    the consumers, the association went for the brand

    Tratar de mim meaning I take care of myself.

    Arajo highlighted that the whole process started

    in Lisbon 2013 at the AESGP conference which

    raised awareness and interest from stakeholders.

    Although bringing together doctors and pharma-

    cists in partnership around self-care was a chal-

    lenge, the program was officially launched in July

    2015 with a poster and two leaflets published and

    distributed to pharmacies & health centers. Face-

    book was a key tool in this campaign as it allows

    for speed and flexibility by contrast with leaflets

    and factsheets. Since its launch, the programme

    has been extended with a childrens game called

    Learning about health is fun and a self-care

    conference is also planned for the autumn 2016.

    Mafalda Arajo

    Conference report

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    Efficient OTC Self-Care in GermanPharmacies

    Michael BECKER, Deputy Chairman of the Ger-man Medicines Manufacturers Association (BAH)

    put forward that combination of OTC and strong

    pharmacies were key factors for an efficient publichealthcare-system. Having presented the product

    classification and distribution channels in Germa-

    ny, Becker indicated that 4 million German consu-

    mers went in pharmacies every day, 70% of them

    going to their local pharmacy. There are more

    pharmacies in Germany than bakeries and gas

    station, i.e. more than 20,000 pharmacies. Looking

    at the number of pharmacy per inhabitants, Ger-

    many has 4.000 inhabitants per pharmacy which,

    compared to Greece, does not appear so high

    (1.000 inhabitants per pharmacy in Greece). No-ting that 95% of internet enquiries refer to di-

    seases and symptoms, Becker insisted on the

    need to have fast, reliable and local expertise at

    hand.

    In many cases, the pharmacist appears as the first

    point of contact to provide trust and advice.

    Sale of OTC in pharmacies enables more efficient

    patient care and will lead to change in behaviour

    and awareness of all involved stakeholders in the

    healthcare environment. Becker concluded that

    OTC and pharmacies were strongly intercon-

    nected: Strong OTC products & brands streng-

    then pharmacies and vice versa. Strong pharma-

    cies enable higher self-care and, as such contri-

    bute to efficient public healthcare-system.

    The pharmacists perspective:The biggest and the most complexmerger in self-care

    Jan SMITS, President of the European indepen-dent pharmacists association, PGEU,

    emphasised

    that getting stakeholders including healthcareprofessionals, regulators and consumers in

    every country to come on board was like perfor-

    ming the biggest and most complex merger

    imaginable. Stakeholders are fragmented and we

    must not underestimate the differences in cul-

    tures across the European Union (EU), and It is

    difficult to get everyone in line. Recalling that 46

    million European citizens visit pharmacies every

    day, he said that it was 46 million unique oppor-

    tunities to improve their health and well-being.

    Pharmacists are trusted medication expert en-joying a key touch point throughout continuum

    of care. They also are the last health care profes-

    sional seen by patient before medications are

    taken. Noting that pharmaceutical care is much

    cheaper than secondary/tertiary care (hospital

    costs) and primary care (GP/medical-professional

    related costs), Smits underlined the critical role of

    community pharmacists to provide hygiene ad-

    vice (general and personal), nutrition advice and

    counselling (type and quality of food eaten, etc.),

    lifestyle advice and counselling (sporting activi-

    ties, leisure, etc.), self-medication support in trea-

    ting minor ailments, and support for patients with

    chronic conditions to care of themselves.

    Michael Becker

    Jan Smits

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    Bringing pharmacy knowledgeand students together

    Katarzyna SWIDEREK, President of the EuropeanPharmaceutical Students Association (EPSA)

    presented the approach of pharmacy students

    towards self-care. A study conducted in 32 coun-

    tries showed that Pharmaceutical care, defined

    as the pharmacists contribution to the care of

    individuals in order to optimise medicines use and

    improve health outcomes, is covered by the

    university degree in all countries either as a sepa-

    rated subject or in the overall program.

    Looking at the example of Austria, practice-

    oriented seminars are organised for students

    involving analysis of patient cases. In Belgium,

    series of classes are devoted to self-care with

    practical exercises in virtual pharmacy (with volun-

    teers playing the role of patients), recorded ses-

    sions (feedback can be provided in small groupsof students). In the UK, OTCs are tackled in dis-

    pending classes in every year study including role

    plays with lecturers as patients. It allows to test

    students on their communication skills,

    knowledge of interaction between OTC products

    and prescription medicines.

    Overall, Swiderek concluded that there was a

    positive change in pharmaceutical studies offering

    opportunities to future pharmacists to play a

    more complementary role in primary healthcareand a more active advisory role to the patient in

    the pharmacy, notably in selecting the appro-

    priate non-prescription medicine for their pa-

    tients. Last, she informed the audience about the

    EPSA Training Project aiming at raising awareness

    among students through webinars and fostering

    the development of their soft-skills.

    Following the same approach and promoting abetter interprofessional collaboration and educa-

    tion (with dentistry, psychology and medicine

    students), Swiderek informed the audience that

    EPSA collaborated with the other European health

    care students associations.

    OTC medicinal products, publichealth and pharmacies

    Dagres GIANNIS, Pharmacist, Vice-President ofPanhellenic & Attica Pharmaceutical Association

    (PFS & FSA NPDD) highlighted that a proper

    access to OTC Medicine required an independent

    pharmacist, at least, to interfere first. So far, 100%

    of OTCs are dispensed exclusively in Community

    Pharmacies. While misuse of OTC medicines can

    be of safety concern, Greece guarantees so far a

    high level of safety by restricting the use of most

    medicines to pharmacies. Average Hellenic Phar-

    macies retail profit margin is below European

    average. Advocating for the sale of OTC medi-cines in pharmacies, Giannis listed the main ad-

    vantages of these products among which accessi-

    bility in purchase, safety in use, efficiency in use

    (giving an advantage compared to other easy-to-

    access everyday health treatments), beneficial and

    trustworthy cooperation (Higher Profit Margins

    and Lower Risks in Deals) and prestige.

    Katarzyna Swiderek

    Conference report

    11Giannis Dagres

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    Digital strategies toprovide support to theEuropean citizens

    Session chair Sophia FILAKTOU, Business & In-dustry Solutions at SAP, expressed her pleasure to

    chair this session in her home country and intro-

    duced the speakers who would give insights intothe changes of consumer behaviour e.g. through

    social media. What are the concrete implications

    for the manufacturers of self-care products? How

    to best develop a digital strategy which corres-

    ponds to market expectations?

    An insight into RBs digitalstrategic thinking

    Laurent FARACCI, Senior Vice President, GlobalMarketing and Digital Excellence, RB, underlined

    that the digital transformation of the firm's mar-

    keting involved no longer just talking to consu-

    mers but engaging with them; the questions

    being where, how and when to engage.

    This has led the company growth by 14% lastyear. With the character of Mr Mucus who perso-

    nifies since 2002 RBs Mucinex decongestant the

    number one OTC brand in the US Faracci de-

    monstrated how RB had gone from speaking to

    people to engaging with people in 2016. The cha-

    racter was digitally transformed over the years

    from a simple picture of broadcasting, conversa-

    tions and pharmacy into a complex model that

    leveraged what digital brings to you. Mr. Mucus

    personalises the sickness and can engage with the

    consumers. Mucinex 2.0 moved from advertising

    to a cultural formula. While not digital at first it

    set progressively the scene to start being digital.

    Progressively Mr Mucus has been active on Face-

    book and Twitter, as well as interactive out-of-

    home, to get as close to sick as possible

    using

    detailed data, on illness prevalence and distribu-

    tion for example. According to Faracci, digital me-

    dia allow to bring brand purpose to life. Consu-

    mers must remain be at the heart of everything

    and communications should be channel delibe-

    rate. Last, Faracci advised the audience to

    embrace creativity as a multiplier.

    Sophia Filaktou

    Laurent Faracci

    Legislation, passed in May 2016, is expected to allow the sale of 216 out of 1582 non-prescription medi-

    cines outside Community Pharmacies.The average price of an OTC product being the lowest in Europe,

    there is room for higher prices, still keeping in mind the sensitive economic and social situation of the

    country. Although in theory competition in pricing should benefit the consumers, it may also give the

    opposite results, leading to more expensive products and bigger risks for public health. He concluded by

    warning the industry that if the situation gets worse, state-fixed prices and sales restrictions could easily

    be re-established.

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    Digital strategies from Spanishpharmacists to provide supportto the citizens

    Inma RIU TORRENS, Pharmacist and Director ofSaludability, showed how individual pharmacists

    in Spain were educating consumers online and

    the key factors of their success. She presented

    five examples of ways individual Spanish pharma-cists had gone online to reach Spanish-speaking

    consumers and develop huge communities of

    followers. She noted that 80% of Spanish internet

    users searched for online health information but

    that the overall levels of general health literacy

    was much lower. In response to most frequently

    asked question relating to urine infections or the

    difference between paracetamol and ibuprofen

    and to fight against Dr Google, the blog

    www.boticariagarcia.com has won awards for

    best blog. Its founder has since become a publis-

    hed author, magazine contributor and television

    personality. Focusing first on questions asked by

    consumers mainly around babies needs and

    breastfeeding issues, the website

    www.pharma20.es delivering video messages to

    consumers following purchase in the pharmacy

    on how to use medication was another example

    presented by Torrens. By contrast, the

    www.medicadoo.es site uses infographics to

    make the difference and answer typical posology

    related questions such as: How much ibuprofen

    shall I give to my children? The last example of

    pharmacists community was the Twitter account

    @susitravel used as a platform for weekly conver-

    sation between pharmacists aiming at improving

    advice to patients and increasing product sales.

    Torrens concluded that pharmacist could offer

    health and independent trustable advice online

    and created a community around their brand.

    Social media can be used to boost the communi-

    ty vitality.

    How to best develop a digitalstrategy, which correspondto market expectations?

    Laurent CORAZZA, founder of DIGILITYX, explai-ned that speed is key for a successful digital

    business strategy. The development of the e-

    health market shows that health care is becoming

    digital. Instead of talking about a digital strategy,

    Corazza preferred to talk about a digital roadmap

    to achieve a sustainable and competitive advan-

    tage with digital capabilities. Sharing his own

    experience, he listed four main factors that the

    health industry should take into account to deve-

    lop a digital strategy:

    digital health path: understand how patients

    and all the healthcare actors will interact

    tomorrow in a digital word

    Explore data: data being tomorrows petro-

    leum, collecting and processing data is es-

    sential to understand the needs of the actors

    and to integrate the new technological capa-

    bilities

    Think deep digital: Make sure that your inter-

    nal processes are aligned with your digital

    objectives (full dematerialisation).

    Collaborate: both internally (to make workingtogether R&D and marketing) and externally

    (with start-ups, software companies, digital

    experts)

    In other words, Corazza advised the audience to

    switch from molecule to service (from products

    to services), to use digital services to enforce

    molecule power and justify a better price. Swit-

    ching from cure to care allows to focus on

    disease prevention through patient monitoring,

    and from sell to rent to engage in a long termrelationship rather than a one shot sale.

    Inma Riu Torrens

    Conference report

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    According to Corazza, this approach allows to

    commit on results, and accept to be paid only if the

    patient is cured while making profits with the mo-

    nitoring services. To succeed, the strategy must be

    consumer centric (what will be your role in the

    healthcare value chain?), open-minded (explore

    your eco-system to create innovative services) anddigital ready (encourage initiative and collabora-

    tion between business and IT teams, make sure to

    learn something from your external providers)

    taking into account the digital maturity of the

    company. Reminding the audience that speed is

    key, Corazza concluded that a good strategy requi-

    red adaptation in real time of the roadmap, to

    competitor, to new technologies and to new uses.

    Echoing Corazza, Faracci said that the industry

    must be humble and must be aware of its weak-nesses and strengths to better adapt to the envi-

    ronment in order to put itself in the driving seat as

    new digital platforms emerge. We have strengths

    as an industry in product development and regula-

    tory affairs, but companies like Google are building

    platforms and investing at a level that is orders of

    magnitude greater than we can. As an industry,

    we must steer developments and be seen as a

    force for good as digital channels develop in fu-

    ture.

    Laurent Corazza

    As brands are a major asset of theself-care industry what needs tobe done to strengthen their role?

    Briain DE BUITLEIR, CEO of PGT Healthcare, pre-sented the joint-venture combining the two com-

    panies Procter&Gamble and Teva to allow a better

    growth by synergy of the two parent companies

    and of the culture dedicated to brands. To be suc-

    cessful, brands must put consumer at the centre.

    To create a brand, there must be a belief that have

    an important social purpose (referring to ratio-

    pharm and Swisse), a distinctive proposition, a

    product that delivers (repeat rate number on the

    market like Swisse) and capabilities to make it real(investments and commitments).

    Briain de Buitleir

    Branding self-care

    Roger SCARLETT-SMITH, AESGP President, introduced the session recalling brands are the major asset ofthe self-care industry; 80% of consumers choose their OTC products based on their brand name in Europe.

    He reiterated industry support for umbrella branding, noting that it was clear that consumers were used to

    interpreting and reading the label" and using brands as navigation. In line with its self-care Agenda 2020,

    AESGP will continue to work with regulators to support umbrella branding, Introducing the speakers, Scar-

    lett-Smith asked them how brand communication can evolve in the age of new technologies.

    14

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    PGTs vitamins and supplements brand Swisse was

    built around the belief that you celebrate life eve-

    ry day and this had driven everything the com-

    pany had done with the brand, he pointed out, and

    despite a premium price, it had been incredibly

    successful.

    Then for building a brand, trial and awareness are

    needed and must be repeated; the brand must be

    mentally and physically available to the consumers.

    Showing a chart of the Vicks brand development

    since 1918, de Buitleir highlighted that the fastest

    growing product in PGT portfolio was the un-

    changed original products. Alluding to fashion

    brands like Louis Vuitton or Hermes which do not

    use broadcasting or social media but still continues

    expanding, he provocatively concluded that there

    was no need for more consolidation or new brand

    to grow. While the regulatory environment could

    make things easier it does not prevent the industry

    to build great brands. De Buitleir concluded that

    the obligation of this industry was to serve the

    consumer to the very best of its availability but to

    play that role, the brand had to have a belief.

    An insight into Bionoricasbranding strategy

    Michael POPP, Owner of Bionorica, put forwardthe different approach of his company created in

    1933. The company does not invest in advertising

    so much but this year 17% of the total turnover

    was invested in research to create phytopharma-

    ceutical products that were backed by clinical

    research that had been peer-reviewed. As a result

    the company is the worlds leader in the evidence -

    based proof of efficacy of herbal medicines. In or-

    der to guarantee the quality, safety and efficacy ofits extracts, Bionorica has its own cultivation, per-

    colation-methods, patented extract concentration

    and patented extract drying process. The company

    established the concept of phytosimilar which is

    more than biosimilar because the raw material and

    the process define the phytopharmaceutical and

    therefore are not suitable for generics. Presenting

    the example of Sinupret extract, Popp highlighted

    the challenges in marketing herbal medicines in

    the EU resulting from the divergence in national

    procedures and approaches for these products.Nonetheless academic, alternative, top quality and

    evidence based medicines bring results; Bionoricas

    products are the top products on the German, Rus-

    sian and Ukrainian phytomarket. In these countries,

    the market is driven by physician prescriptions,

    then pharmacists and, when the products are well

    known, the products enter the self-medicationmarket. Doctors are Bionoricas authentic brand

    ambassador since they use the products for

    themselves and recommend them in their private

    environment. Same situations with pharmacists,

    99% of the German pharmacists use Sinupret and

    that is how Bionorica builds trust. Physicians and

    healthcare practitioners are more able to explain to

    patients the differences between plant-based me-

    dicines and other natural products according to

    Popp. In order to enable pharmacists to properly

    counsel consumers and patients on herbal medi-

    cines, Bionorica developed Phytotek, a competence

    center for phytomedicines. In conclusion, Popp

    called EU regulators and national authorities to

    implement the Traditional Herbal Medicines le-

    gislation in a consistent manner, to grant 10 year

    protection for preclinical/clinical data and to intro-

    duce the term phytosimilar. With regard to food

    supplements, Popp asked the EU regulators why

    approved Herbal Medicinal Products are still un-

    dermined by botanical food supplements with

    unauthorised health claims on the market although

    the European Food Safety Authority has rejected

    most of the submitted health claims for botanicals.

    Michael Popp

    Conference report

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    16

    Strengthening the Role of BrandsSome Lessons from Cosmetics

    John CHAVE, Director General of Cosmetics Eu-rope, started his presentation by presenting key

    features of the cosmetic market which is stronglydriven by EU regulation (since 1976). Highligh-

    ting that the absence of risk assessment agency

    was problematic as well as the ban on animal

    testing, he indicated that the rates of innovation/

    reformulation were very high (on average 25% of

    product portfolio annually). Regarding claims

    and advertising in the cosmetics sector, Chave

    explained that they are underpinned by Commis-

    sion Guidance and a soon to come Commission

    report on the effectiveness of the system was

    awaited. The industry strongly rejects positivelist approaches to claims

    and favours the current

    system which gives reasonable flexibility. Turning

    to branding, Chave indicated that there was very

    high brand equity, in general. Diverse brand stra-

    tegies, with some companies focused on distinct

    brand development/acquisition (e.g. LOreal)

    others with single or limited brand approach

    (Chanel). Luxury market sees brand extension

    into fashion and other sectors. Both brand exten-

    sion and maintenance of brand value are sup-

    ported by flexibility given by in market control,

    and absence of strongly restrictive claims envi-

    ronment (i.e. claims supported innovation is key).

    While the cosmetic industry as a whole is concer-

    ned by difficult innovation environment in the

    EU, brand strength is bolstered by relatively high

    emotional engagement with cosmetics and per-

    sonal care brands, particularly in some categories

    (although there is some evidence that this is de-

    clining in importance). Overall, the cosmetic sec-

    tor is traditionally very strong in point of sale/retail environment/consumer experience factors.

    Chave concluded that the cosmetic industry fully

    embraced the digital revolution and was even

    promoted in some cases - by industry, in

    others by social media phenomena such as

    cosmetics blogging.

    John Chave

    What is needed forinnovation in self-care

    Chair Hubertus CRANZ, Director General atAESGP, introduced the session by highlighting

    the strong influence of the legislative and regu-

    latory framework on the future of self-care in

    the areas of self-care medical devices, food

    supplements and non-prescription medicines.

    Before turning to the panellists, Cranz informed

    the audience on the status of AESGP data bases

    on non-prescription medicines and substance-

    based medical devices recently updated as well

    as the one on food supplements, the update of

    which is to be completed by the end of June2016.Hubertus Cranz

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    Conference report

    17

    Regarding the OTC ingredients directory, the

    2016 version comparing the classification status

    (prescription or non-prescription) of a number of

    active pharmaceutical ingredients in 39 countries

    is now available and a printed copy has been dis-

    tributed to the conference participants. Besides

    the publication of the AESGP self-care Agenda2020, Cranz reminded the audience of the two

    topic specific AESGP conferences which took

    place in the past year on substance based medi-

    cal devices (in October 2015) and on the propor-

    tionality of medicines regulation (in February

    2016).

    Status update on the MedicalDevices Regulation

    Lars RITTER, Adviser to Gesine Meiner, rappor-teur on the proposed legislation for the Liberal

    Group in the European Parliament, shared some

    fresh news on the status of the negotiations and

    said final agreement had been reached on the

    long-awaited legislation on 25 May at the 10th

    Trialogue between the Parliament, Council and

    Commission. This came almost four years after

    the publication of the proposed regulations by

    the European Commission in September 2012.

    Noting the AESGP priorities on the negotiatedtext, Ritter indicated that the classification rule 21

    now foresees a classification in the highest ca-

    tegory of substance-based medical devices, or

    their products of metabolism, which are systemi-

    cally absorbed by the human body in order to

    achieve the intended purpose, or which are syste-

    mically absorbed by the human body and

    achieved their intended purpose in the stomach

    or lower gastrointestinal tract. Ritter commented

    that a risk-based approach had been applied to

    ensure that medical devices would only be inClass III if they achieved their intended purpose in

    the stomach or lower intestinal tract. And if they

    were applied in the nasal or oral cavity, and

    achieved their intended purpose in those cavities,

    they would be in the lower-risk Class IIa. Similarly,

    nanomaterials would only be placed in Class III if

    there was a high or medium risk of exposure. If

    the potential risk was negligible, they would be

    put in Class IIa. Assuming the legislation was

    enacted in January 2017, it would come into force

    three years later in January 2020. In what-is-expected-to-be-the-final text, it is proposed that

    certificates issued, after the entry into force of the

    regulation, will remain valid until the end of the

    period indicated on the certificate, which shall not

    exceed five years from its delivery. While no more

    negotiation is foreseen, Ritter noted that the next

    steps were votes in the Parliaments Environment

    Committee on 15 June and Council on 17 June. A

    plenary vote in Parliament will follow in Decem-

    ber.

    Lars Ritter

    AESGP Ingredients Directory

    The AESGP OTC Ingredients Directory com-

    pares the classification status (prescription or

    non-prescription) of key active pharmaceuti-cal ingredients used in self-care in 39 coun-

    tries (25 European and 14 non-European).

    It is based on information provided by WSMI

    and AESGP member associations and is

    widely recognised as the most comprehen-

    sive analysis in this context.

    http://www.aesgp.eu/media/cms_page_media/68/AESGP%202016%20Ingredients%20Directory_FINAL.PDFhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%202016%20Ingredients%20Directory_FINAL.PDFhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%202016%20Ingredients%20Directory_FINAL.PDFhttp://www.aesgp.eu/media/cms_page_media/68/AESGP%202016%20Ingredients%20Directory_FINAL.PDF
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    Jurate Svarcaite

    Jurate SVARCAITE, Secretary General of the Phar-maceutical Group of the European Union (PGEU)

    congratulated Ritter for the important legislative

    work done on the very challenging and broad ca-

    tegory of products covered by the definition of me-

    dical devices.

    Noting that medical devices had been one of the

    most innovative sectors in self-care, she pointed out

    that pharmacists were still building trust in these

    products as they were still more comfortable with

    the regulatory framework applicable to medicinal

    products. As healthcare professionals, Svarcaite said

    that pharmacists were highly interested in the medi-

    cal devices requirements regarding pharmacovigi-

    lance or any regulated activities allowing detection,

    assessment, understanding and prevention of medi-

    cal devices related issues.

    Food Supplements - regulatorydevelopments on botanicals inthe EU

    Alexandra NIKOLAKOPOULOU, Head of Unit atthe European Commissions Directorate General

    Health and food safety, explained the regulatory

    framework applicable to food supplements and the

    state of play of the ongoing so-called REFIT exer-cise in relation to the Nutrition and Health Claim

    Regulation.

    This evaluation will besides nutrient profiles -

    examine whether the current rules concerning

    health claims on plants and their preparations used

    in foods are adequate, and how the use of such

    claims interacts with the current applicable food

    regulatory framework on plants and their prepara-

    tions. She reminded the audience that more than

    500 claims on plants and their preparations recei-

    ved an unfavourable assessment from EFSA in the

    context of their scientific assessments, and this

    raised concerns. To date, the remaining over 1500

    submissions concerning such health claims havenot yet undergone the scientific evaluation by

    EFSA.

    The Regulation provides for the substantiation of

    health claims made on plants and their prepara-

    tions used in foods by demonstrating the causal

    link between consumption of such foods and the

    claimed beneficial effect. This precludes any safety

    considerations by EFSA on the use of the substance

    in foods when assessing the claim. She explained

    that this had given rise to increased concernsamongst the Member States on the authorisation

    of health claims on certain substances when no

    regard is given to the safety aspects of their use in

    foods. In addition, an Overview Report which was

    finalised in 2015 based on a series of fact finding

    missions carried out by the Food and Veterinary

    Office (FVO) in Member States in 2013 and 2014 in

    order to gather information regarding the controls

    on food supplements highlighted the problems

    that Member States face due to differing national

    rules for the use of plants and their preparations infoods.

    Alexandra Nikolakopoulou

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    Nikolakopoulou warned that the REFIT process

    would be lengthy because of the Commissions

    new commitment to employ wide consultation,

    following its adoption of its Better Regulation

    Communication of 19 May 2015. An action plan

    would not be presented before the first quarter of2018, she said, after the final report had been

    completed in the fourth quarter of 2017. The re-

    sults of this evaluation will be used to decide on

    the next steps regarding this policy area. Nikola-

    kopoulou indicated that an external contractor

    would be performing a study during 2016-2017 to

    feed into the final report and that there would be

    a 12-week open public consultation as well as an

    eight-week stakeholders consultation targeted at

    small-and medium-sized enterprises (SMEs) by the

    end of 2016.

    Svarcaite raised concerns about certain food

    supplements which can be of different quality le-

    vels and can make claims that are not even pos-

    sible medicinal products. Pharmacists are worried

    that the food supplements market will destroy the

    herbal medicines market.

    Echoing her comment in relation to the medical

    devices legislation, she underlined the absence of

    any vigilance system allowing detection and pre-

    vention of food safety related issues. Pharmacists

    are highly sensitive to the safety of food supple-

    ments and the absence of vigilance system to mo-

    nitor safety issues does not help to build trust in

    these products. In addition, she noted that the

    level of information required on food being less

    exhaustive than on medicines does not allow a

    proper information of the consumers with regard

    to possible interactions with medicines.

    Innovation in self-care inEurope - Update from a MedicinesRegulatory Agency

    June RAINE, Chair of the European MedicinesAgency (EMA)s Pharmacovigilance Risk As-

    sessment Committee (PRAC) and Director of Vigi-

    lance and Risk Management of Medicines at the

    Medicines Healthcare products Regulatory Agency

    (MHRA) of the United Kingdom, started her pre-

    sentation by referring to the definition by default

    of the non-prescription legal status; the naturallegal status is pharmacy unless active decision ta-

    ken to confer Rx status. It is a simple principle but

    it is very important to remember it. Being at an

    important time juncture, she added that it is im-

    portant to reflect on fundamental questions:

    where we come from first, who is setting the pace

    and how can we influence the future of self-care.The Tajani report on corporate responsibilities in

    promoting good governance on non-prescription

    medicines was the output of a successful stake-

    holders initiative at EU level and marked a signifi-

    cant landmark. Amongst others, it acknowledged

    that availability was an issue with only 5 actives

    being available in all Member States.

    Five years later, one could have expected that new

    switches would have deluged Europe, but realisti-

    cally its rather a slow trickle Importance of

    stakeholder engagement in reclassification pro-

    cess was identified by the EU Working Group on

    Promoting Good Governance of Non-prescription

    Medicines as a key factor to successful switch:

    stakeholder platforms should be established na-

    tionally to share views & develop strategies for

    common approach to supporting patient access to

    non-prescription medicines and stakeholders

    should be involved early in reclassification process

    so concerns addressed and training prepared. At

    national level, the UK government has always

    been committed to increase access to medicines

    as soon as it is safe to do so.

    June Raine

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    George Dokios

    Recently a UK stakeholders platform on reclassifi-

    cation to non-prescription medicines was launched

    and the interim report was published in February

    2016. Part of this initiative a dedicated webpage

    and an assessor guide on evaluation of a switch

    application will be launched. In 2015, esomepra-

    zole was the first proton pump inhibitor on theGeneral Sales List (GSL). Heart burn can be an im-

    pedance on everyday life and easier access makes

    a real difference.

    Who should be setting the pace? She mentioned

    the PRAC which current focus is on simplifying the

    pharmacovigilance legislation and the EU strategy

    2020 arising from the alignment of the Heads of

    Medicines Agencies (HMA) and the EMA around 4

    main pillars. Availability of medicines is one of

    them, including availability of well-established me-dicines and non-prescription medicines. The

    CMDh has a very consistent strategy with the EU

    strategy 2020 and its Multi Annual Work Pro-

    gramme: easier access to non-Rx, explore decen-

    tralised (DCP) and mutual recognition procedures

    for OTCs and particularly in procedures where

    legal status is different between Member States.

    The first step is to update the Best Practice Guide

    on DCPs for non-prescription medicines.

    Key to success of the self-care sector are innova-tion, simplification, flexibility and stakeholder col-

    laboration. In 2014, ulipristal an emergency contra-

    ceptive was switched centrally. She gave tribute to

    companies that put a lot of efforts and resources

    into switches which set the success (although

    maybe not always the case from a commercial

    point of view). Maintaining success involves

    keeping the product information up to date and

    constantly improving the benefit- risk of a product.

    Success needs to be monitored too and for

    example the easy access to emergency contracep-

    tion has played a role in the decrease in the num-ber of pregnancies in teenage girls. It is also crucial

    to seek opportunities to simplify and it is what the

    MHRA is doing when looking at its switch process

    with fresh eyes. Flexibility in interpretation is also

    important; the recent switch of sildenafil in Poland

    is substantially different from the product with the

    same substance authorised through the centra-

    lised procedure. Lastly, collaboration between

    committees, external cooperation with pharma-

    cists, doctors and patients is key. Hearing the voice

    of patients and what risks they are ready to accept,what risk management plans mean for stake-

    holders is one of the direct goal of the EMA public

    hearings.

    Thanking Raine for her speech, the Chair

    highlighted the importance of stakeholders

    cooperation to promote innovation in self-care.

    Scarvaite said that, within the Committee for Me-

    dicinal Products for Human Use (CHMP) at the

    EMA, there was some mistrust and criticism to-

    wards pharmacists that prevented a pragmaticapproach towards the classification of medicinal

    products. She called for a better integration and

    consideration of the healthcare professionals re-

    presentative notably pharmacists within these re-

    gulatory platforms.

    Challenges for tomorrow

    Self-Care in Greece

    The session Chair George DOKIOS, Director Ge-neral of the Greek industry association, EFEX,

    described in detail the difficulties that the Greek

    healthcare system had been facing in the past

    years due to the economic crisis. Showing fi-

    gures about the unpreceded decrease of the

    total pharmaceutical market (by 60% between

    2009 and 2015), he highlighted that this trend

    was in contrast with the development of the OTC

    market for the same period (increase by 31%between 2010 and 2015).

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    According to Dokios, the good situation of the

    OTC market is multifactorial but results from two

    key milestones: the 2010 decision to de-

    reimburse OTC Medicines and the 2014 decision

    to lift price barriers (applicable as of January

    2017). EFEX works in further promoting the OTCmarket as part of health-care notably because of

    its economic benefits for the healthcare expendi-

    ture: savings up to 160mm in pharmaceutical

    expenditure, productive allocation of doctors

    time, less patient visits at health centers and less

    working hours lost due to doctors visits. To sup-

    port the development of self-care, Dokios called

    for a simplified and more predictable OTC regis-

    tration process coupled with better self-care in-

    formation for consumers and educational pro-

    gram for pharmacists. The industry will commit indeveloping healthy competitiveness. Dokios con-

    cluded that if all Social Partners engaged actively

    in promoting the effectiveness of self-care and

    the role of the pharmacist was upgraded to that

    of the Primary Care Consultant, self-care would

    be fully established in Greece.

    Challenges for tomorrow: theGreek economy and the health

    care sector

    Nikos VETTAS, Professor of Economics and Ma-naging Director of the Foundation for Economic

    and Industrial Research (IOBE) presented the ove-

    rall economic situation in Greece. Since 2010,

    Greece is in an adjustment program meaning it

    cannot control its monetary and fiscal policy.

    How can you change the country and increase

    the competitiveness with no means outside hu-

    mans will? Noting that the Eurozone crisis

    stopped the growth for all Europeans and pushed

    all investors out of Greece, he listed the two typesof measures comprised in an adjustment pro-

    gram: structural reforms requiring to become

    better and austerity. In accordance with this pro-

    gram, between 2009 and 2014, Greece traded its

    public deficit for a huge recession and made the

    economic much smaller. According to Vettas, the

    economy could be growing again after the sum-

    mer 2016. However, due to a lack of competi-

    tiveness and competition in the economy, it can-

    not go back on its feet unless it doubles the in-

    vestment rate. Public finances have been fixedbut since the economy has been shrinking a lot

    of new troubles are emerging such as pensions

    which become a larger percentage of the GDP

    and requires an additional cut in the expenses.

    Turning to healthcare, he indicated that it was the

    spending category that had been shrinking the

    most in GDP. Noting a negative trend in every-

    thing, Vettas highlighted that the public health

    expenditure growth showed an unpreceded

    shrink. As a result, during the economic crisis pe-

    riod there was a shift of household expenditure

    towards pharmaceuticals and hospital care.

    Looking at the OTC market, Vettas noted that

    OTC share in Greece was among the lowest com-

    pared with the rest of Europe. However, the res-

    pective market shares depend crucially on the

    range of non-prescription medicines included in

    each country. Among the various OTC categories,

    vitamins and minerals had the greatest share of

    the market, followed by analgesics and cold re-

    medies.

    According to Vettas the Greek economy is a labo-

    ratory that could happen elsewhere since Euro-

    zone economies are gradually evolving in scena-

    rios where public spendings have to be discipli-

    ned. Warning about the growing pressure on pu-

    blic finances, he urged the audience to redefine

    how we guarantee the economic and social wel-

    fare of citizens (social security, education,

    healthcare etc). To succeed, Vettas strongly be-

    lieves that we need to boost innovation.

    Nikos Vettas

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    Laurent Alexandre

    The death of self-care

    Laurent ALEXANDRE, President of NBIC Finance and a familiar of TED shows, closed the conference by aprovocative and thought-provoking talk: the self-care sector will die!

    The traditional self-care and healthcare in general

    are at the heart of an important mutation. The new

    technologies in the hands of the GAFA (Google,Apple, Facebook, Amazone), neuro-cognitive

    sciences, nanotechnologies, IT and biotechnology

    will radically transform the future of healthcare and

    self-care. He warned participants that the e-health

    will become a reality in no time: genes will become

    editable within 10 to 20 years and the genome will

    be sequenced by 2030 with as consequence possi-

    bility to enhance humans, solve many diseases,

    stop or radically delay the aging processes. Lead

    thinkers in the GAFA predict that artificial intelli-

    gence will become more powerful than humanintelligence, and that human brains will be con-

    nected to robots which have the size of nano

    (nanobots).

    It will be a complex and at least for some frigh-

    tening world and new issues such as data privacy,

    technophobia, and regulatory issues will rise. He

    urged the assistance not to ignore the mutation

    but rather to get prepared for it.

    Vienna

    30 May - 1 June 2017

    53rd AESGP

    Annual Meeting

    Alfred Grn & Gerhard Ltsch

    Invitation to Vienna 2017

    At the end of the conference Gerhard LTSCH and Alfred GRN, from the Austrian Self-CareAssociation (IGEPHA) invited all participants as well as all those interested in the latest developments on

    self-care around the world to the 53rd AESGP Annual Meeting, which will take place in Vienna from

    30 May 1 June 2017.