This year marks the 20th anniversary of the European Pharmacists Forum, an event we will be celebrating later this year. I was the instigator of the EPF and I have followed its development very closely all these years. It still has my wholehearted support and it remains a critical forum for the discussion of pharmacy and how it can evolve for the future.

Looking back, we can see that pharmacy has made great progress in these past two decades. We have retained our place at the heart of our communities, building ever greater relationships with our patients while maintaining the safe and efficient supply of medicines.

There are many challenges facing European pharmacists at present. Our customers are also changing. They have become used to having digital technology in their hands and are becoming more informed and more demanding. As pharmacists we must invest in our own digitalisation so we can deal with this.

We can see good signs of what the future can offer. Many of us in the profession have taken on new roles that were almost unimaginable in 1999 – such as becoming prescribers in the UK, administering vaccines in France and Portugal, using genetic tests to alter patients’ medication

and installing automated dispensing systems in the Netherlands, as well as establishing websites and delivering new services from our own pharmacies. There is much to be proud of.

Our role in improving the health of the public through support for prevention and self-care – two key themes from our 2015 White Paper – is becoming widely recognised. We are now seeing innovative schemes like mole screening and sore throat test-and-treat being adopted by health systems. These are no longer just talking points, they are real examples that others can and should copy.

We have shown time and again that we can innovate and become more efficient to meet changing needs. Now we need to show that we can embrace digital technology.

It is the changes that will come from the increasing use of data in healthcare that are most important to understand. This demands a new view of the world, new partnerships and especially new ways

of working with our customers. People are becoming more engaged with their own health as they gain the technology to monitor it closely. They are being empowered by it. We must also let it empower us. The EPF has been at the forefront of exploring how we can benefit from these changes.

A challenging future awaits us, especially in a digital world. It will not replace the need for a physical presence for advising patients, and delivering products and services, but it will change the way in which we do that. It will allow us to get closer to patients and understand their needs, using our expert and professional advice to support them. Data and technology will help us to make their healthcare personalised, delivering the outcomes that matter to them.

This closeness will be rich in opportunities for us to be at the centre of the world of health. If we get this right we will be transformed. There are bright lights ahead and we must go forward towards them.

European Pharmacists Forum Newsletter – English edition March 2019 Issue 53

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Pharmacies continue to operate in uncertain times, but Ornella Barra, Co-Chief Operating Officer, Walgreens Boots Alliance, says that by embracing change and digitalisation we can find our way forward in 2019…

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AROUND EUROPE

02

EPF March 2019

United Kingdom

France

Czech Republic

NHS plan seeks more clinical pharmacists

The NHS in England will seek to recruit “substantially more” clinical pharmacists to work closely with local doctors as part of a new 10-year plan. However, there are concerns that this will be at the expense of community pharmacies with plans for “further efficiencies through reform of reimbursement and wider supply arrangements” for the sector.

The NHS Long Term Plan sets out how an additional £20.5bn will be invested over the next five years. Of this, £4.5bn is promised to build up multidisciplinary teams working with local primary care networks covering populations of 30-50,000 people. These teams will include clinical pharmacists undertaking medication reviews in conditions such as respiratory disease.

There is a focus on prevention with action promised in tackling smoking, obesity and alcohol misuse and on reducing health inequalities. These could bring opportunities for community pharmacies to deliver more services to support their local populations.

Following the launch of the Plan, NHS officials have suggested that proposals to extend automation in pharmacies may be revived. These could see an expansion of so-called “hub-and-spoke” operations, whereby prescriptions are assembled at large automated hubs before being returned to local pharmacies (“spokes”) to be collected by patients. The UK government consulted in 2016 on plans to allow independent pharmacies to be part of such arrangements but has yet to bring in the necessary changes to legislation.

(Source: NHS England)

French OTC medicine segment declines 4.6% y/y in 2018 to EUR2.1 bn

The French Federation of the Pharmaceutical Industry for Responsible Self-Medication (Afipa) has published an annual survey of OTC medicine sales in the country during 2018. The survey results reveal a 4.6% year-on-year decline in non-prescription and non-reimbursed sales to EUR2.106 billion. The self-medication market amounted to EUR2.24 billion in 2017, following a 3.7% decline. In 2018, reimbursable non-prescription medicine sales declined 2.0% y/y to EUR437 million, whereas non-reimbursable, non-prescription medicines sales (strictly OTC) fell 5.3% overall to EUR1.669 billion. The second consecutive year of annual decline in pharmacy self-medication sales is attributed to a combination of seasonal variation caused by weather-related events (including a later influenza season) and increased competition from the homeopathy and “natural health products”, according to the survey respondents. The 2017 decision by French regulators to register certain codeine and morphine derivative products as prescription medicines, rather than OTC products, after concerns over addictive practices, also continued to have a negative impact on the performance of the self-medication market in France. The therapeutic areas most affected by the 2018 OTC sales decline were respiratory and analgesic OTC medicine. Dermatology medicine sales increased 0.6% y/y to EUR220 million.

(Source: IHS, Life Sciences, Jan 2019)

Czech Republic: Czech MoH praises successful implementation of e-prescription

The Czech Ministry of Health (MoH) has praised the implementation of electronic prescriptions in the country, which became obligatory for doctors at the beginning of last year. The MoH noted in a recent press release that – according to data from the State Agency for Drug Control (SÚKL), which is responsible for the implementation of the e-prescription system – 58.5 million e-prescriptions were issued during 2018, and 56 million of these were dispensed. Significantly, SÚKL's data shows how the popularity of receiving information about prescriptions in electronic format has grown among Czech patients during the year: from 17,386 text messages sent with prescription data in January, the number increased to 474,000 in November. One of the elements of the e-prescription system that doctors are reported to have found the most useful is the facility to check whether patients have in fact received the medicines they were prescribed. During 2019, the next stage of the e-prescription system is being introduced, including the sharing of medical records between doctors and pharmacists, enabling the identification of potential adverse interactions between different prescribed medications.

(Source: IHS, Life Sciences, Jan 2019)

Netherlands

KNMP reports drug shortages increased 5% y/y in Netherlands during 2018

On 14 January 2019, the Royal Dutch Pharmacists Association (KNMP) reported a 5% year-on-year increase in shortages of medicines in 2018. KNMP published statistics that identified 769 shortages of medicines in 2018; this compares with 732 medicine shortages in 2017, which itself represented a 3% y/y increase from 625 reported shortages that occurred in 2016. The types of drugs that were identified included treatments for serious diseases such as the Parkinson's disease drug Sinemet, medication for thyroid conditions, and epilepsy. Limitations were placed on pharmacies from dispensing contraceptive pills for three months in 2018 due to a lack of available deliveries. The KNMP attributes medicine shortages to low-pricing arrangements that are offered to producers, which reduce the attractiveness of the Netherlands' relatively small pharmaceutical market. Moreover this situation could be exacerbated in view of Brexit.

The pharmacy industry's trade association has stated that the only practical solution is to reform the Pharmaceutical Pricing Act legislation, which has caused price decreases in recent years.

(Source: IHS, Jan 2019)

Spain

Turkey

Ceiling on pharmacy ownership in the same region, accepted

Italy has agreed to a lower 10% ceiling on the ownership of pharmacies by large single company entities in the same region. The 10% cap applies to limited liability companies and co-operatives. In 2017, Italy adopted regulations imposing a cap on pharmacy ownership set at 20% per region. Pharmacies will be granted a 36-month window to adjust to the new ownership restrictions. Following that period, fines can be levied at EUR100,000 per each excessive pharmacy. The lower pharmacy ownership restrictions per region are intended to increase competition and thereby drive down medicine prices between pharmacies. The legislation is likely to reduce the concentration of pharmacy ownership and boost price competition in some areas of the country, although the changes have the opposite effect of reducing pharmacy growth rates and business investment. (Source: IHS, Life Sciences, Jan 2019)

Italy

GermanyPortugal

03EPF March 2019

Romania

Infarmed adopts protocol for dealing with drug unavailability

Medicines regulator Infarmed has issued a statement on medicine access in Portugal in 2018 and recent measures adopted to prevent and address supply disruptions. In January it adopted internal guidelines for better management of instances of supply disruption. In particular, setting out specific responsibilities of actors along the drug commercialisation chain and envisaging a greater level of intervention by marketing authorisation holders, wholesale distributors and retailers and the involvement of pharmaceutical experts in issuing opinions regarding therapeutic alternatives. As a result, the regulator received fewer user notifications of difficulties in drug access in 2018 than in 2017 (435 versus 455). The National Pharmacies' Association indicates a 33% year-on-year increase in the volume of unavailable drugs. They include Parkinson's disease drug Sinemet and diabetes treatment Trajenta. Moreover Infarmed has updated the list of medicines subject to an obligation of prior notification before they can be exported (21 active compounds). Wholesale distributors wishing to export the products from Portugal to the EU must notify the regulator no fewer than five and no more than 20 days in advance.

(Source: IHS, Feb 2018)

ARPIM highlights continued problem of drug withdrawals in Romanian market

The Romanian Association of International Drug Manufacturers (ARPIM) has renewed its warnings on the disappearance of drugs from the Romanian market. During the past four years, ARPIM estimates that 376 innovative medicines have been withdrawn, and another 26 drugs were apparently "notified for discontinuation" in the first two weeks of January. According to ARPIM the "two major causes" of these withdrawals are the pricing policy (establishing Romanian medicines as the lowest-priced in Europe) and the clawback tax with quarterly increases, and that these have "major consequences for patients", particularly when they affect medicines "without any therapeutic alternative". The agency confirmed its support for the government's recent initiative to review the current clawback tax approach, and confirmed that it would endeavour to collaborate closely with the government in establishing a "workable solution."

(Source: IHS, Life Sciences, Feb 2019)

Pharmacists support fixed prices for prescription medicines

The Federal Union of German Associations of Pharmacists (ABDA) rejected on 17 January proposed measures for a ceiling of EUR2.50 on the discounts that online/mail-order EU pharmacies could offer in Germany, reiterating their support for upholding the system of fixed prices for prescription medicines, and declaring themselves ready to discuss the necessary legislative measures in the coming weeks.

The government stated that a ban on online/mail-order sales of prescription drugs would be imposed. In 2016, the European Court of Justice ruled that an online/mail-order pharmacy from another EU member state was able to offer discounts on prescription medicines in Germany. Existing German regulations require prescription medicines to have a fixed price and be priced the same in every pharmacy. Pharmacists may seek a larger financial offer from the government, in return for the extra medicine safety duties that they are taking on this year, and that their ruling out of any compromise on the online/mail-order pharmacy question is part of this 'haggling' process.

(Source: IHS, Life Sciences, Feb 2019)

Support for Andalusian government's plan to scrap controversial drug tenders

Andalusia’s new regional government has received further support from the local pharmacist community for its plans to eliminate the current tendering model for prescription medicines in the region. Manuel Fuentes, president of the Pharmacists Association of Granada, has praised the move, stating the current model prevents users from accessing all medicines equally to the rest of Spain. The Business Confederation of Pharmacies in Andalusia and the Andalusian Association of Pharmacists (Afaran) also expressed their support. Meanwhile, Health Secretary, Jesús Aguirre, stated that his government was committed to eliminating the controversial system; however, this would require changing current Andalusian legislation that obliges authorities to conduct annual tendering exercises for prescription drugs. Aguirre also dismissed suggestions that it led to substantial savings.

(Source: IHS, Life Sciences, Feb 2019)

Action against companies that stockpile medicines ahead of price rises

Health minister Fahrettin Koca has vowed to take punitive action against companies found to be stockpiling medicines ahead of expected price rises later this month. Recently, inspectors have discovered that 42 manufacturers have been stockpiling pharmaceuticals. Under Turkish pharmaceutical pricing laws, the Price Evaluation Commission sets a euro-Turkish Lira exchange rate to be used in the pricing of medicines. The price changes come into effect within the next five days. If the lira has depreciated against the euro in the previous year, the euro rate is set at 70% of its average value. However, the government has amended the pricing decree to set a 15% cap on price increases. Although this was the highest increase to take effect in 14 years, it fell short of what should have been a 23% increase. Reports of stockpiling reflects extremely difficult market conditions for pharmaceutical companies, as well as pharmacists, due to the depreciation in the value of the Turkish Lira. Profits have been squeezed, leading some manufacturers to limit the supplies of some products in the market.

(Source: IHS, Feb 2019)

Dominique Jordan (President, FIP) began the day by sharing detail of a survey undertaken of its member organisations. He discussed how the transformation of the European pharmacy has brought both challenges and opportunity, and that pharmacists need to bring added value, adopt new technologies and offer new services to patients. They will also have to form new partnerships, especially with manufacturers, and share best practice.

Giovanni Monti (VP, Director of Healthcare Innovation, Walgreens Boots Alliance) explained how WBA has embarked on a journey to exploit the potential offered by new technologies, and position the pharmacy as a healthcare hub. This strategy is based on innovative services launched primarily in the US market, such as the Walgreens App, Find Care Now, and the partnership with LabCorp.

Hélène Tixier (VP, Head Global Comops Digital & MCM Strategy, Sanofi Pasteur) shared detail on the arrival of UberHealth and the reaction of Sanofi Pasteur who decided to strengthen their digital offer with Flumania, an App that utilises gamification to increase patient engagement with the flu vaccination and its benefits.

Ornella Barra (Co-Chief Operating Officer, Walgreens Boots Alliance) gave an overview of WBA’s performance up to December 2018, and gave detail about strategic partnerships with Birchbox, Kroger, and LabCorp. Ms Barra also spoke of the 80th anniversary of Alliance

Healthcare, and ensured delegates were aware of the dates and theme of the 2019 Alphega European Convention, as well as the upcoming 20th anniversary of the EPF.

Tricia Kennerley (Vice President, Director of International Public Affairs, WBA) introduced workshops for each of the four workstreams:

Working with stakeholders reported pharmacists were very aware of the need to engage with digitalisation. Pharmacists are more digitally advanced in some countries than others and the digitalisation of pharmacy services has encountered legal barriers around Europe. The need for pharmacists to stay in control of prescriptions was emphasised. The expanding the role of the pharmacist gave updates on e-prescriptions, health cards, healthcare data and e-health initiatives affecting pharmacists and GPs across Europe. Embracing digital evolution followed this by sharing how digitalisation is influencing the work of GPs and pharmacists, as well as affecting patients’ purchasing habits. Emphasis was on the need for pharmacists to co-operate with GPs. The group also discussed e-prescriptions and noted that some countries/regions are more advanced than others in this field. The new models working group concluded by noting The Netherlands is the only country where biometric data can be collected and used by pharmacists, and online Therapeutic Plans can be consulted and modified by

the doctor, pharmacist and patient. It was agreed that online consultations are an opportunity for pharmacists and Amazon’s system was reviewed.

Jay Patel (England) discussed the political issues affecting pharmacy, including financial difficulties such as the reduction in fees, stable margins and reimbursement of overpayments. He also spoke of shortages of generics, doctors and pharmacists and sketched the future of pharmacy as envisaged by the NHS.

Philippe Gaertner (France) gave detail on issues including: the wider availability of medicines through community pharmacies, how the pharmacists’ remuneration system is due to change by 2020, the consequences of the law for financing Social Security in 2019, the experimental flu vaccination programme and discussed services such as e-medicine, patient electronic records and the medicine review.

James McKay (Northern Ireland ) spoke of the challenge posed by a 50% growth in the over 65 population by 2032. He added that in 2019 there will be an assessment of pharmaceutical needs. Finally, he explained services offered by pharmacies in Northern Ireland, their challenges and opportunities.

Florina Bonifate (Romania) described the impact of political instability on healthcare legislation, including pharmacists’ services. The pharmacy market is experiencing shortages of medicines due to very low prices. She also stressed the growing importance of pharmacy chains.

FOCUS

04EPF March 2019

The final European Pharmacists Forum of 2018 took place in Monaco on 10 and 11 December, bringing together leading pharmacists from across Europe to discuss key issues affecting the pharmacy sector.

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Highlights from the final EPF seminar of 2018