AESGP Annual Meeting, Day 1: Life After COVID-19, The Value Of Self-Care And MDR Implementation

Welcome & Introduction

For more than 50 years the Association of the European Self-Care Industry, the AESGP, has come together to debate and discuss the latest regulatory, policy and business developments, but never before has it done so virtually.

Opening the association’s 57th Annual Meeting via video call from Germany, AESGP president Birgit Schuhbauer told delegates that the European consumer healthcare industry had a “brilliant future ahead of us.”

While COVID-19 continued to disrupt consumers’ lives, it had triggered a significant surge in interest in self-care, she said, as European countries asked their citizens to stay at home and look after their own health. “I don’t know how we would have managed the pandemic without self-care,” insisted Schuhbauer, who is also Johnson & Johnson’s vice-president of self-care for EMEA and developed markets.

A significant proportion of Europeans were taking extra precautions to avoid illness transmission, she noted, with many going the extra mile to maintain good health, driving increased sales of vitamins, minerals and supplements in particular.

As life returned to normal the challenge for industry was to encourage people to “continue to think of self-care first for self-manageable issues,” Schuhbauer explained, and to provide them with the tools to do so. Digital was key to this, she noted, as in future more self-care interactions would happen online.

Concluding her presentation, Schuhbauer said she hoped that by the end of the conference delegates would share her optimism about the “brilliant future for self-care.”

Session 1 – Aftermath Of COVID-19: What is Next For The Self-Care Market?

Almost all business leaders believe COVID-19 has changed consumer behavior for good, but consumers themselves are more uncertain, revealed Kantar Consulting Amsterdam’s general manager Mark Visser as he kicked off the first session of the conference.

Looking ahead to life after the pandemic, Visser said that while 90% of business leaders were convinced behaviors adopted during 2020 were here to stay, Kantar’s global research showed only half of consumers agreed. The other 50% believe things will go back to the way they were before the outbreak. 

While consumers' response was mixed, Visser noted over two-thirds of those questioned at the start of 2021 believed a return to “normality” was still at least 12 months away. Painting a picture of what the “new normal” might look like, Visser said the top behaviors consumers planned to retain post-COVID included increased hygiene, healthy eating and online shopping.

On online shopping, Visser noted the adoption of e-commerce was showing every sign of sticking, provided delivery costs did not become prohibitive in a tougher economic environment.

Building on this point, IQVIA Consumer Health’s global VP of consulting services and thought leadership, Amit Shukla, said the growth of e-commerce could not be ignored by self-care companies. For the consumer health industry e-commerce “used to be a hobby,” he claimed, “now it’s a must win channel.”

Increasing e-commerce adoption among consumers was here to stay and to thrive, he insisted. Also important was increased attention during the pandemic on personal well-being, with consumers looking to prevent illness and maintain good health. This move away from just looking to treat minor ailments would have a significant impact on consumer health innovation, Shukla insisted.

Highlighting the impact COVID-19 had already had on the consumer health market, Shukla pointed to slowing growth in 2020 as sales of respiratory products plummeted due to social distancing. As a result, global OTC sales had advanced by 3.8%, down from 4.7% in the prior year. OTC growth was expected to recover in 2021, he insisted, but it would be uneven, with the second-half of the year likely to be stronger than the first.

The importance of good preparation for a more uncertain future was highlighted by Sven Göth, CEO and founder of the Digital Competence Lab.

Göth argued the sudden changes to consumers' daily lives brought on by the pandemic were “just the beginning.” Ongoing disruption to the self-care market was likely to come through technology and the evolving needs of consumers, he observed.

Consumer health companies needed to learn to adapt quicker, he maintained, “as in a rapidly changing world the status quo is not the answer.”

One area where this was vital was digital. Göth said firms needed to be thinking about what they could do with the tools available now to improve their products and services.

While companies needed to be bold when making decisions to prepare for the future, this was not enough on its own, he argued. “A great vision with no execution is no good,” Göth insisted, arguing companies needed to identify the necessary resources to make the change, whether that be their own employees or new strategic partners.

Prioritizing partnerships was central to the session’s final presentation from Anna Nightingale, GSK Consumer Healthcare’s head of R&D for EMEA.

For self-care to thrive in Europe post-COVID it was “absolutely critical” for the industry as a whole to embrace partnerships, Nightingale insisted, as no single player could effectively tackle all of the barriers alone.

“If we want to realize the benefits of self-care we need to work together to establish a partnership ecosystem where public and private sector organizations work together towards the same collective goal,” she argued. “Such an ecosystem would offer people convenient, accessible and comprehensive support from the moment they first seek out information through to finding a solution that’s right for them.”

Building partnerships was just one of five areas of focus necessary to step up self-care adoption across Europe, Nightingale explained, along with health literacy, prevention, policy and pharmacy support. 

Session 2 – The Role Of Self-Care In Resilient Healthcare Systems

The second session was opened by Uwe May – co-founder of management consultancy May und Bauer – who presented the results of an AESGP-commissioned study on the “economic and social value of self-care.”

According to May, over a billion minor ailments are treated by self-medication in Europe every year, saving roughly €35bn in direct and indirect costs. Put another way, the research found that, every Euro spent on OTCs by consumers saves national health systems €4.60 and economies €2.10. All in all, “every case of self-care saves on average €14.14 for the national economy and more than 1.5 hours and €2.18 for the patient,” May explained.

However, this is what May called the “status quo” scenario. May and colleagues in their research found that anywhere up to a quarter of doctors’ consultations for minor ailments could be substituted by self-care solutions, depending on the country.

“In the UK, for example, where self-care already matters a lot to people and a high number of medicines are available OTC, only 10% of GP consultations could be substituted,” May pointed out. In Slovenia, by contrast, 25% of all GP visits could potentially be prevented by self-care solutions. “If the role of self-care can be strengthened, its social and economic value could be significantly increased in the future, potentially saving a further €17.6bn in direct and indirect costs,” May concluded.

AESGP’s study was complemented well by recent research from the Pharmaceutical Group of the European Union (PGEU), presented by the association’s secretary general, Ilaria Passarani.

Passarani began by saying how “very proud” she was of the contribution that European pharmacists made during the pandemic. Community pharmacists played a key role in tackling COVID, the PGEU study found, supporting local communities in accessing treatments and care, providing advice on how to disinfect surfaces and use disposable face masks, as well as relieving pressure on primary care service by preventing unnecessary visits to emergency rooms. In several EU Member States, pharmacists have also been allowed to administer COVID-19 vaccinations.

Drawing lessons from the pandemic, Passarani argued that European pharmacists are both willing and able to expand the scope of their practice to respond to patient and healthcare system needs. “Traditional models of pharmacy are changing,” she concluded. “The future model of pharmacy is likely to include more complex forms of intervention to respond to evolving patient needs.”

Self-care advice alongside integrated digital technologies offer new ways of moving “from hospital-centered care to patient-centered care treating patients as close to their home as possible,” she insisted. However, pharmacists must also be “adequately remunerated” for these additional services they are ready to provide, Passarani warned.

Session 3 – Day One Of The New Medical Devices Regulation: Taking Stock

“Today is the day,” began the European Commission’s Paul Piscoi, speaking of the new EU Medical Devices Regulation that has just come into force. All of his colleagues in the Medical Devices Unit of the European Commission’s DG Sante division are “fully ready” for implementation, Piscoi insisted, so much so that he was literally wearing the t-shirt.

In his presentation on the current state of play of MDR, Piscoi was keen to stress the amount of work the Commission had done so far, with over 80 documents (including factsheets) published in just over four years, which, for the regulator, was “extremely fast,” he insisted. 

Nevertheless, there was “quite some” work to do to get the sector ready for the end of the transition period four years from now, for example in designating enough notified bodies to cope with an increasing certification workload that Piscoi said would peak in 2024.

This was a concern echoed by subsequent panelist, Sabina Hoekstra-van den Bosch, speaking in her capacity as vice-president of EU notified body association Team-NB. The designation process had been “much slower than anticipated,” she revealed, with the Commission’s promise of designating 20 notified bodies by the end of 2019 only fulfilled in April 2021, 15 months later.

While the average duration of the designation process of 700 days had been getting quicker, COVID-19 had slowed things down again, Hoekstra-van den Bosch noted, particularly in meeting the requirement of “on site audits”. This issue was only resolved in January this year with the publication of a Commission Notice exempting Member States from their obligation to “punish” notified bodies if they do not go onsite.

The capacity of notified bodies to meet the demand of certification was also a key concern for MedTech Europe’s director general for Industrial Policies, Oliver Bisazza, who noted in his presentation that, while the one year COVID-related delay to implementation had helped, the sector needed to remain “very attentive” to make sure there were no medical device shortages in the future.

Harmonization was also an important area of further work for Bisazza. “We wanted one set of rules that applied across EU member states,” he reflected. “That goal is good and I still think it’s the right approach. But we are not there yet.”

There were differences in application of the MDR between Member States, he pointed out, which meant that stakeholders needed to “keep working diligently” to harmonize the regulation within the EU.

The bumpy road so far had also made it hard to harmonize EU medical devices rules with those outside the region. “The EU used to be trend setters, with the CE mark being a model for approvals across the world,” he said.

Overall, Bisazza said that the book was far from closed on the MDR with it coming into force today. “If anything, we have just finished chapter one,” he said.