Working together on health and vaccine passports

Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update. 2021 has been a very busy year for EAPM, with much to look forward to in 2022 with the implementation of the EU cancer plan, EU Health Space, Pharma Strategy as well as other legislative and policy dossiers. EAPM will have one more update next week, then will be off for the Christmas break from 23 December, writes EAPM Executive Director Dr. Denis Horgan.

Working together on travel

EU leaders agreed on Thursday (16 December) on the need for continued coordination on travel without giving any details on when changes would be made. 

In the European Council conclusions on COVID-19, leaders attending the summit agreed that any additional measures shouldn’t hamper free movement inside the bloc too much.

And the Council conclusions urged speedy adoption of the European Commission’s revised proposals on co-ordinated EU travel, which includes limiting vaccine certificates to nine months unless the holder gets a booster shot. But while the agreed text noted the Commission would adopt a delegated act on the issue, it also didn’t say when that would occur.

New four-year drug pricing and supply agreement in Ireland

Ireland and its innovative medicines sector have agreed to a new four-year drug pricing and supply agreement. The government has secured price reductions for patent-expired products and biosimilars, as well as increasing rebates on branded medicine sales to be paid back to the health ministry each year. These rebates will start at 7.75% in 2022 and rise to 9% in 2025. In addition, the ministry has agreed to build its capacity to review more new treatments each year to bring them to market more quickly, the industry lobby group IPHA said. 

Empowering Citizens and Big Tech Companies

Big tech companies are set to face unprecedented restrictions after EU lawmakers on Wednesday (15 December) backed a package of rules geared at reining in the power of technology giants. Two major EU pieces of legislation are about to change the digital landscape. The European Parliament has approved its position on the Digital Markets Act (DMA), introducing changes to rules on digital markets that will fundamentally affect tech giants and users alike. For example, dominant platforms will now have to provide their interfaces to smaller companies, bringing competition back to digital markets.

According to the proposal's shadow rapporteur, Pirate Party MEP Marcel Kolaja, this will facilitate communication for users across social networks. Czech Pirate Party Vice President Marcel Kolaja MEP said: "The Digital Markets Act is a really important step for Europe. We can expect that the rules for the European market will also influence digital markets globally, just as it has happened for instance with the rules on data protection. Moreover, the Parliament has sent an important message to the world today. Namely, that the protection of users, their privacy and their right to a fair choice of Internet services is at the very heart of these rules." Over the past two decades, digital platforms have become an integral part of our lives - it’s hard to imagine doing anything online without Amazon, Google or Facebook. 

While the benefits of this transformation are evident, the dominant position gained by some of these platforms gives them significant advantages over competitors, but also undue influence over democracy, fundamental rights, societies and the economy. They often determine future innovations or consumer choice and serve as so-called gatekeepers between businesses and internet users.

Implementation of vaccine certificate deadline causes split

A proposal to limit the validity of vaccination certificates to nine months unless a booster dose is applied is being held up as EU capitals argue over its implementation.

EU diplomats said member countries agree on the need to set a nine-month limit for vaccine certificates. That duration is meant to address the waning immunity that a standard vaccine course provides against the coronavirus — unless a booster dose is administered.

But, according to Belgian Prime Minister Alexander De Croo, it has not yet been decided when the new measure should be introduced. He said two start dates were being discussed: February 1 and March 1.

The European Commission last month proposed setting the duration of vaccine certificates, or “green” passes, for travel to nine months. Beyond that, travelers would have to receive an extra vaccine dose.

WHO financing 

World Health Organization countries meet today (17 December) to discuss what’s been one of the most difficult issues facing the organization — funding. It’s clear that the expectations countries have “far outweigh what WHO can indeed achieve because of limited resources … primarily because of limited sustainable finances,” Björn Kümmel, chair of the Working Group on Sustainable Financing and deputy head of the global health division at Germany’s health ministry, told a briefing. 

The vast majority of the WHO’s funding comes from voluntary contributions from its members, with just 16% from assessed contributions. The working group will today recommend that countries’ assessed contributions cover 50% of the base programme budget. This increase would only start in 2024 and would be implemented gradually, with the target being met in the financial year 2028 to 2029.

Lower legal burden 

The lead lawmaker on a EU product safety law wants to lower the legal burden for companies selling goods that are deemed riskless for consumers, according to a draft report seen by Morning Tech. Renew MEP Dita Charanzová’s draft report on the General Product Safety Regulation wrote the Commission shouldn’t force small and medium-sized companies from third-countries to appoint an EU legal representative, known as a “responsible person,” when they sell harmless products (think birthday cards or pens). Charanzová suggested that the Commission should clarify which companies require legal representation, and look into their market size. 

“We must be careful in not imposing a disproportionate burden on economic operators with the only effect of killing the growth of e-commerce and of closing the EU market to third countries operators,” she said.

Commission launches its own cloud alliance

The new European Commission-powered Alliance for Industrial Data, Edge and Cloud was officially launched on Tuesday (14 December). With 39 members, the initiative gathers some of Europe’s top-notch tech companies to collaborate on next-generation computing technologies.

“Data will transform the way we produce, consume and live”, said Internal Market Commissioner Thierry Breton, who chaired the kick-off meeting.

“With energy-efficient, highly secure and interoperable solutions, we will enable the uptake of new digital technologies, provide businesses and public administrations with a trusted framework to process data, and strengthen the position of EU industry,” he added.

Erecting solutions to fake viagra

Large quantities of counterfeit drugs and supplements for erectile dysfunction were intercepted between April and October 2021, according to the European Anti-Fraud Office (OLAF), as part of Europol’s Operation SHIELD II. Viagra, the first oral drug in the US specifically prescribed for impotency, was approved by the Food and Drug Administration in 1998; Cialis got its stamp of approval in 2003. That means the war against phony erectile dysfunction (ED) drugs has been raging for years. Some $16.3 million in counterfeit ED drugs were confiscated in the 12 months that ended 30 September. 

G7 countries warn Omicron ‘biggest threat to global public health’

Health ministers from the world’s seven richest democracies agreed on Thursday (16 December) that the Omicron coronavirus variant that is surging across Europe and other parts of the world is the “biggest threat to global public health”.

Working together and sharing information will be “crucial” in responding to the rapidly growing Omicron wave, G7 health ministers agreed in the final meeting of the UK’s G7 presidency.

The UK recorded more than 88,000 new coronavirus infections on Thursday, with Omicron cases driving the surge. The country has now registered more than 49,000 cases of Omicron total, while in Denmark, a country with a population of around 6 million and another Omicron hotspot, more than 9,000 Omicron cases have now been recorded.

And that is everything from EAPM at the end of the week – have a nice weekend. 

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