The Draghi report aimed at reinvigorating Europe’s economy as a whole, outlines his proposals to help the pharmaceutical sector revive its competitive edge.

On Monday, 9 September, former President of the European Central Bank and former Italian Prime Minister Mario Draghi, who saved the euro, finally set out his analysis and plan to save the European economy from “a slow agony”. 
 

Pharma in the spotlight

In summary, Draghi identifies four broad areas for improving productivity in the pharma sector. 

He wants faster and fitter authorisation processes for medicines and medical devices, ways to improve joint purchasing to support more advanced treatments, a lot more funding to help more cutting-edge research, as well as support for SMEs, and special attention paid to how data and AI, can ensure Europe keep apace with the US and Chinese markets. 

The analysis and proposals have received a warm welcome from the sector.

“If pharmaceutical companies are to catch up and compete on a level playing field, these recommendations should be actioned swiftly alongside a coherent and comprehensive life science strategy with dedicated oversight by the European Commission,” said Nathalie Moll,  director general of EFPIA.

The EU still enjoys a €45 billion trade balance advantage over the US in this sector, but Draghi’s team found that Europe is falling behind in the most dynamic market segments.

“While the EU’s pharma sector still leads globally in trade measured by value, it is falling behind in the most dynamic market segments and losing market share to US-based companies,” reads Draghi’s report. 

“The Draghi report identifies ATMPs (advanced therapy medicinal product) as a vital sector for innovation and correctly notes that the EU is falling behind in this area of medicine,” said  Paolo Morgese, Alliance for Regenerative Medicine, vice president of public affairs, Europe.

The report calls for implementing current legislation and the measures for faster medicine authorisation included in the contested Pharma Package.

AI and data mobilisation is a central theme of the report and is particularly important to healthcare.

“The report rightly calls out the need to capitalise on the potential for artificial intelligence to supercharge innovation in our industry,” said a spokesperson from Bristol Myers Squibb.

“The report’s emphasis on strengthening the European Health Data Space (EHDS), promoting multi-country clinical trials, and enhancing the use of artificial intelligence in healthcare presents a real opportunity to accelerate the development of orphan medicines,” said Virginie Bros-Facer, chief executive of Rare Diseases Europe (EURORDIS).

“We are pleased to see the report highlight joint procurement and the need to step up cross-country initiatives for joint pricing and reimbursement negotiations for specific medicines.”

The main question is where the money will come from to realise these ambitions. The EU could help the private sector step up, but ultimately public funding will play a crucial role. 

Draghi’s world-class innovation hubs in life sciences and ATMP will need funds commensurate with their ambition. 

Draghi leaves EU leaders with a stark choice, accept decline, or find a way to fill the gap with their main competitors. He concludes that this requires joint European debt.

EU invests €2 million to support work on Long COVID 

Yesterday (10 September) the Commission launched a €2 million project to address Long COVID, with the support of the OECD and the WHO. The project aims to establish a unified definition, a better understanding of prevalence, improved clinical guidelines and the launch of a stakeholder group and a citizen’s panel.

“Long COVID is not a major and global public health challenge,” said Health Commissioner, Stella Kyriakides.

100 organisations call for action on brain health

The European Brain Council (EBC) has gathered 100 supporting organisations to support their ‘No Health Without Brain Health’ campaign. On 9 September, they released a statement urging policymakers to publicly endorse brain health and research initiatives in Europe. The overall goals of the campaign are to “establish a European Parliament Intergroup on Brain Health and Research” and “support for National and EU Brain Plans.”

EU and Canada launch Health Policy Dialogue

On 9 September, Health Commissioner, Stella Kyriakides, and Canada’s Health Minister, Mark Holland, unveiled the new EU-Canada Health Policy Dialogue. The chief aim is to exchange information about antimicrobial resistance, health security and non-communicable diseases.

“Through this partnership, the EU and Canada will share knowledge, scientific evidence, and best practices to advance the health and safety of people in Europe, Canada and around the world,” said Kyriakides.

EMA recommends guidelines to minimize metamizole side effects

The European Medicines Agency (EMA) suggested ways to combat agranulocytosis, a known side effect of the painkiller metamizole. Agranulocytosis involves a dangerous lowering of the white blood cell count and can lead to serious injuries. EMA said that this side effect is not caused by the dosage level and can occur during treatment or shortly after stopping. They provided detailed information for patients and healthcare professionals on how the medicine works and when it would be best to stop taking it.

Endometriosis drug linked to potential increased risk of brain tumours

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has warned healthcare professionals about the increased risk of meningioma, a common brain tumour, in patients taking medroxyprogesterone acetate in high doses or for a long period of time. Medroxyprogesterone acetate is a medicine often used to treat hormonal conditions including endometriosis.

PRAC recommends that patients taking high doses of medroxyprogesterone acetate should be monitored for meningioma symptoms and if they are diagnosed, treatment should be stopped.

WHO delivers EU doses to the Democratic Republic of Congo

WHO and UNICEF has delivered the first 99,100 mpox vaccines donated by the European Commission’s Health Emergency Preparedness and Response Authority (HERA) to the Democratic Republic of Congo.

“WHO is working with our partners to coordinate vaccine demands, share information on doses available, and ensure those doses are directed to areas where they can contribute to controlling the outbreak,” Dr Tedros says.

New data shows a 13% increase in cholera 

The World Health Organization (WHO) has reported that cholera cases increased by 13% and resulted in over 4,000 deaths in 2023. This is a large increase from the 2,349 reported cholera deaths in 2022.

WHO completes  first phases of polio campaign in Gaza

The World Health Organization (WHO) reported that over 187,000 children aged 10 and under in central Gaza received their oral polio vaccine during the first phase of their polio vaccination campaign. 

The campaign led by UNRWA, UNICEF and WHO has been successful, but Philippe Lazzarini tweeted, “While this is good progress, civilians across Gaza continue to be killed on a daily basis including overnight in Al Mawassi which the Israeli Authorities refer to as a ‘safe zone’.”

Confirmed human bird flu with not animal exposure raises concern

On Friday, 6 September, the Missouri Department of Health reported a human case of H5 virus, it is the first incidence where the patient reported no animal exposure.

The CDC also released a statement confirming that the patient, who had unspecified “underlying medical conditions” had properly recovered and was discharged from the hospital and that additional testing was being carried out.

Sweden 

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Belgium 

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Greece

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Czech Republic

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Bulgaria

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The Netherlands 

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Hungary

11 September | Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, EMA, online

11-12 September | Committee for Advanced Therapies (CAT), EMA

12 September | Committee on the Environment, Public Health and Food Safety, talks focus on the draft budget and a report on lowering maximum residue levels of certain pesticides, European Parliament, Brussels

16-17 | Informal meeting of research ministers to discuss the Draghi report, increasing the competitiveness of the European Union and the concept of the European degree, Budapest

16-19 September | Committee for Medicinal Products for Human Use, EMA

11 September | Conference of Presidents meeting with von der Leyen to discuss future College of Commissioners, European Parliament, Strasbourg

17 September | Council recommendations on smoke free environment expected

18 September | Coreper I meeting

19 September | Working Party on Sport

*Clara Bauer-Babef, Catherine Feore, Vasiliki  Angouridi and Lydia Williams contributed to this brief.

[Edited by Rajnish Singh]

Thanks for reading. Stay healthy and see you next week! 

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Catherine Feore, Health Editor, Clara Bauer-Babef, Health Reporter