POLITICO Pro Morning Health Care: WHA turns to pandemic treaty — Ukraine mulls IP waiver — ENVI SoHO amendments

— The World Health Assembly turns to the pandemic treaty and International Health Regulations today, and we’re listing out for countries’ red lines.

— A Ukrainian MP is garnering support to waive IP for essential medicines during the war, as supplies dwindle. 

— Some of ENVI’s amendments to the substances of human origin (SoHO) draft law aren’t sitting well with a group of professional scientific associations.

Welcome to Tuesday’s Morning Health Care! Mosquito season has officially begun! Belgium’s public health agency is once again calling for help in tracking places where the aggressive tiger mosquito is seen. Why it matters: Warming weather has brought this species further north, raising the risk of cases of dengue, chikungunya and zika virus in Europe. Seen one in Belgium? Report it here. 

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PANDEMIC PREP DAY AT WHA: The World Health Assembly might not be aiming for an official outcome for either the pandemic treaty or the International Health Regulations (IHR), but there’s certainly no opportunity being lost to discuss them. With a strategic roundtable opened by WHO DG Tedros Adhanom Ghebreyesus on the topic on Monday and, today, a series of discussions expected on pandemic preparedness, it’s clear that the issue is front of mind for delegates in Geneva. 

Red lines? There are several pandemic prep items on today’s official WHA agenda, including strengthening WHO preparedness for and response to health emergencies, and the implementation of the IHR. Countries are being encouraged to engage constructively and not have “red lines” at this stage of the negotiations, so it will be interesting to see if they clearly lay down their positions or appear open to compromise. Barbara Stocking, chair of the Panel for a Global Public Health Convention told Ashleigh on Monday that “you don’t want to get into red line positions at this stage.” Read the full story here. 

Side events: It’s a frantic day of side events in Geneva, with your pick this morning including the Polish health ministry’s event on TB; the Johns Hopkins affiliated nonprofit Jhpiego and Pandemic Action Network’s event on locally initiated collaboration; and MSD and the London Global Cancer Week’s advancing access to innovative cancer care (there are many we’ve missed, see them here.) 

Then, at lunchtime, the official roundtable at the Palais is on the health care workforce — but it’s got lots of competition. At UNAIDS there’s an event on (you guessed it) the treaty and IHR amendments, hosted by South Africa’s Wits University, the Open Society Foundation, UNAIDS and the South African Mission in Geneva. 

As the sun starts to go down, the Pandemic Fund has a roundtable; the NCD Alliance and Vital Strategies will be looking at NCD “best buys”; and the WHO Economics Council will present its final report at a reception hosted by Finland. Phew!

POLITICAL STATEMENT: Ukraine, most EU countries (except Hungary) and several other nations including the U.S., have called on WHO member countries to condemn Russia’s war on Ukraine, pointing to the devastating effect on health care. If adopted this week, the draft resolution would be a political statement — territory that the WHO normally tries to steer clear of. 

**A message from PPTA: Plasma is a unique blood component that is used to make life-saving therapies for patients. Donating plasma is a more complex and lengthier procedure than whole blood donation. Plasma donations can be made more frequently than blood donations, as the human body regenerates plasma faster.**

UKRAINE’S ‘NUCLEAR OPTION’ ON MEDS IP: Medicines supplies in Ukraine aren’t meeting demand. Despite an initial flood of donations from countries and industry, packs are dwindling, arriving out of date or don’t contain what’s needed. Ukrainian lawyer Olga Gurgula is pushing for the country to take control of the situation. She’s drafted a law that, if passed by parliament, would allow it to override medicines patents during the war, enabling either local production or imports of generics.

What about compulsory licensing? There are too many barriers in Ukraine, she argues. That includes setting up a committee to establish fair compensation for the patent holder, and attempting to secure a pricing deal for every drug with every company first. Only when a company rejects a pricing offer can the government pursue a compulsory license: “What if they do not answer at all?… It could take a very long time,” she said.

Gaining traction: The text is now in the hands of two parliamentary committees where, already, one MP is backing the plan and gathering support before lodging it for parliamentary debate. The whole process could be completed in two months. Read the full story here.

UNITARY PATENT SYSTEM FINAL COUNTDOWN: You can be forgiven for dropping the ball on the progress of Europe’s unitary patent system. That’s because it’s taken nearly seven decades (SEVEN DECADES!) to be established, according to Gunnar Strömmer, Sweden’s Minister of Justice and Home Affairs. Talks on a Europe-wide patent system began even before the establishment of the European Council, Parliament and Commission (in 1958) and way before the single market jumped into action, 30 years ago. That’s why June 1, 2023, is an especially big day.

From June 1: It will be possible “to obtain patent protection in almost the entire EU, significantly lower costs and at the same time have access to a more effective dispute resolution mechanism in one court system,” said Strömmer, speaking ahead of a Council competition meeting on Monday. “It will just be easier, cheaper and more secure to protect and enforce patents in the EU.”

Generous praise: Mario Monti, who served as a European Commissioner from 1995 to 2004, first for internal markets then for competition, was forgiving of the glacial progress, even by European standards. “The history of the single market is always one of very gradual conquests of some setbacks. And overall what matters is the trend,” he said.

Antonio Campinos, president of the European Patent Office, added that “finally, Europe is a … technological market … of the dimension of the U.S. and China.” He said this will boost Europe’s GDP and high quality employment.

STRATEGY TIMING: The EU’s much-anticipated strategy on mental health is now slated for June 13, according to the tentative agenda of the College of Commissioners dated to May 17. But Morning Health hears that date is just penciled in, and that it’s actually going to come on its originally intended date of June 7.

LEGISLATIVE OBSERVATORY’S PHARMA FILE: The European Parliament’s legislative observatory has published its page for the directive part of the pharmaceutical legislation. POLITICO Pro also has it all in an easy-to-digest format here.  

DRUG SHORTAGES: Slovakia wants to clamp down on “illegal re-export” of medicines, which it says is a cause of drug shortages. “It is necessary to identify other options to sanction illegal re-exports, as well as to address this situation more comprehensively and therefore prevent shortages of medicines for Slovak patients,” said Health Minister Michal Palkovič, in a statement. He met with the national drugs regulator and pharmacists’ lobbies on Monday to thrash out the issues. The government is mulling whether to update its Medicines Act to prevent illegal exports, as opposed to legal parallel trade.

IRELAND REQUIRES CANCER WARNINGS ON BOOZE: Ireland will become the first country in the world to require alcoholic beverages to display warnings that they could potentially cause cancer, a long-awaited decision welcomed by health advocates but vociferously opposed by drinks producers worldwide. Health Minister Stephen Donnelly on Monday signed into law the regulations and confirmed that the new rules would come into effect three years from now. 

Night (re)cap: Adding health warnings was the final part of Ireland’s landmark Public Health (Alcohol) Act 2018, which aims to reduce alcohol abuse and the burden this imposes on hospitals. The plan left the booze industry up in arms and sparked a backlash in Brussels, where nine member countries filed objections. 

Tee-total: Europe’s alcohol lobbies and agricultural associations slammed Ireland’s plans as an attack on drinking in moderation, as well as the single market. But the trade and competition authorities of the EU and World Trade Organization chose to back the medical evidence rather than industry warnings.

Now, EU: In a letter to EU Commission President Ursula von der Leyen, a coalition of civil society leaders, headed by the European Alcohol Policy Alliance (Eurocare), has called on the Commission to follow Ireland’s lead in its proposal for an EU-wide labeling regime. “We are very concerned that this important legislation will not see the light of day before the end of the current mandate,” said the coalition’s letter. Shawn Pogatchnik has the story.

SUBSTANCES OF HUMAN ORIGIN

UNWANTED AMENDMENTS: Lawmakers in the European Parliament’s ENVI committee have a lot to say about the substances of human origin (SoHO) draft law, with hundreds of proposed amendments to the text put forward by the European Commission. Some of those aren’t sitting well with the Common Representation of Substances of Human Origin (CoRe SoHO), a group which includes the European Blood Alliance, European Eye Bank Association, European Association of Tissue and Cell Banks, and the European Society for Blood and Marrow Transplantation. 

Chop chop: In a letter sent on Monday to MEPs in the ENVI committee and obtained by POLITICO, the organization takes aim at, among other things, amendments that propose scrapping text about the role of the public and non-profit sectors in providing SoHO services. “The public and non-profit sector are fundamental to ensure a resilient and sustainable provision of all SoHO services to all Europeans and their role must be recognised and encouraged in the Regulation, as per the original proposal from the European Commission,” the letter reads. SoHO collection varies across the bloc, with four countries having both public and private sector plasma collection, for example. 

Listen in: The organization is sharing its take on the draft law during an event at the European Parliament today. 

Next up: The vote on the report in the ENVI committee was slated for June 27, but Morning Health hears that it’s now been pushed back to July — so stay tuned. 

Novo Nordisk says trial of oral weight-loss drug shows significant result, while Pfizer’s diabetes drug results in similar weight loss levels as Novo’s Ozempic, reports Reuters.

Meanwhile, The Atlantic looks at whether scientists accidentally invented an anti-addiction drug with Ozempic.

Scientists discover brain signals for chronic pain, from The Guardian.

Do chatbots have more time to be empathetic than physicians, asks STAT.

**A message from PPTA: Plasma can be obtained from whole blood donations (known as ‘recovered plasma’) or collected directly through a process called plasmapheresis (known as ‘source plasma’). Plasmapheresis is more efficient and can be done more frequently. However, it requires greater commitment from the donor, as it generally takes up to four times longer than whole blood donation. The frequency of plasma donation by plasmapheresis is regulated. In the EU, individual country authorities permit a maximum of up to 60 donations per year. Data show no increase in donor adverse events with repeat donation, even in countries with much higher permitted donation frequencies. This is good news as hundreds of donations are needed to treat one patient with a lifelong condition for just one year. Europe needs more plasmapheresis.**