European lawmakers are focusing their tweaks of the reform of the EU framework for substances of human origins on how donations of these substances should be carried out.
In July, the EU executive presented a proposal to overhaul the current legislation on tissues, blood, and cells since rules and parameters on the matter were set more than 20 years ago.
The revision involves all the procedures that ensure the safety of donors and recipients of blood, plasma, skin, embryo, sperm, and corneas – with the recent addition of breast milk and microbiota.
MEPs have already started working on a draft report featuring amendments to the EU executive’s proposal – which also replaced the acronym for the framework from an old-school-sounding BTC (which stands for blood, tissue, and cell) to the fancier SoHo (substances of human origins).
Once the Parliament agrees on their tweaks to the Commission’s text, they will start negotiations with EU ministers for final approval of the reform. This feasible timeline makes the SoHo revision one of the last health files to be discussed by lawmakers- and perhaps concluded – before the end of the current legislative mandate in spring 2024.
The first debate on the topic took place in the European Parliament’s environment and health committee (ENVI) last week and focused on one of the most divisive problems – voluntary unpaid donations (VUD) in the EU.
The VUD principle is in line with the EU Charter of Fundamental Rights which prohibits the commercialisation of the human body but “does not prevent compensation of living donors for loss of earnings and reimbursement of any other justifiable expenses related to the medical procedure”.
The ‘substance’ of the SoHo problem is in a two-faced legislative framework when it comes to VUD: On one side, conditions under which compensation may be granted are left to member states’ discretion, on the other, there is no such definition of compensation in the EU law.
Both the national competence and the uncertainty around the term have led to inconsistent approaches among member states, reducing the harmonisation in the EU and undermining the single market.
There are currently very different national interpretations related to these forms of incentives to donate, ranging from tax benefits to paid days off work.
During the debate in ENVI, MEPs warned about the risks of not setting clear bases for these procedures, which can vary from country to country, asking for more concrete regulation on the matter.
For the Spanish socialist MEP Nicolás González Casares, the Commission’s proposal leaves some degree of ambiguity when it comes to the VUD definition. “I think we definitely need to avoid that in a European approach,” he said.
The Parliament’s rapporteur on the file, the French centre-right Nathalie Colin-Osterlé, stressed the need to “harmonise the implementation of the principle of voluntary and unpaid donation in particular to avoid divergence between national regulations encouraging citizens to go to a member state other than their own [to donate] just for financial reasons”.
After the MEPs spoke, a Commission representative acknowledged that Parliament’s draft report “aims to reinforce even more a certain number of measures, already in the proposal, in relation to the modalities of application of the principle of voluntary and unpaid donation”.
“A couple of the amendments suggested and proposals made will need to be considered carefully as we further work,” the Commission representative pointed out.
As expected, this issue is also discussed beyond the Parliament – particularly as it remains an ‘open wound’ when it comes to plasma donation.
“We believe that compensating donors with a ‘fixed-rate allowance’ – for which member states set the conditions – is compatible with the VUD principle,” Maarten Van Baelen, executive director at Plasma Protein Therapeutics Association (PPTA), told EURACTIV.
According to him, the concept of quantified losses is ‘ill-advised and vague’ while the wording in the current framework – ‘“donors may receive compensation, making good the expenses and inconveniences related to the donation” – should be kept in the revision.
Contacted by EURACTIV, the European Blood Alliance, which represents more than 80% of the EU’s blood services, also welcomed “a clearer definition of compensation, which is currently too broad and vague, as well as a clearer European framework on how member states can ensure that financial neutrality is respected, in particular when fixed rate allowances are considered”.
The deadline for tabling amendments to the Parliament’s report is set today (8 March) but there will be still time to ‘substantiate’ all the different claims on VUD in what promises to be something to keep an eye on in the coming months.
By Marta Iraola and Gerardo Fortuna
——————————————————————————————
Today’s edition is powered by IMDRF23
Want to stay up to date about recent developments in the medical device sector? Register for free for the IMDRF 23rd session at Autoworld Brussels on 27-28 March 2023 and hear from global regulators, industry and healthcare professionals on the latest developments. Not to be missed: special sessions on Artificial Intelligence in the health field.
Register for free >>
——————————————————————————————
Subscribe to EURACTIV’s Health Brief, where you’ll find the latest roundup of news covering health from across Europe. The Health Brief is brought to you by EURACTIV’s Health Team Giedrė Peseckytė, Clara Bauer-Babef, Marta Iraola, and Gerardo Fortuna.
Be also sure to listen to the new EURACTIV’s Health Podcast!
This week, EURACTIV’s journalists Clara Bauer and Gerardo Fortuna sat with the EU’s health Commissioner Stella Kyriakides to talk about women’s health on the occasion of International Women’s Day. The EU health chief also gave some anticipations on what is coming up next in the EU’s health policy agenda.
Medical devices regulation. On Tuesday (7 March) the Council adopted a regulation which extends the deadline for the certification of medical devices. This measure aims to prevent medical devices that cannot be certified by the initial cut-off date from becoming unavailable for European patients. “Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices,” said Acko Ankarberg Johansson, Swedish minister for health care. Producers of medical devices will now have to meet the legal requirements until 31 December 2027 for higher-risk devices and until 31 December 2028 for medium and lower-risk devices.
The extension of the transition period will be granted under certain conditions. These ensure that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.
The regulation adopted today also reduces the risk of medical device shortages by removing the ‘sell-off” date rule. The “sell-off” date is the end date after which devices already on the market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from this rule. Removing the “sell-off” date will allow safe medical devices to remain longer on the market.
MedTech Europe welcomed the adoption of amended transitional provisions of the Medical Devices Regulations and called for continued work to address outstanding implementation challenges. “The amendment of the Medical Devices Regulations’ transitional provisions is a needed step forward to help ensure that more medical devices remain available to patients and healthcare systems across Europe,” said Oliver Bisazza, CEO of MedTech Europe. He added that “this decision grants notified bodies more time to complete certification of more than 500.000 medical devices and accelerates efforts to certify innovative devices in the pipeline”.
COVID report. EU lawmakers shared an overall positive view of the final draft report of the European Parliament’s special committee on COVID-19 (COVI). Still, some of them voiced criticism over the part on intellectual property rights and the social impact of the pandemic.
The Health Data revolution. Access to secondary use of data – one of the thorniest issues of the European Health Data Space dossier – is crucial “if we want to bring investments to Europe in the area of healthcare,” according to European Parliament’s rapporteur Tomislav Sokol. “This is why we are not creating a one-size-fits-all system, one giant database, but we want to have this flexibility so that different players can enter this market and have different health applications and digital solutions,” he said in last week’s EURACTIV health podcast.
Respiratory diseases. A study published in the scientific journal The Lancet on Tuesday (7 March) found that respiratory infections contracted during early childhood increase the risk of death from respiratory illness between the ages of 26 and 73 years. People who had a lower respiratory tract infection, such as bronchitis or pneumonia, by the age of two were 93% more likely to die prematurely from respiratory disease as adults, regardless of socioeconomic background or smoking status. “Current preventative measures for adult respiratory disease mainly focus on adult lifestyle risk factors such as smoking. Linking one in five adult respiratory deaths to common infections many decades earlier in childhood shows the need to target risk well before adulthood,” said James Allinson, lead author of the study.
Global agreement on pandemic prevention. On Friday (3 March) countries of the World Health Organisation have begun negotiations on a global agreement on pandemic prevention, preparedness and response, using the “zero draft” as a basis for negotiating an agreement to protect nations and communities from future pandemic emergencies. Ending Friday, discussions on the draft pandemic accord took place during the fourth weeklong meeting of the Intergovernmental Negotiating Body (INB), which includes WHO’s 194 countries.
Roland Driece from the Netherlands, co-chair of the INB Bureau, said: “The start of discussions of concrete language for the WHO pandemic accord sends a clear signal that countries of the world want to work together for a safer, healthier future where we are better prepared for, and able to prevent future pandemic threats, and respond to them effectively and equitably.”
WHO member states will continue negotiations of the zero draft of the pandemic accord at the INB’s next meeting, to be held over 3-6 April, with a view to collecting all inputs necessary to develop the first draft.
According to the process agreed by governments at a special session of the World Health Assembly in late 2021, negotiations on the draft pandemic accord will aim to produce a final draft for consideration by the 77th World Health Assembly in 2024.
Preventing and Addressing Sexual Misconduct. On Friday (3 March) The World Health Organisation launched its Policy on Preventing and Addressing Sexual Misconduct which sets strict standards of zero tolerance and stresses that there can be “no excuse” for sexual misconduct. The new policy replaces a 2017 policy, in which investigations and audits found gaps in addressing the problems faced by victims and survivors of sexual misconduct. The policy covers WHO staff and collaborators (consultants, contractors, partners) in locations where WHO operates, and sets six minimum standards to protect anyone subject to sexual misconduct by WHO staff or collaborators. “The suffering of the survivors of the abhorrent cases of sexual misconduct during the response to the 10th Ebola outbreak in DRC has been the catalyst for a profound transformation of WHO’s approach to preventing and responding to sexual exploitation, abuse and harassment,” said Tedros Ghebreyesus, WHO director-general. He added that “this new policy builds on the work we have already done in implementing the recommendations of the Independent Commission, and is a key part of making ‘zero tolerance’ a reality and not merely a slogan”.
Violence against women. On Wednesday (1 March) 2021-2022 impact report, ‘Driving Change For a Better Tomorrow’ from the United Nations showed that the ‘Spotlight Initiative to eliminate all forms of violence against women and girls’ has helped 1.6 million women worldwide to access gender-based violence services since it launched in 2017. The global Spotlight Initiative to eliminate violence against women and girls is a United Nations initiative supported by the European Union and other partners. In 2021 alone, the Spotlight Initiative more than doubled conviction rates for perpetrators of gender-based violence, signed or strengthened 198 laws and policies to eliminate violence against women and girls in 41 countries, and educated more than 1.3 million men and boys on non-violent conflict resolution and positive masculinity.
Food advertising in Germany. Marketing targeted at children and advertising food with too much fat, sugar, or salt could soon be banned in Germany, according to plans presented by Green agriculture and food minister Cem Özdemir.
WARSAW
Polish parliament rejects controversial abortion bill before elections. Parliament rejected a controversial bill that aims to further tighten one of the strictest abortion laws in Europe on Tuesday, with some conservative members of the ruling PiS saying off the record that they did not want the bill to cause a new wave of street protests ahead of the upcoming elections. By Aleksandra Krzysztoszek | EURACTIV.pl
The European Commission allowed Poland to renegotiate the agreement with Pfizer on the deliveries of COVID-19 vaccines, a groundbreaking step amid long-time resistance of the EU executive to permit member states from requesting to change the conditions of the EU-concluded deal. By Aleksandra Krzysztoszek | EURACTIV.pl
PARIS
France seizes ‘historic’ 157 tons of drugs in 2022. More than 150 tons of illegal drugs were seized by French authorities in 2022, marking a “historic” win against Home Minister Gérald Darmanin’s self-dubbed “mother of all fights”. By Théo Bourgery-Gonse | EURACTIV.fr
8 March – Workshop on EU crisis preparedness and response – European Parliament’s COVI Committee
9 March – Workshop on Long Covid – European Parliament’s COVI Committee
9 March – Launch of the WHO’s Inequality Monitoring in Sexual, Reproductive, Maternal, Newborn, Child and Adolescent Health eLearning course
9 March – ‘Redefining self-care in Europe’ event hosted by MEP Kympouropoulos
9 March – Towards eradicating cervical cancer
9 March – Launch of the WHO Global report on sodium intake reduction
10 March – Webinar ‘ChatGPT and (pain) research – opportunity or threat?’
13-16 March – European Parliament’s plenary
14 March – EU ‘health’ Council
14-15 March – #ShiningALight exhibition in Strasbourg
27-28 March – International Medical Devices Regulators Forum