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Promoting innovation and access to affordable medicinal products
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Specific rules for novel medicines such as orphan drugs and antimicrobials
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Medicines to become more environmentally sustainable
MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.
On Tuesday, the Environment, Public Health and Food Safety Committee adopted its position on the new directive (66 votes in favour, two against and nine abstentions) and regulation (67 votes in favour, six against and seven abstentions) covering medicinal products for human use.
Regulatory data and market protection: incentives for innovation
To reward innovation, MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a marketing authorisation.
Pharmaceutical companies would be eligible for additional periods ofdata protectionif the particular product addresses an unmet medical need (+12 months), if comparative clinical trials are conducted for the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a cap on the combined data protection period of eight and half years.
A one-time extension (+12 months) of the two-yearmarket protectionperiod could be granted if the company obtains a marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.
Orphan drugs(medicines developed to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a “high unmet medical need”.
Step up the fight against antimicrobial resistance (AMR)
MEPs underline the need to boost the research and development ofnovel antimicrobials, notably through market entry rewards and milestone reward payment schemes (e.g. early-stage financial support upon achieving certain R&D objectives prior to market approval). These would be complemented by a subscription model-based voluntary joint procurement scheme, to encourage investment in antimicrobials.
They agree with the introduction of a “transferable data exclusivity voucher” for priority antimicrobials, providing for a maximum 12 additional months of data protection for an authorised product. The voucher could not be used for a product which has already benefited from maximum regulatory data protection and would be transferable only once to another marketing authorisation holder.
Among the new measures to promote the prudent use of antimicrobials, MEPs want stricter requirements, such as restricting the prescriptions and dispensation to the amount required for the treatment and limiting the duration for which they are prescribed.
Strengthened requirements for environmental risk assessment
These new rules would require companies to submit an environmental risk assessment (ERA) when requesting a marketing authorisation. To ensure adequate evaluation of ERAs, MEPs want the creation, within the European Medicines Agency, of a new ad-hoc environmental risk assessment working party. MEPs insist that the risk mitigation measures (taken to avoid and limit emissions to air, water and soil) should address the entire life cycle of medicines.
Increased independence for EU health emergency body
To effectively address public health challenges and boost European research, MEPs want the EuropeanHealth Emergency Preparedness and Response Authority(HERA, currently a Commission department) to become a separate structure under the European Centre for Disease Prevention and Control (ECDC). HERA should primarily focus on the fight against the most urgent health threats, including antimicrobial resistance and medicine shortages.
More details on MEPs’ specific proposals are available in thisbackground document.
Quotes
Rapporteur for the directivePernille Weiss (EPP, DK)said:
“The EU pharmaceutical legislation revision is vital for patients, industry and society. Today’s vote is a step towards delivering the tools to tackle present and future healthcare challenges, particularly for our market attractiveness and medicine access across EU countries. We hope Council takes note of our ambition and commitment to create a robust legislative framework, setting the scene for prompt negotiations.”
Rapporteur for the regulationTiemo Wölken (S&D, DE)said:
“This revision paves the way to addressing critical challenges such as medicines shortages and antimicrobial resistance. We are strengthening our healthcare infrastructure and reinforcing our collective resilience ahead of future health crises – a significant milestone in our pursuit of fairer, more accessible healthcare for all Europeans. Measures improving access to medicines, whilst incentivising areas of unmet medical needs, are crucial parts of this reform.”
Next steps
MEPs are scheduled to debate and vote on the Parliament’s position during the 10-11 April 2024 plenary session. The file will be followed up by the new Parliament after the European elections on 6-9 June.
Background
On 26 April 2023, the Commission put forward a “pharmaceutical package” to revise the EU’s pharmaceutical legislation. It includes proposals for a newdirectiveand a newregulation, which aim to make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, with higher environmental standards.
Source : © European Union, 2024 – EP
EVP/CDU zu Pharma-Paket und Antibiotika
Der Umwelt- und Gesundheitsausschuss des Europaparlaments hat heute über das sog. Pharma-Paket abgestimmt. Dabei wurde ein Vorschlag zu Vouchern, also Gutschriften für Firmen, die neue Antibiotika entwickeln, angenommen. Dazu erklärt Peter Liese (CDU), gesundheitspolitischer Sprecher der EVP-Fraktion:
„Das ist ein großer Durchbruch bei der Bekämpfung von Antibiotikaresistenzen. Natürlich müssen wir alle sorgsamer mit Antibioktika umgehen. Aber gerade wenn neue Antibiotika praktisch in den Panzerschrank kommen, damit nicht sofort wieder Resistenzen entstehen, ist der Anreiz für die Industrie entsprechend gering. Deswegen bin ich sehr froh, dass wir jetzt ein System einführen, dass Unternehmen, die neue Antibiotika auf den Markt bringen, eine Gutschrift für Marktexklusivität bekommen. Diese Gutschriften können sie an andere Firmen verkaufen, die damit entsprechend Gewinne machen. Das bedeutet zwar Kosten für die Leistungsträger, zum Beispiel in Deutschland für die Krankenkassen. Aber wenn wir damit nur einen Teil der 35.000 Leben retten können, ist es meiner Ansicht nach die Sache wert.
Insgesamt fördert der Beschluss des Ausschusses gezielt Innovationen, die uns bei der medizinischen Versorgung unserer Bürgerinnen und Bürger weiterbringen. Der Unterlagenschutz, das heißt, die Zeit, bis die günstigen Nachahmerprodukte (Generika) auf den Markt kommen, wird gegenüber dem Kommissionvorschlag von sechs auf siebeneinhalb Jahre erhöht. Der Ausschuss unterstützt aber das Konzept der Kommission, dass man die Unternehmen, die besondere Anforderungen erfüllen, deutlich besserstellt. Wer ein Medikament auf den Markt bringt, das einen echten Fortschritt bedeutet und einen bisher nicht abgedeckten medizinischen Bedarf abdeckt (‚unmet medical need‘), bekommt ein weiteres Jahr Unterlagenschutz. Ebenso gibt es Anreize, wenn die klinischen Prüfungen in Europa durchgeführt werden. Für Firmen, die sich also entsprechend orientieren, ist es in Zukunft attraktiver, Arzneimittel auf den europäischen Markt zu bringen. Ich hätte mir hier noch mehr Anreize vorstellen können, aber der Beschluss ist ein guter Kompromiss zwischen der Notwendigkeit für Innovation und der Wirtschaftlichkeit.“
Hintergrund
Seit Jahren besteht das Problem, dass jährlich 35.000 Menschen an Keimen sterben, gegen die kein Antibiotikum mehr wirkt, Tendenz steigend. Deswegen fordert die christdemokratische EVP-Fraktion schon seit langem, dass es verstärkte Anreize für neue Antibiotika geben muss.
Das sog. “Pharma-Paket” besteht aus einer Richtlinie (Richtlinie zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der
Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG) und einer Verordnung (Verordnung zur Festlegung der Verfahren der Union für die Zulassung und Überwachung von Humanarzneimitteln und zur Festlegung von Vorschriften für die Europäische Arzneimittel-Agentur, zur Änderung der Verordnung (EG) Nr. 1394/2007 und der Verordnung (EU) Nr. 536/2014 sowie zur Aufhebung der Verordnung (EG) Nr. 726/2004, der Verordnung (EG) Nr. 141/2000 und der Verordnung (EG) Nr. 1901/2006). Der Gesundheitsausschuss hat heute über diese beiden zusammenhängen Gesetzgebungsvorschläge abgestimmt.
Strong S&D footprint in outcome of vote on the pharmaceutical package
MEPs, led by the S&Ds, voted today on the landmark ‘pharmaceutical package’ in the European Parliament’s committee on environment, health and food safety. Its goal is to ensure better access, availability and affordability of medicines in the Union.
The S&D Group has been calling for a European Health Union since March 2020, with the ‘pharmaceutical package’ as its centrepiece. The pandemic highlighted critical shortages and the disparity in access to medicines across EU member states, but also between wealthier and poorer citizens – an unacceptable situation for the Socialists and Democrats.
Against intensive industry lobbying, the S&Ds managed to negotiate a compromise which improves and modernises the regulatory framework, as well as takes steps towards addressing underserved disease areas and access to medicines across all EU countries.
Tiemo Wölken, S&D coordinator for the environment, health and food safety committee and European Parliament’s lead negotiator on the regulation of the ‘pharmaceutical package’, said:
“Today’s committee vote on the ‘pharmaceutical package’ marks a step forward in our pursuit of a fairer, more accessible healthcare system for all citizens of the European Union and a more robust pharmaceutical framework. As a group, we pushed for improved access to medicines, while addressing critical challenges such as shortages and antimicrobial resistance. The update of this legislation is badly needed to not just strengthen our healthcare infrastructure, but also to reinforce our collective resilience in the face of future health crises.”
“Under the S&Ds’ leadership, the package puts forward measures to tackle shortages of medicinal products, such as a stronger transparency and reporting requirements for manufacturers and wholesalers. Moreover, we significantly strengthened communication and transparency towards patients and healthcare professionals. At the same time, it encourages innovation by supporting research on solutions to unmet medical needs, especially in the area of rare diseases.
“Thanks to the S&Ds, this new legislation calls for the prudent use of antimicrobials and the development of new ones to curb the growing threat of antimicrobial resistance, which is responsible for over 35,000 deaths every year in the European Union. Overuse of antimicrobials leads to resistance, making infections harder to treat and increasing the risk of disease transmission, severe illness, and death. With the creation of incentives like milestone payments, we want to support companies throughout the whole development process of novel antimicrobials. The possibility for joint procurement of antimicrobials coupled with a subscription model payment system will generate income without having to push the new drug to the market, hence delinking the volume of sales from the contract and helping to overcome market failures.
“Learning from the Covid-19 pandemic, this law will make the regulatory framework more efficient by shortening the duration for marketing authorisation and creating an accelerated process for approving medicines, benefiting both regulators and companies involved in medicine production.”
Nicolás González Casares, S&D MEP and negotiator on the directive of the ‘pharmaceutical package’, said:
“The revision of the pharmaceutical legislation is a very much needed step forward towards a stronger European Health Union. This legislative package aims to ensure innovative, effective, safe, accessible and affordable medicines for all Europeans, while fostering pharmaceutical research and innovation in Europe and minimising the impact of pharmaceutical contamination on the environment.
“Patients’ needs were always at the centre of all amendments tabled by the S&Ds. Nowadays in the EU, there are unacceptable inequalities between member states, with some patients only getting access to the treatments years after they were authorised. This is related to high prices of innovative medicines and specific commercial interests. In this revision, we asked for more transparency in the public funding that pharmaceutical companies receive, to ensure fairer prices and return on public investments. We also prohibited unlawful patent linkage so that affordable generic medicines can reach the market as soon as possible, creating competition and increasing accessibility.
“During the negotiations, the S&Ds managed to increase the measures set by the Commission regarding environmental protection, requesting an environmental risk assessment for the whole life cycle of medicines, including manufacturing inside and outside the EU, to create a level playing field.
“Regarding the scheme of incentives that the innovative pharmaceutical industry receives when placing new medicines in the European market, despite the intense external pressure, the S&Ds managed to control the excessive data and market protection that other groups were requesting. While innovation should be incentivised and rewarded, it should never be done in a way that poses unbearable pressure on our public health systems or that hampers access for patients.”
Europa-SPD: Gesundheitsausschuss stimmt für Pharmapaket – Dringend notwendige Modernisierung
VON TIEMO WÖLKEN
Die Europa-Abgeordneten im Gesundheitsausschuss des EU-Parlaments haben soeben in Brüssel mehreitlich für das europäische Pharmapaket votiert. Das Paket besteht aus einer Verordnung sowie einer Richtlinie. Ziel der neuen Vereinbarungen ist, den Zugang, die Verfügbarkeit und die Erschwinglichkeit von Arzneimitteln in der Union zu verbessern sowie Arzneimittel-Engpässen entgegenzuwirken. Zudem sollen die neuen Regeln die Zulassung von Medikamenten in der Union vereinfachen.
Die S&D-Fraktion hatte seit März 2020 eine europäische Gesundheitsunion, deren Kernstück das Pharmapaket ist, gefordert.
Tiemo Wölken, gesundheitspolitischer Sprecher der S&D-Fraktion im Europäischen Parlament und Berichterstatter der Verordnung:
„Dieses Paket kann den Zugang zu Arzneimitteln sowie die Lage unterversorgter Krankheitsgebiete in allen EU-Staaten verbessern – trotz intensiver Lobbyarbeit der Industrie gegen sinnvolle Regelungen. Die Modernisierung dieser über zwanzig Jahre alten Gesetzgebung ist dringend notwendig, um die Gesundheits-Infrastruktur in der EU zu stärken und die kollektive Widerstandsfähigkeit gegen künftige Krisen zu stärken.
Das Pharmapaket enthält Maßnahmen gegen Arzneimittelknappheit, zum Beispiel strengere Transparenz- und Meldepflichten für Hersteller und Großhändler. Zudem übernimmt die EU damit Führungsstärke, indem die Staatengemeinschaft künftig Konzepte zur Analyse der Sicherheit koordiniert, ebenso wie Pläne zur Studie der Wirksamkeit, Qualität und Zugänglichkeit von Arzneimitteln für Bürger:innen. Gleichzeitig stellen die EU-Staaten so den Zugang zu innovativen und etablierten Arzneimitteln sicher, die die die Umwelt weniger belasten.
Für den überwältigenden Teil der bekannten seltenen Krankheiten gibt es noch immer keine Behandlung. Künftig fördert die EU deshalb besonders, durch gezielte Anreize für Arzneimittel-Hersteller, die Forschung und Entwicklung von dringend notwendigen Arzneimitteln in höchst unterversorgten Gebieten.
Das neue Gesundheitspaket fördert den umsichtigen Einsatz von Antibiotika und schafft Anreize zur Entwicklung neuer Antibiotika, um die wachsende Bedrohung von Resistenzen einzudämmen. Antibiotika-Resistenzen verursachen jedes Jahr mehr als 35.000 Todesfälle in der EU. Der übermäßige Einsatz antimikrobieller Mittel führt zu Resistenzen, die die Behandlung von Infektionen erschweren und das Risiko der Übertragung von Krankheiten, schwerer Erkrankungen sowie von Todesfällen erhöhen.
Als Lehre aus der Pandemie verkürzt das Pharmapaket die Dauer für die Marktzulassung und ermöglicht ein beschleunigtes Verfahren für die Zulassung von Arzneimitteln, wovon sowohl Arzneimittel-Hersteller als auch die Europäische Arzneimittelagentur profitieren werden.“
Die Gesamtheit der Europaabgeordneten wird voraussichtlich am Donnerstag, 11. April, im Miniplenum in Brüssel über das Pharmapaket entscheiden.
Renew Europe: New pharmaceutical package provides prescription to safeguard the availability, affordability and equal access of medicines for all Europeans
The revision of the pharmaceutical package approved this afternoon in ENVI Committee has the full support of Renew Europe as it strikes the right balance of ensuring adequate incentives for conducting research and development for new medicines, while also improving access and availability in the entire EU. The revision ensures greater harmonisation of the internal market of medicinal products and speeds up the process of getting medicines approved, introduces new tools to counter shortages of medicines, enables the extension of joint purchasing and will improve the availability, affordability and equal access of medicines for all Europeans.
The Renew Europe group would also like to highlight the work done by both Renew Europe shadows, whose negotiating skills have led to a future-proof pharmaceutical package that benefits public health. Thanks to the efforts of Mrs. Frédérique Ries and Mrs. Catherine Amalric, Renew Europe has secured key priorities for the group, such as:
- A new provision for the establishment of a European Framework for Rare Disease to enable successful orphan medical products and tailor – made healthcare for those patients, while guaranteeing extended group purchasing of medicines for the treatment of rare and chronic diseases or antibiotics.
- Equal access to contraceptive and abortifacient medicines for all women across the EU by lifting the possibility of banning or restricting the purchase and the use of those medicinal products.
- Strengthening the European pharmaceutical ecosystem, by introducing new incentives for research and development.
- Countering the threat of antimicrobial resistance by combining the transferable exclusivity voucher with a push and pull mechanism to stimulate the development of new antimicrobials.
MEP Catherine Amalric, (Parti Radical, France) shadow rapporteur for the directive on medicinal products for human use says:
“This a huge victory for the Health Union. Today’s vote will lead the way towards a real Europe for medicines. The revision of European pharmaceutical legislation will give all European citizens access to fairer, safer and more sustainable medicines, while enabling the production of medicines to be relocated in Europe and encouraging research and innovation.”
MEP Frédérique Ries (MR, Belgium) shadow rapporteur for the regulation of medical products for human use comments:
“Imagine a world where the health of Europeans is a priority, because the patients themselves are in the driving seat with the experts. A world where European authorities come to the rescue of destabilised production chains to prevent shortages and organise European solidarity. A world that embraces progress by pushing the development of innovative treatments for unmet needs. A world that is resolutely committed to supporting the most vulnerable with a major European Rare Diseases Plan. This is the world is the one that emerges from the vote in committee vote and confirms our ambition to build a more resilient and healthier Europe.”