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Articles by Alexander Natz
Acting today, while building a stronger Rare Disease access and innovation ecosystem through partnerships
Europe’s rare disease debate is gaining momentum, but patient access remains patchy. The challenge is delivering real improvements now, not only after new reforms take years to take effect There is broad support from the innovative pharmaceutical industry to establish an EU Rare Disease Action Plan (EU RDAP). While the political agenda in the EU continues to shift between competing priorities, momentum behind this long-standing call is growing.
Navigating The Uncharted Waters Of EU HTA
Navigating The Uncharted Waters Of EU HTA 16 Dec 2024 • By Alexander Natz and Matias Olsen The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.
Navigating The Uncharted Waters Of EU HTA
Navigating The Uncharted Waters Of EU HTA 26 Nov 2024 • By Alexander Natz and Matias Olsen The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.
Why rare diseases must remain in the political spotlight
As a new political mandate kicks off for the EU Institutions, it is imperative that the political spotlight on rare diseases does not fade. The past 20 years have seen a considerable increase of activity at both political and non-political level. Almost all EU Member States developed or are developing Rare Disease Action Plans.
How the EU can strengthen pharmaceutical competitiveness
In its new mandate, the European Commission has highlighted competitiveness as a cornerstone of its agenda. This renewed focus is timely and essential, especially in light of the Enrico Letta report on the future of the European single market, published in April, and the recent Mario Draghi report on the future of European competitiveness.
Advancing innovation for rare disease patients: a call to action on Rare Disease Day 2024
This year we commemorate Rare Disease Day on the 29th February, the rarest of days. This globally coordinated movement aims to raise awareness about rare diseases and the impact they have on both the people living with them and their families. Rare Disease Day looks at the 36 million people in the EU who live with a rare disease1 to make sure, they are not overlooked.
A holistic, realistic approach to OMP reform and action
As was the case in 1999, the European Union currently finds itself at a pivotal juncture. The fate of the pharmaceutical sector and the rare disease ecosystem hangs in the balance, with significant implications for the future. Contributing to the development of over 230 orphan medicinal products (OMPs), the introduction of the OMP Regulation in 2000 brought stability and predictability for developers.
Looking out for the little guy: Why we need a competitive EU pharmaceutical framework for small and mid-sized companies
The revision of the general pharmaceutical legislation, Orphan Medicinal Products (OMP) and Paediatric Regulations presents a unique opportunity to build on the success of the existing rules and create a competitive and innovative healthcare ecosystem over the next two decades and beyond.
Learning should not end with school: rethinking entrepreneurship in Europe
With 2023 designated as the European Year of Skills by the European Commission, it is time for a rethink on how to approach lifelong learning and work in Europe. The changes that are taking place now, particularly in the area of artificial intelligence and automation, are likely to drastically alter the way many people work.
Making the EU Pharma Package Count for Smaller Companies
Alexander Natz of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) casts his eye over the potential effects of the upcoming EU Pharmaceutical Legislation for small- and medium-sized enterprises in Europe. Natz feels that Europe is at a crossroads in terms of its positioning as a driver of innovation and calls for inter-stakeholder collaboration to build a resilient EU pharmaceutical framework.
Thoughtful Calibration
Since its adoption, the Orphan Medicinal Products (OMP) Regulation greatly contributed to the development of orphan therapies, with over 200 drugs approved in the EU, improving the lives of the 6.3 million people living with rare diseases in Europe, their families, and carers. The legislation is an example of how a regulatory framework can foster and drive innovation and investments to address patients’ needs.
Launch Conditionality: What's at Stake?
Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and disproportionately burden market authorisation holders without meaningfully improving patient access.
What is Needed to Reinforce Biopharmaceutical Innovation in Europe?
The EU biopharmaceutical ecosystem is currently languishing in third place globally. EUCOPE’s Alexander Natz discusses how the European Commission’s most fundamental review of the pharmaceutical legislation in decades is supposed to change that but in reality, is discouraging innovation and competitiveness. The European Commission’s ambition to future-proof the EU legislative framework to tackle patient access issues is commendable but ripe with problems.
Opinion: New EU HTA Procedure -Will it Reduce the Complexity and Burdens for Manufacturers?
EUCOPE’s Secretary-General Dr. Alexander Natz sees both opportunities and pitfalls with the EU HTA procedure, saying that the next three years will decide the crucial steps and whether the new procedure leads to reduced burdens for developers and faster patient access to innovative therapies.
The Implications Of The New EU HTA Regulation For Companies
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Rare Diseases Day: How the French Presidency can change the rare disease landscape
Seizing Opportunities Philippe Berta, President of the rare diseases study group in the French Assembly, says the French Presidency of the EU is an opportunity to take advantage of future innovations With the development of personalised medicine, in the future, the challenges facing rare diseases today will be no more acute than those of the majority of diseases. Although rare diseases affect three million people in France, and 30 million people in Europe, they are divided into 7,000 pathologies.
Learning from the rare disease community
Europe’s pharmaceutical entrepreneurs are taking the lessons learned from this community to develop health innovation which would not have been dreamt of a few decades ago Adobe Stock By Alexander Natz Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) 25 Feb 2022 @EUCOPE Today, numerous health policy reforms and new initiatives are underway or about to launch in Europe – including proposals for revising EU rules on incentivising the...
Market Access Lessons For Cell And Gene Therapies In Germany
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