KWF Kankerbestrijding
KWF
KWF is tegen kanker.
ID: 193588825276-25
Lobbying Activity
Meeting with Annie Schreijer-Pierik (Member of the European Parliament)
11 Oct 2022 · Combatting cancer
Response to Evaluation and revision of the general pharmaceutical legislation
22 Apr 2021
The European Fair Pricing Network (EFPN) welcomes the Commission’s initiative to revise the EU general pharmaceutical legislation. The EFPN urges the Commission to prioritize the following problems:
First, unequal access to affordable medicines for patients EU wide is a great problem that threatens the health and lives of many Europeans. The EFPN strongly agrees with the Commission that marketing strategies which limit access should be tackled.
The lack of transparency in pricing and prices of medicines and treatments throughout the EU is another important factor contributing to high prices of medicines and limited access. Legislation should, where possible, guarantee a minimal level of transparency and facilitate cooperation between Member States to achieve affordable treatments with real benefit for patients.
Finally, on the issues of unequal access to affordable medicines, the EFPN would like the pharmaceutical legislation to also take into account the (marketing) tactic that involves the withdrawal of off-patent drugs with the intention to reintroduce with a new indication and much higher price. The EFPN urges to keep this problem in mind in the current revision. Withdrawals of medicines that cover significant patient needs, but are withdrawn for pricing reasons (being too cheap), must be addressed. We strongly agree with the Commission’s earlier statement on the Aspen-case; companies should not misuse their “dominant position to increase prices”.
The EFPN appreciates the Commission’s suggestion on medicines for children and rare diseases to “address issues related to availability and access to medicines, improved rules linking the reward with the placing on the market of the products in most/all Member states will be explored.” The EFPN is of the opinion that such linkage, and others like for example linking public financial support for drug research and development to affordability of medicines, would highly increase access to medicines for patients in the EU, and recommends to explore a similar approach when it comes to the general pharmaceutical legislation.
In the context of unmet medical needs, the EFPN agrees with the recommendation put forward by EORTC in their submission to the revision of this legislation, and with earlier feedback provided by the Netherlands and Belgium regarding the IIA on medicines for children and rare disease. A clear and common understanding of what unmet medical needs are is needed. An unambiguous definition requires in our view transparent criteria to be set by a multi-stakeholder process, which includes regulators, academia, independent patient organisation, and other relevant actors. The EFPN suggest the Commission, in the process of defining unmet needs, to take the following issues into account: the public health priorities, the profile of the drugs and their impact on public resources.
The EU faces a big problem of inequity. This is a key challenge. There exists too big of a difference between and within Member States when it comes to access to medicines. In some Member States certain treatments are delayed or do no enter the market at all. Industry pricing policy’s play an important role in this issue. We urge the Commission to include the above mentioned issues in the framework of the revision. The EFPN stands by to assist the Commission on these and other issues.
The European Fair Pricing Network (EFPN) aims to secure fairer prices of cancer medicines while upkeeping the innovation pipeline and timely access for patients to promising new medicines. The Network collects and analyse reliable European data needed to measure challenges in the current pharmaceutical markets, and to develop new ways of organising innovation and sustainable supply of effective medicines.
https://www.efpn.eu/
Read full responseResponse to Revision of the EU legislation on medicines for children and rare diseases
15 Dec 2020
European Fair Pricing Network - EFPN
The European Fair Pricing Network (EFPN) welcomes the Commission’s initiative to seek a new legal framework to solve issues within current legislation on medicines for children and rare diseases. The EFPN urges the Commission to prioritise the following problems:
First, there are no approved treatments for 95% of rare diseases. This must change. Therefore, the EFPN strongly agrees with the Commission that medicines should be developed in areas of unmet medical needs. To ensure its target of encouraging real innovation in areas with high unmet medical need, public and private investment in R&D should be steered towards clearly defined public health needs. This should include medicines for children and rare diseases. To achieve this, an improved coordination and priority-setting mechanism is needed on a European, or even on a global, level. The new legislative framework should provide incentives to stimulate developments for patients with so-called ultra-rare diseases. Such incentives must reasonably reward the level of novelty of a product. Simultaneously, it should deter inappropriate use for so-called “artificially rare diseases” and multiplication of exclusivities in all forms.
The EU faces a big problem of inequity. There exists too big of a difference between and within Member States when it comes to access to medicines. In some Member States certain treatments are delayed or do no enter the market at all. Children and patients with rare diseases must have equitable access to affordable treatment. It should not matter where you live. More transparency in pricing and prices of treatments throughout the EU is urgently needed. The regulation should guarantee a minimal level of transparency and facilitate cooperation between Member States to achieve affordable treatments with real benefit for patients.
A problem that is linked to accessibility is the fact that there is no obligation for providers to introduce new orphan treatments in the entire European market. The EFPN sees a problem with the lack of legal conditions connected to incentives (e.g. SPC’s) that could enhance wide market availability. The fact that the Commission cannot reassess a provided designation on its effect for availability, affordability and accessibility might lead to problems connected to misuse of the regulation. To conclude: it lacks an intervening tool that keeps the paediatric and orphan pipeline healthy.
In addition, academia plays a vital role in developing treatments in the area of unmet medical need. The new legislative framework must value their efforts and ensure a level playing field for academic sponsors. Therefore, the regulations must extra support academic sponsors. To ensure that the pool of non -commercial sponsors enlarges, and thereby more new treatments for children and patients with rare diseases are developed.
Finally, the EFPN urges the Commission to promote and ensure transparency in its new legal framework for medicines for children and rare diseases. The EFPN believes that only through a transparent system starting from research and development all the way to manufacturing, marketing, trade and financing, can we ensure timely access to high-quality cost-effective treatments. Subsequently, there must be absolute transparency in who receives or is denied an incentive and on what grounds. The EFPN wishes to contribute to this stakeholder wide discussion on the matters as described above. If it would be the Commission’s preference, the European Fair Pricing Network welcomes any further dialogue.
We also endorse the position of the ECL. Here attached. Please see p.15-17
Read full responseResponse to Pharmaceutical Strategy - Timely patient access to affordable medicines
30 Jun 2020
Input by the European Fair Pricing Network
The European Fair Pricing Network (EFPN) welcomes the initiative by the European Commission to develop a new Pharmaceutical Strategy as a potential important step towards improving the functioning and transparency of the current pharmaceutical system.
We strongly agree with the EC’s recognition of the importance of a patient centric approach, securing sustainable access and assuring the availability of affordable medicines in the EU. To enable improved patient access to high quality treatments while securing the sustainability of health systems, the ambitious span in the Strategy, dealing with the entire life -cycle of pharmaceutical products sector, is both applaudable and necessary.
Particularly, we would like to stress the importance of transparency throughout the medicines pathway. We believe that increased transparency is a prerequisite to achieve the Strategy’s goal. In a broader sense, a non-transparent pharmaceutical system conflicts with principles of good governance, hinders patient participation, and decreases its accountability and undermines trust in related decision-making. We would like to argue that transparency is an essential condition to tackle the problems outlined in the Roadmap:
Unequal access to medicines that are not always affordable for patients and for national health systems across the EU
The high prices of medicines are, as the Roadmap rightfully claims, related to the general lack of transparency in the sector. This includes, but is not limited to, insufficient sharing of ex-manufacture prices, wholesale prices, rebates, R&D costs, public investments (including charity funding) between and within Member States. Confidential pricing agreements mask market pricing structures and unreasonable price differences between Member States.
Shortages of medicines
More information throughout the medicine supply chain is needed to detect, compare and prevent medicines shortages. Increased transparency and reporting obligations enable policy makers to distinguish incidents from trends to create adequate policy measures.
Innovation efforts are not always aligned to public health and patients’ needs
Transparency and knowledge of patient needs and preferences are essential in order to identify unmet medical need throughout Europe.
Technological and scientific developments may challenge the regulatory framework and consequently lead to unintended barriers to needs-driven innovation
The availability and quality of data, for example R&D data and open publication of full clinical study reports, is important to enable further research and appropriate use of medicines. In addition, the Clinical Trial Regulation (536/2014) also specifically obliges the need to be transparent and demands co-operation between and within Member States.
Increasing transparency throughout the pharmaceutical system should thus be approached as a separate objective, to enables achieving the formulated objectives in the Roadmap.
Increasing transparency should be achieved through:
I. Legislative measures, e.g., by re-opening and strengthening the transparency directive and the orphan directive;
II. Implementing and Designing adaptive legal frameworks that enhances RWE an data collection on safety and efficacy,
III. Enhanced and connecting Member State co-operation and collaboration, e.g., through regional initiatives such as Beneluxa and the Valletta Declaration; encouraging
Member States to share data on the real costs of treatments,
IV. Incentivising studies focusing on getting the patient and public health perspectives on unmet medical needs, and
V. The mission on Cancer should support projects aiming at transparency and fair pricing.
Importantly, the EU should ensure a safe and protected environment for transparency initiatives.
We look forward to work with the Commission and others to define and overcome the major challenges with improving transparency throughout the medicines journey
Read full responseMeeting with Vytenis Andriukaitis (Commissioner) and
5 Jun 2018 · HTA