HTA Austria Austrian Institute für Health Technology Assessment
AIHTA
The AIHTA is an independent entity for scientific decision-support in the health sector.
ID: 325809433036-15
Lobbying Activity
Response to Revision of the variation framework for medicines
11 Sept 2023
We very much support the overhaul of the current pharmaceutical legislation in favor of innovation for the (Austrian) patients. AIHTA appreciates some propositions in the proposal and welcomes the direction of these, proving that the EC is willing to address the numerous market failures. Though increased transparency and the need for comparative evidence is acknowledged in the proposal, it is however - not going far enough for true changes. There should be no watering down of the direction of the new legislation. Public health is essential for European values: medicines must be available, accessable and affordable! Please see detailed comments in the attachment
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
19 Apr 2021
Vienna, April 2021
The Austrian Institute for Health Technology Assessment (AIHTA) welcomes the EC - initiative for the Roadmap and the establishment of a Pharmaceutical Strategy seeking to ensure availability and access to and affordability of pharmaceutical innovations in Europe. There is urgent need for actions for regulatory and policy interventions to enforce access, affordability and availability of essential and innovative drugs in Europe and not to further endanger the sustainability Europe´s solidarity-based health care systems.
AIHTA appreciates to be given the opportunity to comment and give feedback on the paper “Combined Evaluation Roadmap/ Inception Impact Assessment”: we fully endorse the aims and the key areas identi-fied where change is needed (p 2 of evaluation roadmap/inception impact assessment) and the elements for policy options (p 3 pp).
Nevertheless we would like to stress additional points somewhat covered but not explicitly expressed:
1. Supporting independent needs-driven R&D for the development of truly novel pharmaceuticals by identification of needs and milestone payments for their development in publicly funded trials (ex-ploration of incentives for public and/or public-private partnerships in the development of drugs).
2. Investing in platforms with open access to (publicly funded) knowledge (patents) and establishing a framework of conditions of open access to (with public resources generated) data and knowledge (cornerstones of minimum conditions such as availability and full transparency in price-setting) (de-velopment of legislative framework for the obligation to declare public funding for drug R&D and for corresponding binding conditions on affordable pricing).
3. Enforcing obligations for full transparency on the life-path of each drug seeking approval in Europe (e.g. full availability of information on basic research financing leading to patents and on early stag-es of drug development; of public support to biomed clusters and firms, of clinical trials and spon-sors, of the contribution of public hospitals to clinical trials, etc.) (development of legislative framework for the obligation of transparency for R&D costs).
4. Revising the orphan drug legislation and implementing instruments to penalize its undue exploita-tion and misuse (development of instruments to screen and penalize undue exploitation and misuse of the orphan drug legislation)
5. Strengthening the regulatory standards by raising the bar for approvals of medicines with require-ments for robust evidence such as comparative clinical trials with at least a minimum of follow-up time as well as efficacy standards (defined by important differences in individual indications) and ensure that accelerated approvals are exceptions and not the rule and follow-up with those ap-provals lacking robust evidence incl. consequences (market withdrawal) if evidence is not delivered (simplifying administrative elements of the legislation only, but not reducing the requirements for robust clinical evidence).
Read full responseResponse to Intellectual Property Action Plan
4 Aug 2020
The Austrian Institute for Health Technology Assessment (AIHTA) welcomes the EC - initiative for the Roadmap on the Intellectual Property Action Plan seeking to promote better licensing and deployment of IP and to pro-mote global fair play on the pharma market. The covid-19 crisis has brought some grave problems to the light and to the attention to a broader public.
The European Commission can play and should play an important role in re-regulating the Intellectual Property and limit market exclusivity by
1. Establishing a framework of conditions of open access to (with public resources generated) data and knowledge (patents).
2. Investing in platforms with open access to (publicly supported) knowledge (patents).
3. Providing legal support on those conditions to all publicly supported drugs (at any stage of the R&D).
4. Revising the orphan drug legislation and implementing instruments to penalize its undue exploitation and misuse.
5. Enforcing obligations for full transparency on the life-path of each drug seeking approval in Europe (e.g. full availability of information on basic research financing leading to patents and on early stages of drug development; of public support to biomed clusters and firms, of clinical trials and sponsors, of the contribution of public hospitals to clinical trials, etc.).
There is no need for more incentives for pharmaceuticals, monopolies (market exclusivity) should be avoided, since they hinder access for essential drugs for patients and cause high prices for governments and social in-surances. In contrast, the misuse of incentives (such as the orphan drug designation) should be penalized strictly. Healthy competition should be promoted.
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