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European Coalition on Homeopathic and Anthroposophic Medicinal Products

ECHAMP

Mission: To enable our members to meet the demand from users and prescribers across the EU for homeopathic and anthroposophic medicinal products.

Lobbying Activity

Response to Revision of the variation framework for medicines

28 Feb 2024

ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, welcomes the consultation on the draft Delegated Regulation on Variations. We are aware that this revision of the Commission regulation (EC) No.1234/2008 is a strictly targeted one. The second phase of review being developed after the adoption of the revised EU Pharmaceutical legislation. We applaud the proposals to decrease the administrative burden. However, we ask the Commission to include the maximum flexibility feasible in these proposed initiatives. In particular, we refer to the principle of downgrading for variations that have no impact on quality, safety, and efficacy if justified by the Marketing Authorization Holder on a risk-based approach or where a particular condition (introduced in the variation classification) is met. Moreover, we recommend that, for the notification procedure for minor variations of type IA, both the possibility of notifying immediately and the possibility of reporting annually should be kept in order to avoid practical implementation problems. We look forward to the next stage of the review and we hope that the Commission will take full consideration of the input provided by ECHAMP in its response submitted in September 2023 to the initial public consultation, for its proposal.
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Response to Evaluation and revision of the general pharmaceutical legislation

23 Oct 2023

ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, represents an EU-based industry that has been serving the European market for decades. EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States; the EU being the global centre of expertise in manufacturing, quality standards and regulation of this industry. ECHAMP supports the proposal with its focus on provisions relevant to achieving the specific objectives of the review. We welcome the Commissions proposal to maintain the dual legal format of Regulation and Directive, in line with the current legislation that is built on a system of both national and European marketing authorisations. With regard to the proposed provisions for the monitoring and management of shortages and critical shortages, we recommend a proportionate and pragmatic approach: the provisions should be aimed at medicinal products on the lists of critical medicines, so as to avoid generating an unintended and purposeless administrative burden for both marketing authorization holders and competent authorities.
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Response to Evaluation and revision of the general pharmaceutical legislation

23 Oct 2023

ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, represents an EU-based industry that has been serving the European market for decades. EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States; the EU being the global centre of expertise in manufacturing, quality standards and regulation of this industry. Homeopathic products are used in 100 countries around the world, the third most popular specific complementary medicine. ECHAMP supports the Commission proposal with its focus on provisions relevant to achieving the specific objectives of the review. We welcome the Commissions proposal to maintain the dual legal format of Regulation and Directive, in line with the current legislation that is built on a system of both national and European marketing authorisations. This dual framework will continue to facilitate the needs of patients using homeopathic medicinal products, balancing the quality and safety of these products while ensuring citizens have access to the medicines they require. Awareness of homeopathy is high and the use of homeopathic medicines is widespread in the EU 79% of French, 60% of Germans, 57% of Italians and 47% of Spanish have used homeopathic medicines in their lifetime. Research confirms significant added value to society, including clinical effectiveness, low incidence of side effects and cost-effectiveness. In addition, these long-established therapies and their medicinal products have a role to play in fields of specific relevance to EU health policy. These products offer valuable integrative healthcare treatment options in areas such as polypharmacy, non-communicable diseases, healthy ageing and for children and young adults. ECHAMP also welcomes the Commissions proposal to preserve the existing provisions for homeopathic medicinal products without changing their substance, as stated in preamble 4 of the draft Directive. This remains in line with previous efforts on harmonization as expressed in the relevant preambles of Directive 2001/83/EC and applicable standards as set down in the European and national pharmacopoeias. To ensure that the scope of the provisions referred to in preamble 4 is comprehensive, we ask the Commission to confirm that the medicinal product category referred to in preamble 22 of Directive 2001/83/EC (namely, anthroposophic medicinal products described in an official pharmacopeia and prepared by a homeopathic method) is also covered by preamble 4 so that the intent of these provisions is unambiguously carried forward, acknowledging their long-standing European tradition. As data driven healthcare opens up immense potential for improved health situations, we recommend the use of broad definitions of data sources concerning real world data and real world evidence to inform decisions on medicines so as to ensure maximum inclusion of patient experience. We fully agree that environmental risks are associated with pharmaceuticals and environmental risk assessment and mitigation are important. We highly recommend close collaboration with the industry in order to leverage all available data to assist with prioritization avoiding duplication of work and ensuring proportionality.
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Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

ECHAMP, the European Coalition on Homeopathic & Anthroposophic Medicinal Products, represents the majority of the companies active in the production and distribution of those products in the EU. We endorse the rights of more than 110 million patients and consumers in the EU to have easy and comprehensive access to reliable homeopathic and anthroposophic medicinal products which meet the highest standards of quality, safety and effectiveness. The EU is the global centre of expertise in manufacturing, quality standards and regulation of this industry, which has been serving the European market for decades. Homeopathic and anthroposophic products have a solid, long-standing legal framework in European pharmaceutical legislation. ECHAMP understands and fully supports the need to develop a stronger EU health union in which the EU pharmaceuticals system can adapt to a changing competitive global environment. We also support the ‘targeted approach’ pursued by the Commission for the revision of the pharmaceutical legislation. We welcome and appreciate the Commission’s chosen consultation process of combining a mix of public and targeted consultations and ensuring a broad stakeholder input into the assessment of the impact of any changes. The revision of the pharmaceutical legislation should result in a stable and flexible regulatory environment for both new and innovative medicines and for existing medicines. Existing medicines form the backbone of our medical systems and guarantee routine care for the daily needs of patients. A stable environment guarantees access to these products, thereby also contributing to the resilience of Members States’ health systems. While moving towards a stronger unification in the area of health, it is imperative that none of the ‘established’ products are lost. Access to these medicines should not be negatively or indirectly affected by the proposed changes. Regulatory improvements in the case, for example, of the application of digital technologies or the simplification of the system for variations, should, where relevant, be beneficial for all medicinal products, irrespective of their nature. We stress the need to ensure through this process that the strong fundament that has been created by the existing EU dual legislative framework of Directive and Regulation is retained. This will result in an inclusive system, which both facilitates innovation and fully exploits the potential of existing products, in a regulatory frame that continues to respect national competence and national traditions in order to deliver the best heath care for each EU citizen. The maintenance of the current structure fits best to the Commission’s targeted approach. The promise of a truly holistic, patient-centred, forward-looking EU pharmaceutical strategy must be fully reflected in the design of any future legislation so as to accommodate both the rich array of medicinal products – prescription and OTC – which are already available to the EU patient today, and new innovative medicines.
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Response to A European Health Data Space

28 Jan 2021

ECHAMP welcomes and supports this important initiative, which will be an essential cornerstone for the Pharmaceutical Strategy. We are pleased to see that the proposal emphasizes the importance of allowing patients and citizens control over their own health data and of exploring how to facilitate the inclusion of citizen-generated data. The further digitalisation of the healthcare sector will benefit all stakeholders by facilitating and enhancing appropriate research and innovation. Better access to health data will allow researchers and policy makers to understand the real use of and actual demand for different treatments and health services and to adapt policies and strategies accordingly. It is therefore important that the information gathered relates to both new and established treatments and medicinal products. Traditional and complementary medicine is an important part of the health system in many countries and has an increasingly significant role to play alongside conventional medicine both in preventive strategies and in the treatment of disease to improve health outcomes (integrative approach). An accumulation of data on real world use of these treatments and medicines will allow their full potential to be explored and exploited, so as to maximise their contribution to reducing any unnecessary burden on health systems at a time when resources are already stretched. A truly holistic, patient-centred, fit-for-purpose Pharmaceutical Strategy will combine the best of the established therapies with the new. The conscious integration of pluralism into the EU health and care system will ensure that patients and health professionals have access to a wide choice of reliable, high-quality medicinal products, including homeopathic and anthroposophic medicines. These elements need to be fully integrated into the development of an optimal health data space. For example, our experience in accompanying the EMA, ISO IDMP substance, product, organisation and referential (SPOR) task force in the development of SPOR data management services has shown us how essential it is to ensure that all medicinal product types and all treatment options are included from the outset in the development of any relevant database. Standards developed need to allow for the specificities of each family of medicinal products to maximize the availability of data that can be used to facilitate and support patients with a broad choice of medicinal products. We look forward to contributing to the on-line consultation from the perspective of integrative medicine.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

1 Jul 2020

ECHAMP fully supports this initiative. We recommend that the new strategy also acknowledges the contribution that the industry for homeopathic and anthroposophic medicinal products can make towards achieving a forward-looking EU Pharmaceutical Strategy that balances curative treatments with preventive care, including appropriate self-medication. Homeopathy is the third most popular specific complementary medicine, used in 100 countries globally (WHO); homeopathic medicinal products have long-standing use in most EU Member States and have been widely used in primary and clinical care across Europe for decades. More than one in five Europeans use homeopathy for their health care. 70% of users experience improvements in their health, choosing these medicines because of their safety profile. The growing use of homeopathic medicines is consistent with the trend towards integrative health care; they also offer a solution for self-management of minor health conditions, in line with the trend towards self-care. In its report on access to medicines (2018/C 263/02), the European Parliament demands that patients ‘have access to the healthcare and treatment options of their choice… including complementary and alternative therapies and medicines’. EU citizens expect to benefit from equal access to safe therapies, both new and established. Homeopathic medicinal products have a long-standing, solid legal framework in European pharmaceutical legislation, supported by high quality standards as defined in the European Pharmacopoeia. The current regulatory framework serves the patients’ needs in this area, striking a balance between ensuring the quality and safety of these products, while at the same time giving citizens access to the medicines of their choice. Traditional and complementary medicine is described by WHO as ‘an important and often underestimated health resource’. Homeopathic medicinal products have a role to play in the face of major health challenges and the rising burden of diseases in the EU. They offer valuable treatment options in support of EU health policy goals on multimorbidity, polypharmacy, chronic diseases and an ageing population. They can contribute to safe and effective strategies to reduce the use of antibiotics. A growing body of scientific research, including published clinical studies, demonstrates the effectiveness of these forms of treatment. Traditional and complementary medicine has a valuable role to play alongside conventional medicine systems in tackling the unique health challenges that Europe is now facing. The full potential of traditional and complementary medicine must be explored and exploited, reducing any unnecessary burden on health systems at a time when resources are already stretched. In this context, these medicinal products offer cost-effective options that contribute to the financial sustainability of healthcare systems. A future strategy for real world data will help to improve understanding of treatment outcomes for existing complementary products, leading to better decisions on the role they can play in meeting patients’ needs. This is an EU-based industry that has been serving the European market for decades and the EU is the global centre of expertise in manufacturing, quality standards and regulation of this industry. The products have a negligible impact on the environment, due to low intrinsic toxicity of the majority of the substances processed. Many manufacturers promote organic farming for their source materials, fostering biodiversity and optimising the use of natural resources throughout their supply chain. A truly holistic, patient-centred, forward-looking Pharmaceutical Strategy will combine the best of the established therapies with the new, through the conscious integration of pluralism into the EU healthcare system, ensuring that patients and health professionals have access to a wide choice of reliable, high-quality medicinal products, including homeopathic medicines.
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Response to Revision of EMA fees

16 Oct 2019

ECHAMP welcomes this consultation and we are pleased that possible misalignment of some fees with the underlying costs will be addressed. We fully support the objective of ensuring a fair distribution of fees. We ask for your specific attention for the category of homeopathic medicinal products. We would like to refer to the ECHAMP response (attached) to the public consultation conducted in 2012 regarding pharmacovigilance fees. Fees should in large correspond to the service/ activity provided, this is not the case for homeopathic medicinal products in the area of pharmacovigilance. We urge you to take this in to consideration in your further evaluation.
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Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

17 Oct 2016 · Homeopathic medicines

Meeting with Vytenis Andriukaitis (Commissioner) and

9 Jul 2015 · Regulatory Framework for Homeopathic/anthroposophic medicines