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Europharm Small and Medium Size Companies

Europharm SMC

L’Association a pour objet, à l’exclusion de tout but lucratif, de développer la recherche scientifique et d’améliorer le bien-être du public en encourageant le développement scientifique et technologique des petites et moyennes entreprises pharmaceutiques des états membres de l’Union Européenne (UE) et de l’Association européenne de libre-échange (AELE) et en renforçant leur compétitivité.

Lobbying Activity

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Europharm is the European Association representing Medium Sized Pharmaceuticals companies in the EU. Europharm fully supports the Commission’s ‘targeted approach’ in this revision as it serves the purpose to enhance regulatory simplification and efficiency. This approach could be most efficiently pursued on the basis of the existing legal acts, i.e. maintaining both, Directive 2001/83/EC and Regulation (EC) No 726/2004, amending them where necessary. The current dual marketing authorisation system consisting of the Directive for decentralised/national procedures and the Regulation for the centralised procedure should be maintained throughout the revision process. It secures the suitable allocation of tasks to the respective competent authorities and eliminates competition hurdles especially for SMEs. The Directive remains the suitable and preferable legal act to regulate the national/decentralised authorisation procedures for marketing authorisations issued by national competent authorities. For SMEs which have mostly national based Marketing Authorisations, it is especially important to continue to interact with their national regulatory authority. Furthermore, Europharm calls for for a, EU Wide, regulatory harmonization, focusing on flexibilisation, streamlining and simplification of regulatory procedures whenever feasible. Revision on current pharmaceutical legislation should maintain or simplify procedures for the regulatory system pertaining to the well-established, off-patent products already existing on the market, allowing for regulatory stability and securing SME competitiveness on these products. The overall idea would be to rely more on the Industry’s compliance to rules and regulation and increase the authorities’ surveillance and inspectorate activity. Thus, Europharm supports the introduction of regulatory flexibility measures and a bigger reliance on QPs’ decisions by empowering them with more discretionary power to decide on a risk-based approach on GMP and GDP variations/matters. In summary Europharm calls for a more simplified, risk-based, Post-approval regulatory framework. Europharm advocates the principle of proportionality when designing new legislation In many cases the implementation of new Directives impacts the competitiveness of SMEs due to the substantial (possibly disproportional) investments required for the respective implementation, especially for companies with a very low turnover or operating in just one market. The implementation of the Falsified Medicines Directives is a good example of a disproportional impact and burden experienced by many small companies to a point that obliged some products to be withdrawn from the market on the grounds of economic reasons. Europharm therefore, appeals for the reassurance of the principle of proportionality when drafting new legislation, focusing specifically on the human and economic resources associated with the implementation of such new regulation. In these situations, SMEs, would recommend that costs of implementation should be proportional to the size of the company or alternatively be financially supported. These costs shouldn’t be an obstacle to implementation of new regulations and shouldn’t limit SMEs’ development and competitiveness. Europharm is also concerned on signs of reduced Competitiveness of SMEs in Europe. Whilst recognising that healthy competitiveness drives innovation and in turn leads to the of breakthrough medicinal products for rare diseases and/or unmet medicinal needs such as those for innovative antiinfectives or preventive solutions for pandemic threats, thought should be given to the system by which incentives are granted to SMEs for pursueing innovation and protecting their IP, thus encouraging research and development in these highly economic risk fields. Europharm’s position is described and explained more in depth in the position paper attached.
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Response to European Health Emergency Response Authority

20 Feb 2021

Abstract Europharm SMC Position Paper Europharm SMC is the official European Association representing Small and Medium Sized pharmaceutical companies in the EU. Europharm SMC supports and defends the interests of its members, in achieving a legal and political framework compatible with the interest of SMEs in the global pharmaceutical industry. Under the current circumstances and particularly due to the economic consequences of the pandemic, SMEs are the most vulnerable companies, and therefore, further active measures need to take place to support SMEs with financial and regulatory measures to ensure economic survival and support of SMEs in all stages of medicines' development, and in the manufacturing and distribution activities. Europharm’s proposal for enhancing SMEs’ competitiveness and viability 1) Ensure the profitability of SMEs and strengthen the competitiveness of European SMEs a) Stimulate new business synergies, support and promote international expansion of SMEs to other EU countries and ROW. Even if the global EU Pharmaceutical trade balance shows a positive value of 122,031 Mio€, this value could be greater and there are many EU countries showing a negative balance and this should be improved. Europharm’s proposals are: - Create incentives and special guidance from regulatory authorities for registration preparedness and submission and other investments made for expansion of local activity to other markets and/or export of their products - Cooperate with associations which promote and enhance business partnerships and collaborations among SMEs and with other companies. b) Economical sustainability of mature and essential products To promote the discussion on how to achieve smart spending and guarantee the economical sustainability of SME’s, Europharm brings forward some ideas for European policymakers: • Secure existing European production capacities by ensuring price stability for medicines whose active substances are produced in Europe; • Determine the drugs whose sustainability of local supply is no longer ensured for economic reasons and find ways to restore it; • An origin criteria could be introduced in hospital tenders in addition to the price criteria in order to support EU production and to stimulate the creation of local high value jobs. • Better coordination among EU countries to ensure that pricing decisions taken by one country do not lead to domino effect in other countries with negative impacts on patient access to medicines and on company economical sustainability. c) EU economic policy and financial incentives for EU MAHs sourcing finished products and/or APIs from European manufacturers This could be achieved for example: - With a change in the pricing mechanisms in Europe which should ensure an acceptable price level and stability to guarantee long-term viability of the production and distribution in the European territory. - With the development of an exceptional deduction on productive investments to be able to modernize and keep existing industrial sites competitive, - With exemption from property tax and contribution on the added value of companies for a period of five years, for their production and storage sites, - With a temporary reduction at least for 3 years, on the tax on the turnover of the finished product 2) Secure supplies of essential drugs and reduce the risk of shortages 3) Regulatory procedures simplification & administrative assistance a) EU Wide regulatory harmonization, flexibilization and simplification of regulation b) Apply the principle of proportionality 4) Research and Development and Incremental Innovation a) Accelerate the possibilities of repositioning certain molecules b) Guidance and assistance on regulatory issues and scientific advice at an early stage of R&D. c) To simplify and facilitate access to EU funding programs
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