European Biopharmaceutical Enterprises
EBE
The mission of “European Biopharmaceutical Enterprises” (EBE) is to: Represent biopharmaceutical companies of all sizes operating in Europe in the formulation of policies at global and European levels. Focus on enhancing emerging healthcare technologies and promoting science innovation in Europe via expertise in: • Innovation eco-system and funding models • Emerging biotech & science - regulatory advancement and advocacy Contribute industry expertise to the development of new regulatory frameworks, guidelines and standards of relevance to biopharmaceuticals. Promote the exchange of good practices to foster the development of safe, efficacious and high-quality medicines. Increase awareness of the sector, its products and the tangible benefits that biopharmaceuticals bring to patients and society worldwide. Support the business development of member companies, especially SMEs, through advice, networking, training and educational opportunities. Facilitate in (...)
ID: 768792210017-73
Lobbying Activity
Response to Revision of the EU SME Definition
6 Jul 2017
We welcome the Commission’s initiative to review whether the EU SME definition should be adapted. Representing SMEs in the biotech and pharmaceutical sector we believe that a revision should not be limited to adapting balance sheet totals or turnover to inflation, or stop-gapping loopholes for companies that in practice are not typical SMEs. We note the Commission’s stated objective of aiming “to ensure that sector-specific particularities are sufficiently considered when identifying SMEs”. While acknowledging the benefit from defining SMEs, and the simplicity of a common SME definition, we believe that some sectors are sufficiently different to warrant a sector-specific approach. We would like to offer some considerations for the biotech/pharmaceutical sector. This sector, unlike many others, requires high-risk high-volume investments over long periods of time. This may result in a higher number of employees in R&D, as well as in balance sheet totals above the current thresholds (at least temporarily), in combination with rare but then high one-time revenues (e.g. upfront payments / milestones). Specific challenges that our members encounter, relate to the following aspects.
Linked/Partner companies:
We fully appreciate the need for rules to exclude smaller affiliates of big trusts from being considered SMEs. However, we recommend that the Commission consider distinguishing between fully integrated groups or trusts and other situations, where one or two major investors may provide majority funding for companies that by all other criteria are SMEs and that are not integrated with or controlled by the majority funders. There are private risk-equity investors boosting SMEs in particular in the biotech/pharmaceutical sector, whose investment is discriminated against under the current rules. For example, in Germany two family-owned offices (Hopp and Strüngmann) each have invested about 1 bn € in a number of biotech companies, holding in most cases > 25% and in many cases >50% of the respective biotech company. According to the current definition most, if not all of these companies – which are clearly SMEs based on the environment they operate in – are not considered SMEs due to the Partner/Linked Enterprise rules. Current rules define some important exceptions (e.g. for venture capital funds, institutional investors, universities or small autonomous local authorities) but not private risk-equity, which is thus clearly disadvantaged. Business Angels are listed as an exception but limited to 1.25 m€. Another potential approach to allow exceptions to the current partner/linked enterprises rule could be to consider how far from market access a company/project is; e.g. 5 years or more from market. Those are instances where investors may be less willing to invest into exploratory R&D.
Turnover:
We advocate for a sector specific approach and suggest that the Commission consider applying learnings from rules that deviate from the current EU definition, but which are applied in programs officially supported by the Commission. This may again need to be done in a sector-specific approach. An example would be the public-private partnership “Innovative Medicines Initiative”. Under the IMI 2 programme mid-sized companies are eligible for funding when they meet the following:
• have an annual turnover of €500 million or less;
• not be affiliated entities of companies with an annual turnover of more than €500 million.
Lastly, the Commission could consider harmonising with other world regions, e.g. US SBIR/STTR rules, which define sector-specific thresholds. Pharmaceutical or biotech companies with many more that the EU numbers of employees are eligible to receive grants or awards. The limit for Pharmaceutical Preparation Manufacturing and Biological Product (except Diagnostic) Manufacturing is 1.250 employees, significantly above the standard size of 500 employees for most other sectors, and significantly above the EU threshold.
Read full responseResponse to REACH Regulation - Annex XIV
14 Oct 2016
The European Biopharmaceutical Enterprises (EBE) represent the voice of the biopharmaceutical industry in Europe, and counts 59 biopharmaceutical companies of all sizes as members, 60% being small to mid-size, plus 1 association with 320 member companies. We limit our comments to 4-tert-octylphenol ethoxylates, one of which is Triton X-100, which is referenced hereafter.
Patient Safety: Triton X-100 is a critical material used for viral inactivation of biotechnological medicinal products to ensure patient safety. The risk of viral contamination is common to all medicines derived from mammalian cell lines or plasma. Triton X-100 is considered the most widely used and robust pathogen inactivation technology known today. The impact to public health of a time-limited authorisation for Triton-X-100 could be significant, given the challenge of new and evolving viruses. Triton X-100 offers a broad range specificity to inactivate such viruses.
Additional Regulatory Burden: Where technically feasible, our members strive to replace hazardous substances with less hazardous alternatives. However, replacing Triton X-100 in a well-defined biomanufacturing process once a medicine is in the first-in-human clinical trial phase of development is extremely difficult. It likely requires additional clinical trials and animal testing to prove equivalent efficacy and safety, adding to the already long development duration and regulatory burden. Assuming an alternative is found, amendments to Marketing Authorisations previously assessed and approved by EU authorities would be required, including additional manufacturing facility validations. The additional regulatory burden is likely to lead manufacturers to source their medicines outside the EU, placing pressure on supply chains of critical medicines.
Sudden Loss of Supply: The life sciences sector accounts for <10% of 4-tert-octylphenol ethoxylates used in the EU. Placing 4-tert-octylphenol ethoxylates in Annex XIV could lead to a sudden loss of supply of this critical raw material. This would have significant consequences on the supply chain of medicines that use Triton X-100 for viral inactivation.
Impact on Future Investment: The unpredictability of REACH Authorisation timelines and the availability of manufacturing capacity outside EU, where REACH does not apply, are disincentives to long-term investment in EU manufacturing facilities. Driving investment to facilities outside EU will result in less investment within the EU, which over time will have dramatic consequences for EU facilities. Uncertainty and unpredictability relating to Triton X-100 will continue until its proposed sunset date of late 2020.
Environmental controls in place: Environmental controls are already in place for 4-tert-octylphenol, the substance of concern, through other EU instruments, e.g. the Directive on Environmental Quality Standards (Directive 2008/105/EC).
In recital 18 of the draft amending regulation we note the call for long review periods in instances where there is no suitable alternative, when the risks posed by the use are limited by appropriate and effective risk management measures, and when the benefits arising from the use are expected to be high, such as for medicines and medical devices. We consider this to be the case for 4-tert-octylphenol ethoxylates. Nevertheless, the authorisation process under REACH will generate regulatory uncertainty for our industry regarding availability of critical raw materials, such as Triton X-100, and does not address the long investment cycles required to bring our medicines to patients.
We request that a Patient Safety Impact Assessment is conducted ahead of any REACH Committee consideration to place Triton X-100 on Annex XIV, and that other options to achieve the aims of REACH while protecting patient safety and maintaining the competitiveness of our industry, including exempting Triton X-100, be considered.
Read full responseMeeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)
22 Jun 2016 · Advanced therapy medicinal products