Building policy consistency and predictable rules for all biotech sectors

Major developments

Looking for coherence between agriculture and industrial policy to support the bio-based economy

EU industrial policy strongly supports the emergence of a Knowledge Based Bio-Economy (KBBE), which will require new sources and mobilisation of renewable raw materials. At the same time the Common Agricultural Policy pushes towards lower production. EuropaBio argues for a more coherent approach between agricultural and industrial policy.

EuropaBio's Secretary General Willy De Greef pushed for policy coherence to support innovation and a bio-based economy on the BBC.

'Renewable Energy' Directive passed - speeding up the development and commercialisation of second generation biofuels

After almost one year of legislative work, the European Parliament and the European Council approved the Climate Action and Renewable Energy Package in December 2008. This includes a mandatory 10% target for transportation fuels coming from renewable energies - such as biofuel - by 2020. The proposed two-step approach (35-50%) for the greenhouse gas (GHG) emission savings threshold, together with incentives for second-generation biofuels will drive public support and increase private-sector investment in research and development to speed up the development and commercialisation of second-generation or advanced biofuels.

Pharma Forum - EuropaBio is helping to shape a single market for pharmaceuticals

In December 2008, the long-awaited Pharma Package, the content of which was heavily inspired by the work undertaken in the High Level Pharmaceutical Forum, was released. European Commission Vice President Günter Verheugen said this package would help "restore the EU's traditional role as the pharmacy of the world" and called for "safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector". EuropaBio is now working to ensure the three proposals on Information to Patients, Counterfeiting and Pharmacovigilance respectively are implemented with due consideration for biotech specificities.

Fighting for a coherent policy on ag biotech

An important part of EuropaBio's priority actions is to raise the awareness of the role of ag biotech as one of the tools contributing to sustainable development.

Within this context, EuropaBio is highlighting the importance of a supportive ag biotech policy not only to strengthen the competitiveness of the European agro-food sector, but also to create a sustainable European agricultural base in order to ensure the required source of raw materials that will be necessary to support the "bio-based economy" promoted by the Union. EuropaBio is also asking for coherence of policies through the approval process. Such coherence would result in the proper implementation of existing legislation on the approval of ag biotech products without undue delays in the approval process nor unscientific national or regional bans or unworkable coexistence measures on cultivation.

EPAA: as laboratory animal directive is reviewed, EuropaBio calls for a reduction of bureaucracy placed on SMEs

EuropaBio is a member of the European Partnership for Alternative Approaches to Animal Testing (EPAA), a joint initiative from the European Commission and a number of companies and trade federations active in various industrial sectors. The focus at EPAA is on mapping existing research, developing new alternative approaches and strategies, and promoting communication, education, validation and acceptance of alternative approaches.

In November 2008, a review of the laboratory animal protection Directive (Directive 86/609) was announced.

EuropaBio acknowledges the need for review of the laboratory animal protection Directive and fully supports the efforts to bring down the number of animals used, but at the same time calls for a reduction of the bureaucratic burden the Directive will place on SMEs, without any tangible benefits for animal health.

Together with the European Commission, EuropaBio has led the discussion on the development of industrial biotech in the new Member States and Associated Countries

During 2008, EuropaBio organised nine roundtables on industrial biotechnology as part of the FP6 project White Biotech TP in the new Member States and associated countries (Turkey and Croatia). The main purpose of these roundtables was to discuss the development of the bio-based economy through research and innovation programmes and via policy support, to identify how industrial biotechnology could be further developed, and how implementation and coordination could be improved between the new Member States and the EU. For presentations, summaries as well as a global analysis of the roundtables click here.

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Challenges and opportunities

Implementation of the Lead Market Initiative for bio-based products

EuropaBio's Industrial Biotechnology Council has developed a "European Policy Agenda for Industrial Biotechnology and Bio-based Products". This Policy Agenda was developed in consultation with the member companies and was published at the end of 2006 with the support of the Finnish Presidency. The key recommendations of the Policy Agenda have been included in the Lead Market Initiative (LMI) for Bio-based Products. This initiative received very strong political commitment from the Member States at the Spring Summit (13-14 March 2008) and at the Competitiveness Council (29-30 May 2008). At Commission level, an inter-service group (all DGs concerned) coordinated by DG Enterprise is tasked with ensuring the implementation of the LMI.

In addition, EuropaBio continues to:

• strive for policy coherence and legislation that offers consumers and farmers the right to choose.
• disseminate and implement the High Level Pharmaceutical Forum conclusions and recommendations at national level.
• participate to the shaping of the future of the biotech pharmaceutical sector in the EU by contributing to the Pharma Package discussions.
• raise awareness and advocate for 3Rs (Replacement, Refinement and Reduction) through our commitment to the European Partnership on Alternative Approaches to Animal Testing (EPAA).