Annual report 2014

The Belgian Biotechnology Industry Organization

Annual report

2014

essenscia where chemistry meets life sciences

Part of

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Mission statement

Bio.Be is the federation of Belgian companies active in the biosciences and is part of essenscia (chemicals and life sciences).

essenscia/bio.be represents the interests of its members as regards legislation and standards at various policy levels (Belgium, EU, OECD).

Its mission is to create a stable legal framework in line with the trend for innovation, an essential factor for the economic sustainability and growth of employment in this sector.

To this end, essenscia/bio.be keeps a close eye on: • policy in Belgium and organises consultation with the policymakers; • European policy, as the national association contact point (NAC) of EuropaBio - the European biotechnology federation; • consultation on biotechnology within the OECD; so that it is continuously able to establish benchmarks and anticipate the needs of its members.

Essenscia/bio.be can can rely on the synergy within the essenscia group (product groups and pharma.be) and has access to the available expertise via the SME bureau; the patent unit, Invest in biopharma, REACH, FISCH and CINBIOS projects and the extensive network of partners (VBO, VOKA, UWE, BECI, CEFIC, Business Europe). essenscia/bio.be members have access to all essenscia services and benefits. essenscia/bio.be interacts directly with its members through its thematic working groups: agbiotech, cell therapy, fiscal incentives for SME’s, biobased standards (CEN), ISO Biotech standards (biobanks, bioprocessing), Nagoya Protocol, ... The positions adopted are passed on via the bio.be site.

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essenscia/bio.be • organizes workshops in relation to actual policy issues, both for its members and for the relevant stakeholders.

• promotes and represents its members in other relevant organizations and bodies at home and abroad.

• cooperates with other federations, network organisations, academics and various other players and facilitates consultation among them.

The members of the BOARD : Luc Kupers, Genzyme (Chair) Xavier Hormachea, UCB

Marleen Hoebus, Amgen Pascal Lizin, GSK

Annie Van Broekhoven, Q Biologicals

Patrick Jeanmart, Cardio3Biosciences Marc Martens, Bird & Bird Elke Janssen, NautaDutilh Bert Van Loo, Genencor

Dirk Carrez, Cleverconsult

Patrick Rüdelsheim, Perseus Toon Musschoot, Syngenta Ruth Laub, Red Cross

Piet Serrure, Peptisyntha

Cathy Plasman, Secretary General

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The bio.be General Assembly & Seminar ‘Elections in sight : politics & innovation’, February 18, gave the start for the activities in 2014. An in depth discussion took place about the bio.be Memorandum 2014-2019 and where there was a match with the different political programs.

Seminar ‘Elections in sight : politics & innovation’ Cathy Plasman, Secretary general bio.be, highlighted in her introduction the specific proposals the biotech sector made to the federal and regional governments : • An attractive fiscal climate for R&D (expand the tax system for Masters to bachelors, adapt IP and tax credit system in favour of YICs, a tax shelter for biotech SMEs) • Sustainable innovation by a coherent and consequent policy • Towards a sustainable biobased economy • A positive framework for the development of biological medicines (cell therapy, biologicals versus biosimilars) • A harmonized European GMO policy for a sustainable agriculture The bio.be Memorandum is part of the essenscia Memorandum (essenscia.be) and EuropaBio Manifesto (EuropaBio.org) and is available via bio.be@essenscia.be (print of pdf).

The testimonials by the CEO’s André Roef, Bayer CropScience; Frédéric Van Gansberghe, Galactic and Jean-François Pollet,Novadip (see You tube – bio.be policy messages) and following presentations :

• The Scientific and Economic footprint of the Flemish Biotech, Sam Sluismans, Innovation Director, Deloitte; • Belgian TTOs and their spin-offs. A match made in heaven? Elke Janssens, Partner NautaDutilh; • The Biotech sector in Switzerland, Austria and Germany (OECD/BIOCOM). Dr. Boris Mannhardt, Executive Vice President BIOCOM AG; gave a good view of the current situation in Belgium and abroad, as well as what the policy should be to keep our biotech sector on the top level.

The political feedback came from the Chief of Cabinet of Minister for Innovation, Ingrid Lieten, and the debate with members of Parliament Philippe De Backer (Open VLD) - Matthias Diependaele (NVA) - Muriel Gerkens (Ecolo) David Clarinval (MR) - Koen Van den Heuvel (CD&V) - Björn Rzoska (Groen) - Cédric du Monceau (CdH). The debate was lead by Jérome Van Biervliet (VIB) and Jan De Kerpel (KBC Securities). Luc Kupers (Genzyme), chair of the Board concluded this interesting day.

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ISO biotechnology

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essenscia/bio.be organized in cooperation with the NBN (National Bureau for Normalisation) a workshop, April 22, on the new ISO biotechnology committee (TC 276). A brief explanation on how the ISO – International Organization for Standardization) works, how to become a member and about the scope of this new committee was given.

Mr. Dagher from France presented their proposal for a management system for biobanks. This will be the basis for further work within the biobanks working group under this committee. In meantime the public actors (regional biobanks and Belspo –BCCM, Belgian Coordinated Collections of Micro-organisms) joined the Belgian mirror group as member, as well as bio.be (chair) and one of

CEN Biobased On European level, the technical committee 411 within the CEN - Centre for European Normalisation - made a lot of progress. The November plenary meeting discussed i) the mass balance methods to define the bio based content, ii) sustainability criteria and iii) LCA. Normally this work will be finalized in 2015. essenscia/bio.be, Federplast and some of their members follow this close by as the result of all this work will be very important for our industry. It is intended as a worldwide standard.

its members. We follow also the working group on bioprocessing, that defined the current work program : methods to control bioreactor processes for cell culturing; raw materials control for bioprocessing; best practice in raw materials selection in the design of human cell therapy manufacturing processes. The future work items are component material control; bioreactor processes; collection, separation, purification and formulation; handling, transportation and storage.

It is is important to be present within this committee with a strong voice from the industry.

You can still join.

EC investigation concerning state aid for young innovative companies The European Commission, DG Competition started an investigation regarding our state aid regulation for young innovative companies (YIC).

We took the initiative to discuss this with the Cabinets of Finance Minister Geens/Van Overtveldt and did the follow up with the involved member companies and the finance administration. The essenscia social division gave a lot of support concerning the asked information. It was clear that there has been a mix up of the withholding tax exemption falling under state aid rules (Bachelors) and the one for Masters (no state aid), as the fiscal reporting in Belgium did not made a distinction.

The Commission recently dropped the case due to

this misinterpretation. There were no exceedings of the levels allowed (thus no risk for payback), but the system needs some changes to be in line with the EC guidelines. The 10 yrs period will be shortened to 6 yrs. We want that this will be settled soon and await a proposal from the Government.

We and the social division worked together for the information meetings of Belspo (federal science policy) regarding the obligatory R&D reporting, that came info force Jan 1, 2014. An information session was also organized by Biowin, Lifetech Brussels, FlandersBio and Deloitte, with our support.

Advanced therapies essenscia/bio.be worked further with the member companies and the Senate working group on ‘innovative therapies’ regarding the allogenic use of ATMP’s and the issue of ‘hospital exemption’. The Chair of the Senate working group on ‘innovative therapies’ proposed to amend the Health law of December 13, 2008 (DOC.5-2449/1), but didn’t got the majority of the votes. An advice of the High Health Council was asked by the Senate. This subject was taken up after the elections with the new Minister for Health, De Block and a meeting will take place with her services Jan 2015. The draft Royal Decree on Hospital exemption will also be on the agenda. In meantime, there is alo an advice of the High Health Council. essenscia/bio.be and its members commented also involved on the EC public consultation on quality and manufacturing requirements for ATMPs in cooperation with EuropaBio and bio.be was represented at the EMA CAT stakeholdermeeting.

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Tax shelter for biotech SME’s During the Belgian - Swiss Biotech event, March 11 at the Novartis headquarters in Basel, in cooperation with essenscia “Invest in Biopharma” and bio.be, Minister Alexander DeCroo supported our proposal for a tax shelter for biotech SME’s (launched in 2013). Especially as they decided to set up stringent rules for the banks, he explained that it will be more difficult to find capital for high risk investments and the government has the task to look for other options, like the tax shelter. His statement was taken up by the press. bio.be made some extra calculations for the ‘relance’ discussions, but no decision was made. Nevertheless Finance Minister Geens declared during our seminar Oct 8, that he supported this idea if the European Commission would accept it. The essenscia/bio.be tax shelter workshop (Nov 3) with the Finance administration, Belspo, KBC securities and member companies, discussed this proposal, as well as some alternatives and current systems in other countries.

To get an overview of the latter, the annual report ‘Biotechnology in Europe: The Tax, Finance and Regulatory Framework and Global Policy Comparison’, by Ernst & Young in cooperation with EuropaBio and its national associations is available via europabio.org. The conclusions of our workshop will be presented by members of our fiscal working group (Cardio3Biosciences, UCB, Nautadutilh) to his successor, Minister Van Overtveld.

IP52.org The Patent Cell of essenscia (www.essenscia.be/octrooicel) focussed its technology watch on biotechnology in cooperation with VIB and essenscia/bio.be. This project is partly funded by the federal economy administration, with the aim to raise awarenss of IP in the biotech sector.

Interesting information on IP can also be found on the IPR helpdesk (www.iprhelpdesk.eu). We worked together with EuropaBio and Croplife International on the new site IP52. org. It has information on intellectual property and a weekly newsletter with new IP resources, including videos, case studies, and infographics.

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Biobased biconsortium launched their first calls

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The consortium of the biobased industries has worked intensively.

3.7 billion is now available, both from the industry (main part) and the EC. Calls were open from June on and there is a close collaboration with the European Investment Bank (EIB). How to apply is explained at BIC (www.biconsortium.eu) and BBI (www.biobasedppp.eu). Companies can still join BIC as well.

Cleverconsult, a bio.be member, is one of the companies that took the initiative for this consortium. essenscia/bio.be supports also other projects as the Bio Base Europe Pilot Plant and follows the European policy via EuropaBio and CEFIC.

REACH & biotech : seeking for a solution Industrial biotechnological and laboratory operations commonly use Boric acid in culture media.

Catalytic amounts of boric acid are commonly and safely used and essential to activate the fermentation processes related to biotechnological industry for (technical, food and feed) enzymes, food additives, cultures, single-cell proteins, bioethanol and organic substances. Scientific studies have shown that the substance cannot be substituted with any other substances due to the biological essentiality of boric acid. The proposal of ECHA for the listing in Annex XIV (Authorization list) would jeopardize the legitimacy of activities such as cell growth or cell proliferation during fermentation and would have several impacts: • The burden to seek authorization for any use of Boric acid would be disruptive to the entire EU biotechnological fermentation industries and the availability of pharmaceutical products as well as Technical, Food and Feed products produced in Europe.

• The burden to seek authorization for any use of Boric acid would most likely lead to relocation of production units of fermentation companies outside of the EU, thus impacting on European

Member States economies and their competiveness on the global market.

• The burden to seek authorization for any use of Boric acid will also create a negative competition effect for small and medium size companies in comparison to large fermentation companies. essenscia/bio.be and some of its members responded to the public consultation and the EC. We worked mainly together with the Association of Manufacturers and Formulators of Enzyme Products (AMFEP), and also with EuropaBio, EFPIA and CEFIC. Comparable to the proposal for inclusion of cobalt salts in the Authorization list

by ECHA last year, we noticed that most of the companies are not aware of the consequences or not even of their use of it.

So we did several specific mailings. We reached in meantime for the cobalt salts - cobalt dichloride and cobalt sulphate - a postponement, in order to clarify if the risks would be better controlled via restriction under REACH, taking into account use of the substances in culture media in biotechnology, pharmaceuticals and in vitro diagnostics.

Biodiversity Convention & Nagoya Protocol : national implementation This agreement of the international community on access to genetic resources and the sharing of benefits aims to contribute to the global preservation of biodiversity. It gives legal certainty for biotech companies, as it encourages research and the creation of value and benefits from genetic resources. As the Protocol has to be implemented now in national legislation (before Autumn 2015, one year after its entry into force), we work in close cooperation with the National Focal point

(federal/regional). It is very important that we avoid any extra administrative burden and that our industry profits from easy access rules in Belgium. As genetic resources are used in all our products & processes, our goal is a fair and equitable sharing of benefits. Within EuropaBio a set of best practices are in preparation that can be used for the discussion on EU as well as on national level.

Site Visits A yearly tradition are the visits to one of our member companies. This year we went with a delegation of the European Commission, other Associations, and policy makers to Genzyme in Geel and Syngenta & VIB in Ghent. We discussed inter alia the issue of biosimilars and the intentions of the European Commission to restrict the cultivation and trade of GMO’s.

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Cooperation with other associations

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essenscia/bio.be organized in cooperation with essenscia “Invest in Biopharma” and Swiss Biotech, the Belgian - Swiss Biotech event, March 11 at the Novartis headquarters in Basel. Minister Alexander DeCroo joined this mission and gave his view on the sector (see tax shelter above). essenscia/bio.be participated in the Belgian booth at the Bio International Convention San Diego, June 23-26 and discussed with the other national biotech associations common issues, e.g. in the field of trade agreements, IP, ISO biotech. To enforce this cooperation, the International Council of Biotechnology Association (ICBA) was launched during that week. Bio US has the chair and EuropaBio has the vice chair. An extranet application supports the exchange of information between the different countries. essenscia/bio.be had a booth at the ‘Knowledge for Growth’ Conference (FlandersBio) May 8 and at the BiowinDay, Nov 26.

essenscia/bio.be took part in the Croplife Media Tour in IOWA (Oct 13-17), guiding the European Journalists within the domain of agbiotech. A visit to the Pioneer research centre and glasshouses, visits to farmers and participation at the World Food Prize Conference (www.worldfoodprize.org) were on the agenda. The development of different traits, also in relation to health and climate change was clearly explained (Isaaa.org/ cropbiotechupdate). The stories from farmers coming from Southern countries were very interesting. Having access to all technologies is their priority, so they can earn more and send their children to school. essencia and bio.be worked closely with AmCham for the visit of a biotech delegation from Alabama visit and prepared in collaboration with the Chemical Association in Malaysia and BiotechCorp a green chemistry and a biopharma event during the economic mission to Singapore & Malaysia from Nov 22-28. Visits to to the Oleon plant and GSK were also on the agenda.

Biotech week 14

GM on social media

The European Biotech week (biotechweek.org @biotechweek) took place from October 6 till 12.

Aa series of activities were organized by essenscia/bio.be to bring the spotlights on our sector.

A big information campaign about GM technology started the same week. The twitter action #mybiotech for the overall public on European level gave a lot of information about research and development, as well about the benefits. Our industry (BASF Cropdesign, Bayer CropScience, DuPont, Monsanto Company and Syngenta) launched in 2014 also the information sites growingvoices.org for Europe and gmoanswers.com on the global level, both with the aim to give the right data and information.

Biotech : trends & expectations in cooperation with FBBF – EuropaBio – E&Y During the first day, October 6, we started with the high level seminar about the trends and expectations of the biotech sector on a global and european level, with a special focus on Belgium.

There were 3 very interesting keynote speeches

by Tom Heyman (CEO Janssen Pharmaceutica Belgium), Jo Bury (Managing Director VIB) and Jack Staloch (VP Cargill, Director R&D Biotech) and presentations by Carlos Tenreiro (EC DG Competition) about the new European State aid guidelines and Siegfried Bialojan (Head E&Y Life Sciences Mannheim) about their Global Biotechnology report.

Joanna Dupont (Director Bioeconomy EuropaBio) and Patrick Van Beneden (Executive VP GIMV LS) joined the others for the debate and Minister Geens closed the day with some good prospects about our tax shelter proposal.

Exhibition A selection of ‘Everyone’s a GENius, the surprisingly combination of science and cartoons’ from the International Cartoon Festival Knokke-Heist 2014 & KULeuven, was shown during the seminar.

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Follow @essensciabiobe @EuropaBio @GrowingVoicesEU @GMOAnswers #mybiotech.

We asked students in Belgium to be part of this twitter campaign and to give feedback on how they think about GM products, via : 1. the publication of the magazine MENS (www. biomens.eu) for students about the science behind GM technology (part I) and about the societal aspects (part II). 10.000 prints were distributed and a school game around this theme will follow in 2015-16.

2. The focus on GM during the Biotech week on the essenscia student site www.breakingscience.be

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Day to day work

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essenscia/bio.be is together with its member companies (some of them are also EuropaBio member) actively involved in the EuropaBio work (EuropaBio.org) and in the CEFIC biobased work. A good interaction is necessary to address the European issues at our federal or regional governments and vice versa. The positions are well prepared by our working groups (members can always join) and our Board. Feedback to the members is given by essenscia - and direct bio.be mailings.

Some of this work only relates to Belgian situations, as for example the recent investigation by the EC concerning state aid for YICS. In this case, essensia/bio.be contacted directly their members and the minister involved, as well as the regional clusters. essenscia/bio.be works within essenscia with the other departments and product groups, and assists the essenscia Board. bio.be members are also member of essenscia and can thus rely on all the available services (social department, prevention, environment, ...)

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Activities in 2015, a selection • essenscia/bio.be @ bioentrepreneur Paris, Jan 29 • essenscia/bio.be @Lifetech Brussels Annual event, March 5 • essenscia/bio.be @ Knowledge for Growth, FlandersBio, May 21 • essenscia/bio @Debelux, June 1-3 • essenscia/bio.be @ Milan World expo, June 5 • essenscia/bio.be @ Bio International Philadelphia, June 15-18 • European biotech week, Oct 12 -19 • essenscia/bio.be event Oct 12 & visits Galactic & Cell Therapy, Oct 13 &15 • EFIB, European Biobased Forum Oct 27-29, Belgian booth & organization • essenscia/bio.be workshop ISO bioprocesses • essenscia/bio.be workshop CEN biobased • Economic mission to Canada Oct 24-31

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Contact essenscia/bio.be

Belgian Biotechnology Industry Organization Part of

Diamant Building

Boulevard Auguste Reyerslaan 80 ++ 32 2 238 98 44

Bio.be@essenscia.be www.bio.be

www.essenscia.be

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