The Belgian Biotechnology Industry Organization

Annual report

2013

Part of

02

ANNUAL REPORT 2013

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 organizes consultation

with the policymakers; • European policy, as the national association

contact point of EuropaBio, the European Bio-technology federation;

• activities related to biotechnology within the OECD;

so that it is continuously able to establish bench-marks and anticipate the needs of its members.essenscia/bio.be 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 biophar-ma, REACH, FISCH, BIOCHEM and CINBIOS projects and the extensive network of partners (VBO, VOKA, UWE, BECI, CEFIC, Business Europe). essens-cia/bio.be members have access to all essenscia services and benefits.

essenscia/bio.be interacts directly with its mem-bers through its Board and its vertical working groups in relation to the health or red biotech-nology , agriculture or green biotechnology , biobased or white biotechnology; and through its horizontal working groups in relation to ISO/CEN standards, intellectual property, start-ups and

SMEs. The positions adopted are published on the site bio.be.

essenscia/bio.be :• organizes the training courses required, both

for its members and for the relevant stakehol-ders.

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

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

Mission statement essenscia/bio.be is the federation of Belgian

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

03

The members of the BOARD : Luc Kupers, Genzyme (Chair)Xavier Hormaechea, UCBMarleen Hoebus, AmgenPascal Lizin, GSKAnnie Van Broekhoven, Q BiologicalsRuth Laub, Laub Biological Science.Marc Martens, Bird & BirdBert Van Loo, DuPont Dirk Carrez, CleverconsultPatrick Rüdelsheim, PerseusGil Beyen, TigenixJo Vanwittenbergh, NautaDutilhJohan Vanhemelrijck, HIPPJohan Devenyns, Peptisyntha Cathy Plasman, Secretary General

After the introduction of our President of the Board, Luc Kupers (Genzyme) and deputy Prime Minister and Minister for Economy, Johan Vande Lanotte, we heard during the Horizontal issues session presentations on:• Towards a tax shelter for the biotech SME’s by

Christian Homsy, CEO Cardio3Biosciences• Patent policy for Belgian biotech companies :

are new perspectives coming up ? by Bruno Vandermeulen, Partner Bird & Bird

• Towards a Belgian and regional strategy for the biobased economy by Dirk Carrez, CEO Clever Consult

• Biotechnology in the agriculture by Johan Cardoen, CEO VIB

and a discussion lead by Carel du Marchie Sarvaas, Director Green biotech EuropaBio with France Fannez (Managing Director BioWin), Jean-Luc Wertz (Chef de projet Valbiom) ; Pierre Lamy (Manager Brussels Lifetech); Ann De Beuckelaer (Managing Director FlandersBio), and Cathy Plasman (Secretary General essenscia/bio.be).

During the Health Care part we listened to the presentations on the legislation on cells and tissues by Steven Hippe, FAGG/AFMPS and testi-monials from Promethera by Eric Halioua, CEO; TiGenix by Gil Beyen, CBO and Bone Therapeutics by Enrico Bastianelli, CEO.

This session was concluded by a lively interac- tion with the audience guided by Cathy Plasman (Secretary general Essenscia/bio.be), Bart De Greef (Expert pharma.be), Annie Hubert (CEO ESAH) and Gil Beyen (CBO Tigenix).

About 100 participants, a broad range from politi-cians and their advisors, till representatives from the industry and governments, were present that day. A lot of them were contacted since then for the follow up on the discussed issues. A brief over-view of each item is given in this report.

Policy day ‘towards an innovative biotech policy’

The bio.be yearly policy day ‘towards an innovative biotech policy’, February 26, gave the start for the acti-vities in 2013. The red line was the question if Belgian legislation and policy could follow the fast evolution

of new technologies within the biotech sector.04

05

ANNUAL REPORT 2013

The Belgian biotechnology sector has a lead posi- tion within Europe, as a result of years of public and private R&D investments and efforts. Important innovations are in the pipeline, some confirming Belgium at the top of world position. The high R&D intensity and long term research with high failure risk creates an environment where SMEs have huge difficulties to find venture capital at the needed levels and this especially in the health care sector.

The board of bio.be with the help of the mem-bers analyzed the situation, The board explored the possible solutions with different actors and concluded that a “tax shelter” for corporations funding those innovative biotech SME’s could - as in the audiovisual sector - close the financial gap. How could it work: it is structured as corporate income tax discount, where 150% of the invest-ment will be deducted from investor’s taxable base. Based on estimations of the need of capital

and the current pipelines, our proposal foresees 20 % investments via the tax shelter for the discovery and earlier stage projects and 50 % for the medium and late stage projects. A further tailoring was done for biotech SME’s investing in R&D&I (to be in line with the EU state aid guide- lines), in cooperation with KBC Securities.

A tax shelter for the biotech SME’s was supported by the federal and Walloon Government and our proposal was taken up in the “relance” package for discussion. If accepted and successful it could lead to clustering of different companies, resulting in the secondary effect of attracting foreign investors and companies and reinforce the Belgian lead in developing new solutions based on life sciences and Biotechnology.

Towards a tax shelter for biotech SME’s as a structural ‘relance’ measure

essenscia/bio.be published in cooperation with Clever Consult its policy document “Towards a Belgian and regional strategy for the biobased economy, June 2013” . It covers the strategies in different countries and an analysis of our policies in Belgium. The policy document essenscia, based on intense collaborations with our members, the regional clusters and several administrations lists the recommendations for both the regional and federal governments to support the transition towards a biobased economy. One of the major recommendations listed is: once the society has chosen to become more biobased, the efforts

of all governments and departments should be coordinated towards that goal that would lead to policy coherence at all level. A clear vision of the goal and permanent dialogue with the sector is adamantly important to set up that important so-cietal transition. bio.be started that dialogue based on its policy document and is willing to participate intensely in future consultations. The reference of Mr. Elio Di Rupo, Prime Minister to the bio.be policy recommendations in a major European Conference gives us a boost to continue preparing the future of the biobased society in Belgium. The document can be downloaded from www.bio.be.

Towards a Belgian and regional strategy for the biobased economy

06

ANNUAL REPORT 2013

EFIB, the ‘European Forum for industrial biotech-nology and biobased economy’ (www. efibforum.com), taking place in Brussels, October 1 and 2, 2013, in cooperation with EuropaBio and essenscia/bio.be, was a success. Now in its 6th year, EFIB successfully made the transformation from a small specialized conference to a market leading, pan European flagship event for this vibrant and dynamic sector of Europe’s bio- economy. The event had 700 delegates in atten-dance, 45 exhibitors and 20 technology showcase presentations.In his video-message (www.youtube.com) for the opening session of this event, Prime Minister Di Rupo says that transition and innovation are the key elements for our future and the sustainable use of biomass is there part of. He acknowledged that the federal government has still some tasks to do, in line with the appreciated recommendati-ons of the study “Towards a Belgian and regional strategy for a biobased economy”.

A lot of our companies as Galactic, Ecover, Solvay, SNS Lavalin, Clever Consult, Proviron and BioBase Europe gave a presentation or participated in the panels. The final debate with Mr. Antonio di Guilio, DG Research, European Commission, con-cluded that the need for stability and long term legal certainty is the most important issue for this sector, as well as for the public private partnership ‘Bridge’.It is also the “policy coherence” that is the overar-ching recommendation in the bio.be policy docu-ment “Towards a Belgian and regional strategy for the biobased economy, June 2013”.

“Belgianbooth@EFIB” organized by bio.be and its partners Greenwin, Valbiom, essenscia wallonie, GBEV, FlandersBio, Cinbios, Fisch and essenscia vlaanderen, generated many interesting contacts with numerous visitors and in between the part-ners.

EFIB, the ‘European Forum for industrial biotechnology and biobased economy’

07

08

09

ANNUAL REPORT 2013

In the field of cell therapies, the Belgian industry had clearly a head start with the very Europe’s first cell therapy product approved “Chondrose-lect” from Tigenix. Moreover an important range of products are under development – already in late stage - in the other companies. To maintain the world’s pole position , these companies need a stimulating policy environment in addition to coherent support to ensure their growth, future employment and attract investments. Research companies in this field face today unnecessary regulatory constraints and complexity hindering the access to cells and tissues and their use for the production of Advanced Medicinal Products, (ATMPs) :

Under current national legislation, the companies are reliant on hospital centers for the cells and tissues needed to manufacture their allogenic (from another person than the patient) ATMP’s BioBase Europe Pilot Plant, . However, the hospi-tals have no incentive to develop these services. This results in a disadvantage comparing to our neighbouring countries, as most countries follow the EU regulation that does not make a difference between allogenic and autologous (from the pa-tient) ATMP’s. This major regulatory constraint is hindering investors to support financially establis-hing manufacturing plants in Belgium. essensica/bio.be proposes to reduce the regulatory burden and bring the production of allogenic ATMP’s in line with the current system for the production of autologous ATMP’s.

Another obstacle is the absence of definition of the “hospital exemption” allowing by default hospital doctors to manufacture their own medicinal pro-ducts (cells for a specific patient) without having to meet the statutory requirements for quality, proof of efficacy or safety of the product they are administering. This exemption is provided for in a European regulation, but while exceptions are necessary, it is crucial that they be clearly defined. For instance, special cases permitting the use of products manufactured by the hospital when duly approved medicinal products are available for the

Advanced therapiessame purpose must be avoided. We are calling for the clear, precise and specific transposition of the conditions under which this hospital exemption can be invoked. Patient safety and the competiti-veness of the sector are at stake here.

The dialogue with the public authorities has just started under the framework of the Biopharma platform, a high level working group with the federal government. A lot of issues still need resol-ving. essenscia/bio.be and its cell therapy compa-nies were also involved in the activities (e.g. hearings) of the working group on “inno-vative therapies” in the Senate. The chair of this working group introduced recently a proposal to amend the law of December 13, 2008 (DOC. 5-2449/1) regarding allogenic ATMP’s. A proposal we fully support.

essenscia/bio.be worked also with pharma.be on the aspects of biobanks (Royal Decree) and biosimilars, as well as with EuropaBio on different health issues.

Within the ISO framework (International Organi-zation for Standardization), a new technical com-mittee was established in 2013 for Biotechnology. The scope defines the standardization in the field of biotechnology processes that includes the follo-wing topics: 1) terms and definitions; 2) biobanks and bioresources; 3) analytical methods; 4) biopro-cessing; 5) data processing including annotation, analysis, validation, comparability and integrati-on; 6) metrology. ISO/TC 276 will work closely with

related committees in order to identify standardi-zation needs and gaps, and collaborate with other organizations to avoid duplications and overlap-ping standardization activities. A position strongly defended by Belgium, whereas essenscia/bio.be is following this committee together with the NBN, Belgian Normalization Bureau and EuropaBio.essenscia/bio.be follows also the CEN TC411 for biobased products in cooperation with Federplast, another product group within essenscia.

A new ISO Technical Committee 276 for Biotechnology

The signing on 19 February 2013, by the 25 EU Ministers of the Unitary Patent Court Agreement in Brussels, creating an unitary patent with uniform protection within the territory of the participating Member States, is welcomed by the members of bio.be improving the entrepreneurial environment and stimulating innovation. essenscia/bio.be supported the demand for a Belgian representative chamber. This will keep the local patent expertise and even Belgian judges. It is of importance for Belgian companies to have access to a nearby located Patent Court, to con-front international claimants and defendants and an access to a Patent Court in their own language. This maintains also our attractiveness for invest-ments in innovations and technology.

essenscia/bio.be informed the minister for Eco-nomy, the European Commission and EuropaBio, in line with the LESI (Licensing executives society international) comments on the proposed amend-ments to the Technology Transfer Block Exemp-tion Regulation (TTBER) and specific the draft Article 5(1)(b) that excludes from automatic exemption any clause containing: “any direct or indirect obligation on a party not to challenge the validity of intellectual property rights which

the other party holds in the European Union, including any right for a party to terminate the technology transfer agreement in the event that the other party challenges the validity of any of the intellectual property rights which a party to the agreement holds in the European Union.” We asked to keep the termination clauses, as this is of utmost importance for start-ups and SMEs. The federal Economy administration defended our position at EC level. The follow up is done in assistance by our members active within LESI (Bird&Bird, Ablynx) and the VIB.

essenscia/bio.be follows together with the Euro-paBio IP working group, the ongoing work by the European Commission regarding the implications of patent law in the field of biotechnology and genetic engineering. They are preparing a status report on the Biotechnology Directive (98/44/EC) with specific analysis and suggestions, particular-ly in the area of breeding exemptions.

IP: Intellectual Property

10

Site visitA visit to the new BASF CropDesign facility in Ghent took place on 3rd October. Visitors from European and national Belgian Institutions and industry stakeholders toured the labs and green house. Presentations on current innovative research in plant biotechnology, challenges and oppor-tunities in the EU was the theme of the day. The visit furthermore marked the 30th anniversary of the world wide first successful introduction of a gene into a plant in Ghent, enabling the starting point of genetic modifica-tion (GM). Ghent is the birth place of GM technology, and today holds the highest concentration of plant biotechnology companies in Europe.

ANNUAL REPORT 2013

11

The first European Biotech Week, organized by EuropaBio together with the National Associa-tions, took place in 2013 from 30th September to 4th of October and marked the 60th anniver-sary of the discovery of the DNA molecule. This momentous occasion opened the door to a large number of activities and stimulating dialogues improving understanding between the societal partners and underpinning the societal value of innovations in the Life Science sector. Around 100 events took place across Europe (www.biotech-week.org). essenscia/bio.be organized a GMO workshop, a Research and production site visit and was intimal involved in the EFIB activities.

European Biotech week

GMO workshopA workshop was held at the federal Parliament for students from the Université Libre de Bruxelles (ULB) and members of the Belgian political, busi-ness and NGO communities.

A group of students enrolled in master’s program-mes in communication and information obtained the highest grade from an academic jury for their work on media reporting of issues concerning genetically modified organisms (GMOs) conducted over the last semester. Students were assigned to analyze media reports, using the 2012 GM maize feeding study carried out by Seralini et al as a case study. The way such issues are reported was ana-lyzed and shed light on various interest at stake.

12

essenscia/bio.be participated in the Belgian booth at the BIO International Convention San Francisco April 22-25 and discussed with the other biotech associations common issues, e.g. in the field of trade agreements (US/EU and US/Asia), IP (follow up India), ISO biotech. An agree-ment was made that EuropaBio together with Bio US should act together on legal level (e.g. with regard to unlawful release of confidential business information). To enhance the coope-ration with the National Associations, a share point site will be developed and an International Council of Biotechnology Associations (ICBA) will be established.

essenscia/bio.be had a booth at the “Knowledge for Growth” Conference, organized by FlandersBio, May 30.

essenscia, Janssen Pharmaceutica, bio.be and Biocom Southern California organized for the

Cooperation with other associations

economic mission to Los Angeles/San Francisco, June 2-9, the seminar “From Belgium to the US, world leaders in biotech” in cooperation with the regional clusters and member companies (e.g. Eurogentec, also having a plant in San Diego). This event took place at Janssen Labs, a new life science innovation center in San Diego. It offers a capital efficient way for companies to discover and deve-lop solutions to the healthcare challenges we face today. This model is intended to give companies the opportunity to invest their capital in research instead of infrastructure and to focus resources on progressing science instead of day-to-day operati-ons (www.janssenlabs.com).

essenscia/bio.be organized with Cancham Belux and BIOTECanada on October 17 the event “per-spectives for long term cooperation between Bel-gium and Canada”. Ablynx, SNC Lavalin and UCB gave testimonials on their experiences in Belgium and in Canada.

ANNUAL REPORT 2013

13

essenscia/bio.be assists in communication of events organized by other biotech associations if they give a reduced entree fee to our members, e.g. essenscia/bio.be was supporting partner for the Australia’s Biotech Invest conference, 28-29 October in Melbourne.

essenscia and bio.be received on November 25 a Malaysian delegation covering the whole biotech sector and lead by the Malaysian Investment Development Industry (MIDA). They are speci-fically looking for investments in their country. We presented “Invest in biopharma” and the acti-vities of essenscia/bio.be, whereas there is a stra-tegic cooperation agreement with BiotechCorp. As some Belgian companies are interested to invest or have already invest (e.g. Oleon), this agreement could be renewed within the framework of the economic mission in 2014.

essenscia/bio.be participated at the OECD/BIO-COM AG workshop “Status and Prospects of the Biotechnology Sector in Central Europe”, Decem-ber 3. For the first time, Switzerland, Austria and Germany surveyed their national biotech sectors under a harmonized OECD framework. As our federal economy administration is updating their 2006 study ‘Economic potential of the biotech sector in Belgium’, in cooperation with our sector, it was worthwhile to look over the borders to see how they did it and what the results are. “Having done well in the past doesn’t mean you’ll lead in the future!” – that’s how Switzerland’s ambas-sador to Germany Tim Guldimann set the tone for this multinational workshop in Berlin. There was a good discussion on how national governments can measure and promote the biotech industry in their respective countries. The results of the OECD-compliant surveys, including the sector definitions and information on the methodology used, can be downloaded from www.european- biotechnology-news.com. A presentation is fore-seen at our next yearly seminar, February 18, 2014.

BIOCOM AG

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

Some of this work only relates to Belgian situati-ons, as for example the recent investigation of the European Commission concerning state aid for YICS (young innovative companies). In this case, essenscia/bio.be contacted directly their members and the minister for Finance, as well as the regio-nal clusters.

essenscia/bio.be works within essenscia with the other departments and product groups, and assists the essenscia Board. We gave with our members a substantially input in the Sustainable Development report (www.essensciaforsustaina-bility.be), and worked also for the Health forum, April 26.

Day to day work

14

ANNUAL REPORT 2013

15

• essenscia/bio @ Lifetech Brussels Annual event, January 23 (presentation tax shelter)

• essenscia General Assembly and seminar ‘politics and innovation’, February 18

• essenscia and bio.be biotech event in cooperation with Novartis and Awex in Basel, March 11

• essenscia/bio.be workshop on the tax shelter

• essenscia/bio.be & NBN workshop on the ISO TC 276 Biotechnology

• essenscia/bio.be @ Knowledge for Growth, FlandersBio, May 8

• Launch at BIO International Convention San Diego, June 23 – 26, of the International Council of Biotechnology Associations (ICBA), with essenscia/bio.be as one of the founding members.

• essenscia/bio.be & FBBF symposium, in cooperation with the regional clusters, first week of October

• European Biotech week from 6th to 14th October

• essenscia/bio.be @ BIOWIN DAY, November 26

• Economic mission to Malaysia & Singapore, November 22-28, with the renewal of our agreement with BiotechCorp Malaysia

Activities in 2014, a selection

• An attractive fiscal climate - expand the tax system for Masters to bachelors, e.g.

the current system for YICs (young innovative companies) - 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

• Decrease the energy prices

• Advanced therapy medicinal products : bring the allogenic pro-duction in line with the autologous production; define hospital exemption; make work of the royal Decree on biobanks

• Biosimilars

• A harmonized European GMO policy for a sustainable agriculture

Memorandum 2014, the highlights

Contact

essenscia/bio.beBelgian Biotechnology Industry OrganizationDiamant Building Boulevard Auguste Reyerslaan 80++ 32 2 238 98 44secretariat-bio.be@essenscia.bewww.bio.bewww.essenscia.be

Part of