Patients and consumers have the right to fair and equitable access to the products and services issued from biotechnology

Major developments

Orphan Medicines - pushing patients' rights to life-saving treatments

EuropaBio is shaping the EU policy on rare diseases through our policy agreed by the Healthcare Council this year of putting our weight behind the rights of patients to have access to life saving medicines. We are the only industry calling for a more harmonised approach to how orphan medicines are assessed and an improved access to Orphan medicines in Europe. We are tapping into many forums to bring our policies up to the highest levels: through the High Level Pharmaceutical Forum, which brought together EU Health Ministers but has now formally ended; through the EU Commission; our communication and support of Rare Disease Day; through our messages that we are bringing to Parliament, and in the capitals through our National Associations. Furthermore, we are active participants in the European Platform for Patient Organisations, Science and Industry (EPPOSI). The last year has also seen the rise of the EuropaBio Patients Advisory Group, which brings together patients representatives and members to discuss various issues of interest to both. Here, too, orphan drugs and rare diseases are high up the agenda.

Lead Market Initiative for Bio-based Products (LMI)

The subject of the lead market initiative for bio-based products are industrial and consumer products based on renewable, biological raw materials. It includes non-food bio-based products and materials such as bio-based plastics, biolubricants, surfactants, enzymes and plant-made pharmaceuticals. Bio-based products can substitute particular fossil-based products, and in many cases reduce greenhouse gas emissions and leave a smaller ecological footprint, i.e. generate less waste, and use less fossil energy and water. But for this potential to be realised, the market breakthroughs for these new products must speed up.

Meanwhile the Commission has set up an Ad-hoc Advisory Group which is tasked with providing recommendations on legislative changes and policies needed to develop a strong lead market for bio-based products in Europe. The Ad-hoc Advisory Group, including EuropaBio and some members, was officially constituted in September 2008. Three working groups have been created: a first one focussing on the impact of legislation and policies, a second one developing recommendations concerning standards, labelling and certification, and a third one looking at market drivers and public procurement.

European biotech crop cultivation grows despite limited product choice

EuropaBio released the latest figures on biotech crop cultivation in Europe totalling 107,719 hectares in 7 EU Member States in 2008 representing a 21% increase in those 7 countries compared to the previous year. The figures show that the cultivated acreage in biotech crops has increased almost 10-fold in Poland, doubled in Slovakia and increased substantially again in the Czech Republic (+68%). In Spain, where most of the EU's biotech crops are grown, the amount of cultivated acreages continues to grow (+5%) after 11 years of experience with the applied technology. In Europe, farmers have the choice of only one maize product which was approved back in 1998. This biotech crop is insect-resistant maize that contains a Bt gene, allowing the maize to defend itself against the European corn borer. However, at least 19 other biotech crops for cultivation are stuck in the EU approval system and EuropaBio continues to work for the approval of those products so as to offer European farmers the freedom to choose.

EU biotech cultivation in 2008
+ 21% in 1 year*
 

2008 - GM crop acreage in the EU increases by 21% in 7 countries

Challenges and opportunities

Access to raw material: developing recommendations for the new CAP

If Europe wants to develop a competitive Knowledge-Based Bioeconomy producing not only food and feed, but also biofuel, fine and bulk chemicals, bio-based plastics and materials, then the industrial biotechnology industry needs access to renewable resources (raw materials) at world market prices. Biomass availability and its price levels are both important elements. EuropaBio's Access to Raw Materials Working Group is looking at the biomass availability in Europe, and at the impact of the trade regimes and of European policies on the price of the feedstock. Its goal is to stimulate policies that allow access to competitively priced raw materials (availability and price) for the bio-based economy.

EuropaBio continues to:

• maintain efforts to advocate for further patient involvement in all healthcare-related platforms.
• work on rare disease and orphan medicinal products, in collaboration with a wide range of stakeholders, to support the adoption of the European Commission's vision for tackling rare diseases in Europe.
• ensure that the EU approval process for green biotech products functions and no unscientific national bans are put in place so as to offer farmers and consumers the right to choose approved ag biotech products if they so wish.