The field of Pharmaceutical Biotechnology in Health Care is developing rapidly. The worldwide sales of biotechnology- produced pharmaceuticals continue to increase significantly. For instance in 1990 the US sales amounted to approximately $2.0 billion these sales has been increased to $7.7 billion in 1995. This is almost 10% of the total US pharmaceutical sales. Not only sales figures distinguish biotechnology-produced pharmaceuticals. Many of these compounds are indicated for the treatment or prevention of serious life threatening or rare recurring, so called "Orphan" diseases. Also the quality of life of patients is often dramatically improved by these compounds.

 

Click here to see the list of members of Biofarmind. 

BioFarmind

BioFarmind was set up in 1998 by a few pharmaceutical biotechnology companies who did believe there was a strong need to set up this foundation. The additional value of biotechnology- produced pharmaceuticals for human health care must be brought to the attention of society and policymakers.
Only companies with Pharmaceutical Biotechnology as their core business can participate in this new Foundation. BioFarmind wants to look after the interests of these companies and bring the additional value of biotechnology- produced pharmaceuticals on the political agenda.

 

1. to stimulate and mould the basic research with biotechnology-produced pharmaceuticals. A collaboration research program has to be developed together with the Dutch authorities.

2. to inform all health care parties concerned about the new 'biotech' developments in the "gene" millennium. All parties involved has to keep up with the scientifically rapidly developing biotechnology research.

3. take away prejudices in general against pharmaceutical biotechnology by improvement of societal information.

4. to discuss with our local authorities the rules which work out badly for the development of biotechnology in our country.

There are some working-groups active within the organisation of BioFarmind. Working-groups which have a specific area as point of attention. There are working-groups occupied with for example Reimbursement; Farmaco-economics; Orphan Drugs; Research & Development and Public Affairs.
Hereafter the activities of some of these working-groups are mentioned.

 

In the Netherlands there are no legal rules for the price setting of pharmaceuticals and in comparison to the other Member-states of the European Community, the consumption rate of pharmaceuticals in the Netherlands is one of the lowest.
Nevertheless also in Holland the government develops costcontainment programs in an effort to manage the increasing costs in health care. Costcontainment programs for the consumption of pharmaceuticals in the Netherlands are also developed. The key-driving word in this discussion is "effectiveness". Pharmaco-economic guidelines based on the Canadian guidelines are developed by the Dutch Health Insurance Council. These guidelines have to help our government to control the volume of new pharmaceuticals.
The "reimbursement" working group of BioFarmind analyses the hurdles for biotechnology-produced pharmaceuticals entering the market. We want to sit at the table and discuss the interfering issues important for our 'biotech' business.

 

On July 27, 1998, the European Commission approved a proposal for a European Parliament and Council Regulation on orphan medicinal products.
Orphan medicinal products refer to rare diseases which are life threatening or chronically debilitating with a low prevalence.
The majority of these rare diseases are developmental disorders of a genetic or other kind, and therefore biotechnology provides powerful tools for the development of treatments for such diseases.
Often the availability of a treatment for a rare disease makes it a little less rare because of increased awareness (clinicians might not recognize a specific rare disease in a patient without specific knowledge about or attention for the disease.).

Examples of such rare diseases for which therapy has been developed or is being researched are Lysosomal Storage disorders like Gaucher, Pompe, Fabry, Hurler, Hurler-Scheie, Scheie, Mucopolysacharidosis I, but also for Hansen disease, hemophilia, Multiple Sclerosis and many others.
In general, medicinal products for rare diseases offer little prospect for fair return on R&D investments because the potential market is small.

The US, where the Orphan Drug Act has been one of the most successful pieces of health related legislation, enacted approximately 150 new FDA approved orphan medicinal products including reimbursement. This also fostered the creation of many small and medium sized biotechnology-based enterprises.

Therefore, EU wide incentives such as a 10-year market exclusivity, fee waivers and member state level incentives such as tax credit are expected to substantially increase the number of medicines developed by industry for such orphan disorders.

However the development of these products in EU is in its infancy. Not in the least because of the absence of structural reimbursement once these products have been approved by the European Agency for Medicinal products, EMEA.
The new European Regulation is expected to go into effect at the latest in the beginning of the year 2000.
EU member states should provide supportive reimbursement legislation in addition to the EU regulation to enable a return on R&D and marketing investment on these essential medicinal products in Europe.

 

"Leading edge biotechnology that meets the challenges of modern medicine."
In R&D programs biotechnology more and more plays an important role of which reproductive health, immunology/oncology, growth and metabolism are important fields of interest.
For some time now, the medical value of therapeutic proteins has been clear. The challenge has been to produce them in quantities sufficient for clinical use. Biotechnology and the ongoing evolution of advanced manufacturing processes were put to the task of meeting this challenge. As a result, the practice of medicine will never be the same.
In recent years recombinant DNA technology is often adopted as the preferred method for the production of a new generation of complex, recombinant therapeutic proteins.
Many companies chose recombinant DNA technology because it replaces the isolation of complex proteins from human tissue, blood or urine, leading to safer and purer products. It also offers the opportunity for large-scale production of proteins hitherto only obtainable in small quantities. Finally the method is environmentally friendly.
All pharmaceutical companies are committed to maintaining the highest standards of purity and safety. As with all genetically engineered products, stringent methodology and validation are required in the manufacture of mammalian cell derived therapeutic proteins.
There are strict guidelines for the purity and safety of recombinant products. All are committed to keeping the amount of impurities, both on the level of DNA and viral contamination, in accordance with recognized industry standards.
With a thorough understanding of biotechnology and a reputation for innovation, the biotechnological Pharmaceutical Industry faces the future with continued dedication to improving the quality of live for millions of people around the world.

 

Plein 22d,
2511 CS Den Haag
The Netherlands

Postbus 11636,
2502 AP Den Haag
The Netherlands

Phone +31 70 - 363 48 50
Fax +31 70 - 427 54 17

Website: www.biofarmind.nl
E-mail: info@biofarmind.nl

Office:       Drs.M.J.Gerritsen, E-mail gerritsen@bpra.nl
Chairman:  ir.J.G. Hanstede,  E-mail info@hanstede.nl