New breakthrough in negotiations around orphan drugs23/06/2016 - Kristien Reekmans, Pharmaceutical Project Engineer
The latest developments in the market for orphan drugs are promising. In addition to the Netherlands and Luxembourg, the Flemish minister of public health Maggie de Block also reached an agreement with Austria on cooperation regarding orphan drugs. In my opinion, this is an important step forward in the negotiations with the pharmaceutical industry.
The market for orphan drugs
Orphan drugs are medicines to treat very rare diseases, also called ‘orphan diseases’. Currently, there are almost eight thousand orphan diseases, but hardly 150 orphan medicines to treat them. The reason? Developing and producing orphan drugs is expensive. Too expensive for most pharmaceutical manufacturers. Because of the rarity of orphan diseases, manufacturers aren’t able to produce the drugs in large quantities and research costs are relatively high compared to the market. The drugs lack a sufficient profit model.
Fortunately, the agreement with Austria brings us one step closer to Europe’s dream: the manufacturing of truly non-profitable orphan drugs for the whole of Europe. Together, the Benelux and Austria have a solid case in the negotiations with the pharmaceutical industry. After all, it’s an economic principle. The more citizens – and therefore patients – you represent, the more pharmaceutical companies tend to listen to your requests. These requests are focused on bringing down the costs of orphan drugs for both patients and health insurance companies. For example by offering clinical research subsidies or by enhanced patent protection to companies producing orphan drugs.
How about the future?
The agreement is great news for patients in the Benelux and Austria. It creates more profitable circumstances for small pharmaceutical companies to request approval for their orphan drugs in these four countries. If accepted, companies will have access to a bigger market immediately compared to a request for just one country. This way, patients will have faster access to innovative technologies, methodologies and medicines. The future looks bright, because the agreement with Austria is just the beginning. The Belgian government strategically chooses to extend the agreement country by country. When other countries will notice the benefits, they will join the agreement. And by then, they have to follow the existing rules. A very smart strategy to achieve the final goal: orphan drugs, available for everyone in Europe.