The availability of medicines is under pressure. People increasingly have to wait longer or are prescribed an alternative, with all the consequences this entails. That has to change.
The problems in Europe surrounding the availability of medicines have grown in recent decades. Europe is almost completely dependent on China and India for crucial, generic medicines such as painkillers, blood pressure reducers and anti-inflammatories. Generic drugs are medicines whose patents have expired, allowing multiple manufacturers to make them. This is about 80% of the drugs available at pharmacies. "We as the Netherlands and Europe need to become less dependent on Asia when it comes to the production of these drugs," believes Weite Oldenziel, ceo and owner of drug developer and manufacturer Ofichem.
A new factory
To make that happen, Ofichem - together with the NOM and others - is working on an ambitious plan: rebuilding a pharmaceutical production capacity in the Northern Netherlands. The company already produces drugs on a small scale, but to date this has mainly involved small quantities of innovative drugs. This is done in collaboration with startups or academic centers developing new drugs. Oldenziel: "The plan to start producing generic drugs again in the Netherlands is perhaps somewhat naive and opportunistic, because there is currently no revenue model for it. But I see, partly because of two nieces with epilepsy and their uncertainty around crucial medications, the need to look at a solution closer to home.'
Gerard Lenstra, internationalization project manager at the NOM and involved in the development of the life sciences & health ecosystem in the Northern Netherlands, agrees. 'The goal is to be able to produce the generic drugs in the Netherlands or in Europe in a cheap but still profitable way. A possible solution for this is a modular factory where smaller batches of drugs can also be made at acceptable costs and with a reasonable profit margin,' he says. Lenstra expects that in a highly automated modular factory, it will be possible to set up changeover times and the associated cleaning more efficiently. Without compromising quality and product safety. 'That ensures cost savings.'
The goal is to be able to produce generic drugs in the Netherlands or in Europe in a low-cost, yet profitable way.
Gerard Lenstra Project Manager Internationalization NOM
Opportunities for the North
The plans for a new pharmaceutical plant in the north of the Netherlands are being brought into the Nij Begun program. This program should provide a new start for Groningen and North Drenthe after the problems surrounding gas extraction. In this context, the region has also participated in a growth fund application, PharmaNL. Here the goal is to strengthen pharmaceutical development and production in the Netherlands and Western Europe. Oldenziel: "We see that the government is working to preserve the infrastructure for drug production in the Netherlands. I think that is an important step when it comes to strategic autonomy.'
Unique in the Netherlands
Ofichem is the only Dutch company that produces both raw materials for medicines and the medicines themselves (at two sites). It also engages in drug development and trade. "This way we are active in the whole chain, which is a unique position," Oldenziel says. Trained as a pharmacist, he received his doctorate in neurochemistry from the University of Groningen (RUG) and joined the company shortly after his father died suddenly.
The Ofichem Group now includes seven companies. One is a production company of generic medicines. Another three trading companies and two development companies, one of raw materials for medicines and one of medicines themselves. Since three years, Ofichem has acquired a production company for generic drugs in Leiden.
From family business to integrated player
Ofichem began as a small production company of active pharmaceutical ingredient (API) drugs and has experienced much of the global development. 'In the beginning, we were a supplier in the pharmaceutical chain. We sold the ingredients to companies that eventually turned them into a complete drug,' Oldenziel says. At the end of the last century, the European API industry ran into problems. 'More and more raw materials were imported from China and eventually, at the beginning of this century, about 80% of world production came from there. In recent years this has only increased even more.'
That had major implications for API production companies in Europe, of which Ofichem was one. Meanwhile, Oldenziel became a director of the company and focused more and more on trading drug raw materials. 'We imported the raw materials from China and exported it around the rest of the world. The money we made from that, we invested in modernizing the manufacturing company. We made the turn there from producing APIs for the generic industry to developing and producing APIs for the innovative industry.'
The disappearing ecosystem
Ofichem found a way into the new market, and importing medicines from China brought prices down. 'In the beginning - a few decades ago - that was good too, because medicines were very expensive. But about 10 years ago we went through the zero boundary,' Oldenziel looks back. 'More and more European companies are closing or taking products off the market. Twice as many products go off the market as enter the market. In the end, there are about five players left worldwide, and they are all outside Europe. This means that we cannot intervene quickly here when problems arise, such as geopolitical tensions, a pandemic or a ship blocking the Suez Canal, as we experienced a few years ago. Lenstra adds, "The Netherlands is also often at the bottom of suppliers' priority lists because we have a policy that always opts for the lowest price. Therefore, it is often more lucrative for suppliers to supply other countries first. When there is a shortage, the Netherlands is therefore often at the back of the queue.'
Bringing production back to Europe
Oldenziel sees one solution: bringing some of the production of crucial generic drugs back to Europe. He wants to contribute to that. The entrepreneur sees that governments were made to think during the COVID period. 'France has taken action and started producing generic drugs again partly domestically. The rest of Europe is talking about it, but doing little so far,' he states. Oldenziel believes that the government, both at the national and European levels, needs to establish firm policies and a clear vision. That is easier said than done. Production in Europe is more expensive than in Asia. 'In India, factory employees do not always have the right conditions when it comes to healthcare and pensions. Environmental policies will also be different than here in Europe,' he states.
A plan
Yet Oldenziel does not see price as a problem. 'In the total healthcare budget of 108 billion in the Netherlands last year, 80% of all drugs dispensed cost around 600 million. So this is 0.5% of the budget. For a few cents more per box, you can also produce in Europe. So financially, we are talking about negligible amounts in the healthcare budget. While we are making a choice between dependence or more independence from China and India. Between having or not having access to crucial, life-saving critical medicines. Between having or not having the ability to manufacture our own. We really don't have to make everything ourselves, we have to rebalance between procurement and in-house production.'
But this will not be settled overnight. Oldenziel: 'We need to get started with a clear vision and a plan. I would like to contribute to that.' Lenstra also sees opportunities and is happy with entrepreneurs like Oldenziel in his region and would like to support them from the NOM: 'Policy makers can come up with all kinds of ideas, but ultimately the entrepreneurs have to do it.'