Regulatory agencies need to be more proactive in preparing for avant-garde products.
The London-based European Medicines Agency (EMEA), the body in charge of regulating the marketing of pharmaceuticals in Europe, is falling well short of its stated goal of stimulating the development of innovative new medicines.
“Publicly funded institutions can no more afford premium fees than small businesses can.”
In particular, the EMEA has stumbled in its dealings with Pharma-Planta, an academia-led consortium funded by the European Commission (EC) to develop drugs for diseases that continue to pose problems in both Europe and the developing world using transgenic plants.
The consortium recently offered to help the EMEA improve regulations for the manufacture of plant-made drugs, so that they would be ready when the first products come to market (see page 951). It also hoped to instil confidence in the wider European drug industry, which has been reluctant to invest in drugs made from transgenic plants despite the technique's promise as an inexpensive drug-production pathway. One reason for this reluctance may be that many Europeans are reluctant to embrace genetically modified crops in general. But a large part of the problem, analysts say, is that the strict controls on manufacturing processes and product quality required to get marketing permission from the EMEA were drawn up for traditional biopharmaceutical production methods, which use engineered microbes and cultured mammalian cells. Those controls needed to be redrafted to fit transgenic plant systems.
Hence the consortium's offer. The EMEA, however, insisted on charging Pharma-Planta its standard rate for scientific advice — €75,500 (US$97,500) — because it had no policy in place to give academic institutions the same 90% discount that it gives small businesses. The EMEA did offer a 50% discount, but even so the consortium had to bow out; it could not afford to work with the agency.
The EMEA should reconsider this position. It is one thing to charge a premium fee to large pharmaceutical companies looking to market a new drug with a huge profit potential. But publicly funded institutions can no more afford those premium fees than small businesses can. Moreover, the Pharma-Planta consortium wasn't trying to market anything; it simply wanted to help the EMEA to develop better regulation and guidelines. The EMEA has now published improved guidelines, albeit with limited input from Pharma-Planta, the leading expert in the field.
The EMEA should also reconsider the process through which it develops its guidelines and regulation. It holds an important and influential position in Europe: the overarching guidelines and regulations it produces filter down and often inform national rules across the continent. The EMEA must be more proactive in developing guidance on up-and-coming technologies — especially on new and controversial ones such as transgenic-plant-derived pharmaceuticals — rather than waiting for others to point out that new rules are needed.