Improved regulatory co-operation through TTIP – benefits for patients, industry and society
09.07.15
There is a lot of white noise with many preconceptions and misconceptions about what the deal will contain and how it will affect people. Against this background there is a real risk that facts are lost and real benefits will be unrealised.
There are numerous social and economic benefits to TTIP but I would like to focus on health. From a healthcare – and certainly a pharmaceutical – perspective, increased regulatory co-operation through TTIP would serve to benefit patients, industry and society, by creating common standards of excellence on quality, safety and efficacy. The result would cut red tape leading to streamlined processes and procedures for faster patient access to new, innovative, life-saving medicines.
There are also significant benefits to be gained by reducing duplicative inspections and redundant testing. A Mutual Recognition Agreement (MRA) on Good Manufacturing Practices (GMP) within the framework of TTIP would, for example, reduce technical barriers on both sides of the Atlantic. This would require equivalent GMP standards to be applied by both parties and would reduce the need for duplicative inspections by 40%. This would not only enhance regulatory authority efficiency but also save money for everybody.
An operational MRA would also mean that Qualified Persons, whose job it is to certify imported medicines batches, could rely on the certification of the other TTIP partner – again, saving time and resources. Many new medicines continue to be developed through research collaborations between academic institutions and smaller enterprises. By cutting the costs created by duplicated site inspections, SME’s would be able to invest these much-needed returns back into research.
TTIP also has the crucial potential to create a more harmonised approach to clinical trials in children. While both the EU and US retain high regulatory standards for the development of paediatric medicines, their approaches remain quite different. By establishing common procedures and timeframes for submitting paediatric plans through TTIP, we can reduce unnecessary and duplicative testing on children and accelerate the delivery of new paediatric medicines.
Apart from the benefits to patients and industry that TTIP can bring, the potential economic benefits of TTIP should not be sidelined – far from it.
Time and again the economic benefits of TTIP have been emphasized and there are obvious reasons why: the potential economic gain for the EU would be in the region of €120 billion; for the US it would amount to some €95 billion.
Closer regulatory co-operation between the EU and the US through TTIP could therefore present the opportunity for economic gains, reduction of red tape and result in significant improvement in the overall environment for research and innovation in the field pharmaceuticals. As the tenth round commences next week, the pharmaceutical industry remains committed to an ambitious TTIP agreement which will create high standards of regulatory excellence, resulting in improved healthcare and enhanced patient access to innovative medicines on both sides of the Atlantic.
