Brussels, 14 November 2012: Richard Bergström, speaking today, said:
“Medicines should benefit patients. We support measures that enhance the way they are used and enable the industry to continue to innovate. These measures include improved transparency. As a global industry, we are focused on working towards responsible transparency, as shown by the commitments already made. Building on these initiatives, we recognise and take seriously our responsibility to lead in advancing transparency, and propose that this needs to be part of a comprehensive initiative involving all stakeholders.”
The European Parliament is about to start discussions regarding Clinical Trials that are vital to get the best quality medicines for patients throughout the European Union. EFPIA strongly supports the efforts done by the European institutions for the work they are undertaking on such an important subject.
We recognise that we have a responsibility to show leadership in advancing transparency and propose that this needs to be part of a comprehensive initiative involving all stakeholders. Medicines should benefit patients, we therefore support measures such as improved transparency that will enhance the way they are used and enable us to continue to innovate in the future. As a global industry, we are committed to responsible transparency, as shown by the commitments that have already been made. For example IFPMA, EFPIA, JPMA and PhRMA and their member companies have committed to registering all clinical trials conducted in patients on a public registry and disclosing the results, positive and negative of industry-sponsored clinical trials in patients, through public databases as detailed in the Joint Position on the Disclosure of Clinical Trial Information.
However, there is a potential for significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way. We believe it is both feasible and necessary to balance the needs of personal privacy and commercial confidentiality while providing the level of transparency needed to support public health decision-making. In relation to access for public health decision-making purposes, we are committed to engage fully in the forthcoming debate and find appropriate solutions. As part of that process, we would like to see further reflection on the timing of disclosure and its implications for the regulatory decision-making process.
For example, many products and new uses are not protected by patents but by regulatory data protection. It would be damaging to companies if competitors could circumvent this by printing all the data from the internet.
We must also not forget to address the other parts of this larger question of Clinical Trials such as development countries and ethics. This is a larger debate than transparency alone and no stakeholder should be left out of the debate. We strongly believe that it is not possible to get the best possible legislation without everyone at the table, to ensure that citizens and patient throughout the EU have the highest quality of medicines possible.
You will find here EFPIA’s dedicated webpage on the issue as well as our key messages and position paper.