Representatives from European patients’ organisations, academia, science and industry have urged Europe’s decision-makers to approve the common framework for advanced therapies – treatments made from cells, genes or tissue engineering – at a dinner debate organised by the European Platform for Patients’ Organisations, Science and Industry (EPPOSI) and hosted by Avril Doyle, Member of the European Parliament.
“Advanced therapies have the potential to revolutionise the way that patients are treated and, in many cases, offer treatments where none existed previously,” explained Avril Doyle. “This Regulation is the key to getting those products out of the laboratories and making sure that they are safely available to patients,” she confirmed. Currently, each individual Member State of the EU regulates these products differently. In some countries, they are not regulated at all, meaning that patients cannot be sure of the safety of products that they might be receiving. Therefore, patients urged that all products should be subject to the evaluation. “It is unacceptable that some products are left in the unregulated grey zone,” explained Alastair Kent, president of EGAN, the European Genetic Alliances Network. “Delaying the approval of the Regulation, or excluding some products from this Regulation will prevent some patients having access to them. But worse, those that do get them will have no guarantee of their safety.”
And for the life sciences sector, the bewildering patchwork of rules and regulations means that each product must be registered country by country. Evidence must be gathered and formatted according to each individual system, so that patients in one country can receive the treatment long before those in another. The new EU Regulation would solve all of this by putting in place a single EU evaluation – similar to that currently required for normal medicines – that would allow patients all over the EU assurances of safe, efficacious and high-quality products all at the same time.
The draft, endorsed by the European Parliament’s own Environment Committee which has primary responsibility for the draft legislation, calls for all products to be evaluated to the same standards, but leaves it up to individual member states to accept the product in its market or not. “This is the same approach as that taken with contraceptive products, where views differ from one country to another,” continued Alastair Kent. “This Regulation is particularly important for those who suffer from incurable, often genetic diseases,” explained Flaminia Macchia, speaking on behalf of EURORDIS, the European Organisation for Rare Diseases. “Millions of patients are waiting for the fruits of new research and this Regulation will open up that possibility,” she added.
