New EFPIA president Higgins targets parallel imports

The European Federation of Pharmaceutical Industries and Associations (EFPIA) will push for a crackdown on parallel imports, said Bayer Schering ceo Arthur Higgins as he took over as president at the end of May.

Higgins, who succeeds Roche CEO Franz Humer, said provision of better health information to patients, innovation and easier access to drugs would also mark his two-year presidency.

Promising continuity but more focus, Higgins said his overriding priority was achievable goals. 'We want to fight battles we can make progress on,' he said. He summed up his four-pronged strategy by the acronym AIMS - access, innovation, mobilisation and security.

Higgins, who started his career with Bristol-Myers and has also worked for Sandoz, Fisons and Abbott, identified lack of trust as one of the biggest single obstacles to overcome if the industry was to make progress on any of the four goals. 'There is not enough trust among the various stakeholders in respect to the industry and on occasions, among the companies,' he said.

Under the banner of security, Higgins said that his goal was to put in place a system to facilitate the tracing of products to counteract the growing risk of counterfeits and address the safety concerns of re-packaging. 'You can't have your healthcare system and drug supply system completely open,' he said.

Criticising 'significant access delays' and 'over-complex regulatory systems' in Europe, Higgins said one of his main goals was to reach consensus on sound health technology methodologies that were acceptable to the industry. 'We fully endorse the requirement but we want more transparency and more consistency,' he said. 'We are trying to work towards common standards.

'What we are not in favour of is a single market approach. We don't believe member states are going to allow Europe to determine drug prices so we would prefer to try to work proactively to establish standards, share best practices and leave individual countries to determine how they acquire them.'

Besides reducing administrative delays between pre and post marketing authorisation and removing government controls for medicines which are not reimbursed, Higgins said the priority was balancing the need to minimise risk with that of fast access to patients to innovative products.

'For 21st century medicines, we need a 21st century regulatory system and a 21st century surveillance system and that's what we are going to try to fight for. We are not going to address safety by increasing clinical studies from 5,000 to 10,000 patients. As an industry we would like to see more accelerated approvals and more stringent risk management and surveillance post launch.'

When it comes to mobilisation, he said one goal was to seek liberalisation of the current framework for providing health information to patients. 'It is not about direct-to-consumer advertising,' said Higgins. 'What we want is empowered patients who have access to non-promotional information.'

He said there was an urgent need to create more forums where regulators, patients and physicians meet. 'Let's have a debate on a modern healthcare system that involves new ways to develop medicines, reimburse medicines, and new involvement [particularly in terms of co-payments] from the patient.'

Under the banner of innovation the key task will be the launch and implementation of the Innovative Medicines Initiative (IMI), said Higgins. The IMI, which is aiming to eliminate some of the bottlenecks to drug development, is funded by the European Commission's Seventh Framework Programme. The EC will contribute Euro 1bn for the period 2007-13. This amount will be matched by the pharmaceutical industry in kind.

'Under my presidency, I want to encourage more shareholder debate and more importantly, develop concrete proposals on how we create 21st century healthcare systems,' said Higgins.