EFPIA, the voice of the pharmaceutical industry in Europe, acknowledged publication of today’s final European Commission report into the pharmaceutical sector. It demonstrated a welcome shift away from the emotive language of the interim report, with a better balanced, more holistic view of the issues facing the sector. The final report identifies the numerous regulatory obstacles that need to be addressed to achieve more efficient innovative and off-patent pharmaceutical markets to the benefit of consumers and patients.

“We have stated consistently that complex and divergent regulatory barriers are the primary cause of market entry delay for both generic and innovative medicines. We are pleased that the final report recognises this reality;” said Arthur J. Higgins, CEO of Bayer Healthcare and President of EFPIA; “We welcome many of the policy recommendations, such as a more streamlined patent system that reduces costs and increases legal and commercial certainty. We commit to working constructively with the Internal Market Commissioner, Member States, and the European Patent Office to push reforms forward under the Swedish Presidency.”

The final report acknowledges the considerable variations in the speed and impact of generic market entry across Member States. Arthur Higgins added, “What is important is that the Commission uses this report to address the issue of competition in the off-patent market. This is an area that can generate savings which could be reinvested to fund innovative medicines.”

The Commission has recognised that while certain regulatory interventions incentivise rapid generic entry and drive prices lower, others (particularly price caps) can have the opposite effect. In 2008, a scheme in the Netherlands reduced generic prices by more than 80% by promoting price competition and challenging pharmacists’ incentives. This provided annual savings of approximately €25 per citizen, despite being limited to 33 products. By contrast, the potential €3 billion savings that immediate generic entry would have generated in the eight years of the Commission’s interim report represent an annual reduction of only €0.90 per citizen.

In its final version, the report failed to substantiate the initial allegation that patenting strategies dampened innovation1 or delayed generic entry illegitimately. Importantly, the final report does recognize the importance of Europe’s innovative pharmaceutical sector and its very significant R&D efforts. The Commission correctly identifies that the protection of intellectual property rights is of fundamental importance for the pharmaceutical industry and paramount to maintaining Europe’s competitiveness.

1 In 2007 there were record numbers of products in clinical development - almost 4,400 - including 763 for cancer, 224 for cardiovascular diseases, 177 for respiratory diseases and 92 for Alzheimer’s. IMS LifeCycle R&D Focus 2007.

Source
EFPIA

An improved Continuing Professional Development (CPD) recording system is being launched
by the Royal Pharmaceutical Society.

This has been created as a result of feedback received from users of the CPD recording
system, CPD stakeholders, along with the outcomes of the 2007-8 CPD pilot and the
recommendations from research conducted by the Welsh School of Pharmacy.
The new version, named V4 online and 1.4 on paper, aims to simplify how entries are made
and will make the review and feedback process more user-friendly.

Janet Flint, Head of Support Staff Regulation, says; “We are excited to be at the point of
launching the new CPD recording system which is easier to use and fit for the 21st century. We
encourage all pharmacists and pharmacy technicians to use the online version, where
possible, but we have also updated the paper version.”

“CPD is an important aspect of ensuring pharmacists’ and pharmacy technicians’ career skills
are up to date and that they are giving the public the best possible service. This tool should
make the CPD requirement easier to record.”

Pharmacists and pharmacy technicians will be able to access the new online recording system
by visiting http://www.uptodate.org.uk

The CPD background material, case studies and answers to frequently-asked questions have
also been updated and may be accessed via the CPD website.
The version 1.4 CPD paper packs can be ordered by calling the pack request line on: 020
7572 2514.

Source
Royal Pharmaceutical Society of Great Britain

People who have superior language skills early in life may be less likely to develop Alzheimer’s disease decades later, despite having the hallmark signs of the disease, according to research published in the July 9, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology.

“A puzzling feature of Alzheimer’s disease is how it affects people differently,” said study author Juan C. Troncoso, MD, with Johns Hopkins University in Baltimore. “One person who has severe plaques and tangles, the telling signs of Alzheimer’s disease in their brains, may show no symptoms affecting their memory. Another person with those same types of plaques and tangles in the same areas of the brain might end up with a full-blown case of Alzheimer’s disease. We looked at how language ability might affect the onset of symptoms.”

Researchers examined the brains of 38 Catholic nuns after death. The participants were part of the Nun Study, an ongoing clinical study of Catholic sisters of the School Sisters of Notre Dame congregation living in the United States. Scientists determined two groups: women with memory problems and Alzheimer’s disease hallmarks in the brain and women with normal memory with or without signs of Alzheimer’s disease in the brain.

The researchers analyzed essays that 14 participants wrote as they entered the convent in their late teens or early 20’s. They studied the average number of ideas expressed for every 10 words. The analysis also measured how complex the grammar was in each essay.

The study found that language scores were 20 percent higher in the women without memory problems compared to those with memory problems. The grammar score, however, did not show any difference between the two groups.

“Despite the small number of participants in this portion of the study, the finding is a fascinating one,” Troncoso said. “Our results show that an intellectual ability test in the early 20s may predict the likelihood of remaining cognitively normal five or six decades later, even in the presence of a large amount of Alzheimer’s disease pathology.”

The study also measured how growth in brain cells might be part of the brain cell’s early response to Alzheimer’s disease or how these cells may prevent memory impairment despite a large amount of Alzheimer’s disease lesions. The study found significant increases in the size of brain cells in nuns with normal thinking skills and Alzheimer’s disease hallmarks compared to people with memory problems and those with normal thinking skills and without the signs of Alzheimer’s disease.

“Perhaps mental abilities at age 20 are indicative of a brain that will be better able to cope with diseases later in life,” said Troncoso.

The study was supported by the Johns Hopkins University Alzheimer’s Disease Research Center, the National Institutes of Health, the Nun Study, the National Institute on Aging, the University of Kentucky Alzheimer’s Disease Center, the Abercrombie Foundation and the Kleberg Foundation.

The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as epilepsy, dystonia, migraine, Huntington’s disease, and dementia.

Source: American Academy of Neurology (AAN)