Source: Pharmaceutical Technology Europe
Issue 6,Volume 22
When will personalised medicine deliver on its promise? and Europe's IP system trails behind the US
A recent survey has attempted to identify why the deployment of personalised medicine into mainstream medicine is occurring so slowly. With its promise of more effective treatments with fewer side effects, personalised medicine has the potential to be a significant medical development, but there are many barriers hindering development that will require EU action if they are to be resolved.
"That there should be a European dimension is a widely held view," Richard L. Hudson, CEO and Editor of Science|Business, told Pharmaceutical Technology Europe in an exclusive interview. "Our survey, conducted with the Swedish medical university Karolinska Institutet, found that 80% of respondents support EU coordination — a pretty radical view, given that the provision of healthcare is a national, not EC, responsibility."
The survey — a lengthy questionnaire aimed at examining the promise and problems of personalised healthcare — was sent to more than 800 healthcare specialists in Belgium, France, the Netherlands and the UK.
So what are the problems facing the implementation of personalised medicine? A principal issue is cost. Although 46% of survey respondents expect personalised medicine to lower medical costs in the longterm, 38% and 58% believe that it will raise costs in the long- and short-term, respectively.
According to the Science|Business report, The Promise of Personalised Healthcare in Europe, which is based on the survey results, the general picture is that costs will rise before they fall, which is an obvious barrier. "Human nature being what it is, present pain usually gets more attention than future gain," says the report.
"Beyond science, such as the identification of biomarkers and understanding of biology, the biggest barrier is finance," said Hudson. "Seventy eight percent of respondents identified insufficient investment and funding as a significant barrier."
Another issue, which will come as no surprise, is the regulatory system. "More than 60% say the absence of clear regulatory guidelines is causing delay. Not surprisingly, industry executives feel this most strongly, but patient advocates fully agree with them."
Fortunately, initiatives are already taking place at the European Medicines Agency (EMA) that may go some way to aiding the situation. Hudson explained that the EMA has already published guidelines for the development of biomarkers, and is also developing its first guidelines regarding the use of biomarkers in pharmacokinetics.
Although personalised medicine is disrupting traditional healthcare models, Hudson adds: "It's both exciting and scary for the industry — much like the way personal computers and the internet turned the electronics, computing and media industries upside down, creating new winners and losers. Disruptive technologies upset the old order in every industry."
So what must companies do to stand any chance of success in the new order of healthcare? In truth, nobody really knows. "The technical issues will be resolved — that's a challenge well within the capability of the pharmaceutical industries, biomedical researchers and the wider business world to solve, but the real wild card is the public sector," said Hudson. "Even today, for breast cancer treatment, in many European countries Herceptin diagnostics are simply not used by doctors nor reimbursed by the insurers or health services — this is despite years of evidence that tandem diagnostic/drug treatment is vital to the treatment's success," said Hudson.
In the present situation, the advice from Hudson is: "Don't get left behind, but equally don't yet bet the whole company on it."
The full interview with Richard L. Hudson can be read at: www.pharmtech.com/hudson
The US is a better environment for drug innovation than Europe thanks to its intellectual property (IP) system, which is considered by many in the pharmaceutical and biotechnology sectors to be more suited to the industry's needs. The findings come from international intellectual property group Marks & Clerk, which conducted a survey of 381 executives across the pharma and biotech sectors to assess opinions of the European and US regulatory and IP systems.
"Our respondents straightforwardly state that the US IP system has better managed to adapt to industry needs," Paul Chapman, a Partner at Marks & Clerk, explained in a press statement. "Not only does the US provide greater scope for patent extensions — an issue of increasing importance to the industry — but further reform is soon to be enacted that will improve patent quality and limit damages."
The faith in the US system also extended to President Barack Obama's healthcare reforms, with the majority of respondents saying that the reforms would not harm drug innovation in the US. In fact, 89% of respondents believed that the reforms would attract lasting capital back to the US market.
Unfortunately, opinions of the European patent system were not so promising.
The European system has come under intense scrutiny recently following the EC's probe into anti-competitive practices, which found that originator companies were using patents to block or hinder generic entry. Just over half (51%) of survey respondents also agreed that it was fair to say market entry had been improperly delayed and 71% said that EC intervention is likely to lead to earlier market entry of generics.
However, 89% of respondents believed that it is legitimate commercial practice to take full advantage of the patent system. Seventy eight percent of respondents also added that critics of secondary patents do not give sufficient recognition to the role of incremental innovation.
Another criticism respondents had of the current European system was the patent term extension system (supplementary protection certificates), which provides protection only for the precise API indicated in the underlying patent. Seventy nine percent of respondents believed that the system should offer the same scope and protection as that given by a patent, as is the case with the US system.
As well as the ongoing debate regarding secondary patents, another issue survey respondents were concerned about was recent changes to the European patent application process. In April this year, the European Patent Office (EPO) made changes that affected the searches and divisional filings made for patent applications, with the aim of significantly increasing the speed in which patent applications are processed. Although 54% of respondents support the prioritisation of speed, 45% believe that the process should be slower and more thorough, allowing for greater flexibility. The majority of respondents (82%) were also in agreement that the changes would be particularly burdensome for smaller companies with limited resources because the changes would force companies to make important decisions about the future direction of their R&D and patenting strategies at an earlier date.
"The recent changes to Europe's patent application process seem likely to place a disproportionate burden on the very same smaller players the industry is desperately hoping will provide the next generation of medicines," said Chapman. "Europe appears to be moving in the wrong direction. Its patent application process has always suffered from being seen to be more burdensome than its US counterpart, and the recent changes will only make things worse."
2016's pharma top dogs
2016 will see Pfizer continue to cling to first place in the top ten pharma list, but Merck & Co. and Novartis will not be far behind. A few major patent decisions or further mega-mergers could topple the pharma giant from its coveted perch, according to analysis from EvaluatePharma.
Read more at: www.pharmtech.com/2016
EMA to improve
After completing the first phase of a project designed to increase the consistency and transparency of EU regulatory process, the European Medicines Agency (EMA) published a summary report that includes suggestions for improving the current processes for evaluating benefit–risk.
Read more at: www.pharmtech.com/ematoimprove
Preventing cargo theft
The FDA has sent a letter to trade associations of manufacturers, wholesalers and pharmacies recommending procedures for preventing and responding to product thefts. The letter follows recent thefts of prescription and over-the-counter medicines, vaccines and infant formula.
Read more at: www.pharmtech.com/cargotheft
The European Ombudsman has recommended that the EMA review its refusal to grant public access to reports on adverse drug reactions following a complaint from 2008 when it refused to grant access to such documents to an Irish citizen. The EMA claimed that EU transparency rules do not apply to adverse reaction reports.
Read more at: www.pharmtech.com/emacriticised