Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest, which should make the processes in these two areas more efficient. 

In particular, the new policy on access to documents takes into account recommendations made by the European Ombudsman, which earlier this year 

 when the agency refused to grant public access to reports on adverse drug reactions. The new policy sets out how the EMA will proactively disclose such documents in the future. However, some documents or part of them may, however, have to be redacted prior to disclosure to protect confidential data, but the EMA believes the policy will “ensure the widest possible access to EMA documents”, according to a 

Although the policy is still being finalized, it is expected to be published at the beginning of November.

With regards to the handling of conflicts of interest, the EMA’s new policy will help ensure that scientific committee members and experts participating in EMA activities, including meetings and inspections, have no interest in the pharma industry. The policy is due to be published next week. 

“The new policy addresses experience with the handling of conflicts of interests gained since the establishment of the Agency in 1995 and the initial policy set up in 2004,” said the EMA. “It also answers demands for the Agency to strengthen its handling of conflicts of interests, whilst ensuring that the best scientific expertise is involved in the assessment process”.

The new policies were adopted at the EMA’s 68th meeting, where the EMA also delivered a mid-year report for 2010. According to the EMA, the majority of activities are on target, although the rate of submission for initial applications for new and generic medicines has been slow so far. 

Articles

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest, which should make the processes in these two areas more efficient.

EMA adopts new document access policy

 for its transparency when the agency refused to grant public access to reports on adverse drug reactions. The new policy defines how  EMA will proactively disclose such documents in the future. Some documents or part of them may, however, have to be redacted prior to disclosure to protect confidential data, but  EMA believes the policy will “ensure the widest possible access to EMA documents,” according to a 

Although the policy is still being finalized, it is expected to be published in early November.

With regard to the handling of conflicts of interest,  EMA’s new policy will help ensure that scientific committee members and experts participating in EMA activities, including meetings and inspections, have no interests in the pharmaceutical industry. The policy is due to be published next week. 

“The new policy addresses experience with the handling of conflicts of interests gained since the establishment of the Agency in 1995 and the initial policy set up in 2004,” said  EMA. “It also answers demands for the Agency to strengthen its handling of conflicts of interests, whilst ensuring that the best scientific expertise is involved in the assessment process.”

The new policies were adopted at the EMA’s 68th meeting, where  EMA also delivered a midyear report for 2010. According to  EMA, the majority of activities are on target, although the rate of submission for initial applications for new and generic medicines has been slow thus far.   


The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest

EMA Adopts New Document-Access Policy

Following the low growth of the global pharmaceutical market in 2010, IMS Health’s new report, 

, predicts that the industry will rebound somewhat in 2011, growing at a rate of 5–7%, compared with only 4–5% in 2010, to reach $880 billion. 

However, it’s not all good news as the underlying constraints to growth, such as the impact of patent expiries and government initiatives to limit drug spending, will be stronger than ever in 2011.

“In 2011, products with sales of more than $30 billion are expected to face the prospect of generic competition in the major developed markets,” explains an IMS  

. “In the US alone, Lipitor, Plavix, Zyprexa, and Levaquin-which together accounted for more than 93 million prescriptions dispensed in the past 12 months and generated over $17 billion in total sales-likely will lose market exclusivity.”

Data also paint an uncertain picture for 2012-as this is when patent expiries and the shift to lower-cost generic alternatives will have their full impact because of the timing and expected competitive intensity among generic entrants. 

2011 and beyond will also see industry coming to terms with reductions in the drug budgets of public and private payers. “Multiple markets will be impacted by these measures in 2011,” said IMS. “Prominent examples include substantial reductions in the price of generics relative to their branded counterparts in Spain and in Canada, where generic pharmacy rebates are expected to be eliminated; new price negotiation requirements for brands launched in Germany; and across-the-board price cuts for branded products in Turkey and Greece.”

Although the future of the developed pharmaceutical markets may still be a little unsteady, it’s a different story for pharmerging countries, which are forecast to grow at a rate of 15–17% in 2011 to reach up to $180 billion. Many of these markets are benefiting from greater government spending on healthcare, as well as greater demand and access to medicines. In particular, China, which is now the world’s third-largest pharmaceutical market, is expected to grow by 25–27% to reach more than $50 billion next year.

In comparison, the predicted growth for developed markets is much lower. Japan is expected to grow 5–7% in 2011 as biennial price cuts are expected to have little impact, but the five major European markets (Germany, France, Italy, Spain, and the UK) will collectively grow at a rate of only 1–3%. Meanwhile, the US is forecast to experience 3–5% growth. 

So where does industry go from here? Particularly, the developed markets that seem to have tough times ahead? According to IMS, there is a “promising wave of innovation” and potential for several significant treatment options for stroke prevention, breast cancer, and hepatitis C, among others. Five potential blockbuster products are also expected to be approved and launched globally by the end of next year.

“In 2011, we will see the loss of exclusivity for some iconic brands and a promising new wave of innovation,” Murray Aitken, IMS senior vice-president, said in the press statement. “It also will be a critical year for gauging how healthcare reform initiatives in key markets evolve and play out amid the expected macroeconomic recovery. For pharmaceutical manufacturers, an unrelenting focus on bringing distinct value to patients and health systems will be essential to navigating this dynamic market.”

Following the low growth of the global pharmaceutical market in 2010, IMS Health's IMS Market Prognosis now expects the industry to rebound somewhat in 2011, growing at a rate of 5-7%, compared with only 4-5% in 2010, to reach $880 billion.

IMS Health Says Global Pharma Market Will Rebound in 2011

It’s been a busy few weeks at the European Medicines Agency (EMA), with a number of marketing authorization suspensions and safety reviews launched, including a thorough review of all bisphosphonate-containing medicines following a possible increased risk of atypical stress fractures. Last week’s 

 of the EMA’s Committee for Medicinal Products for Human Use (CHMP) outlined some of the key decisions made by the agency in recent weeks.

Last week, the EMA recommended suspension of GlaxoSmithKline’s rosiglitazone-containing medicines Avandia, Avaglim and Avandamet (discussed in a recent 

) because of studies questioning their cardiovascular safety. Additionally, the EMA recommended suspension of Octapharma’s Octagam — as well as a recall of all Octagam currently on the European market — following an increase in thromboembolic reactions, including stroke, myocardial infarction and pulmonary embolism. According to a 

 from the EMA, the issues are thought to be related to problems with the medicine’s manufacturing process. 

A number of other medicines are also under close scrutiny from the EMA because of possible safety-related issues. Recently, Sanofi Pasteur’s oral rotavirus vaccine RotaTeq was subjected to a safety review following the detection of porcine circovirus DNA fragments; however, the CHMP concluded that the vaccine does not present a risk to public health and continues to have a positive benefit-risk balance. 

There is also an ongoing safety review of GlaxoSmithKline’s Pandemrix pandemic influenza vaccine after 

 a possible link with narcolepsy. According to the EMA, there is currently insufficient evidence to substantiate this and further studies will be required. For the moment, however, the vaccine’s benefit-risk balance continues to be positive, with no restrictions issued for use. 

At its latest meeting (held 20–23 September), the CHMP also announced the initiation of a review of bisphosphonate-containing medicines looking at the possible increased risk of atypical stress fractures. The CHMP has said it will thoroughly review all available data to clarify whether atypical stress fractures are a class effect of these medicines and whether this will impact the risk-benefit balance.

Additionally, the CHMP has also announced a review of the benefits and risks of Avastin following the results of a study conducted by Roche. The study was submitted in support of an application of Avastin in the treatment of breast cancer in combination with certain forms of chemotherapy. However, according to the CHMP, in comparison to results of previous studies, “this study points to inconsistencies between different trials relevant for the currently approved breast cancer indication, particularly in terms of efficacy”. The review of Avastin will assess the new data and their impact on the benefit-risk balance of the medicine.

As well as news regarding marketing authorization suspensions and drug safety reviews, the CHMP also announced several new product approvals at its September meeting. Novartis’s Aflunov and Prepandemic influenza vaccine (H5N1) has been approved, as well as Novartis Europharm’s orphan medicine TOBI Podhaler, which is intended to suppress chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis. AstraZeneca’s Brilique and Possia also received a positive opinion for preventing atherothrombotic events in adult patients with acute coronary syndromes.

It was also announced that Merck Serono’s Movectro, intended for the treatment of multiple sclerosis, had received a negative opinion from the CHMP even though the same treatment has been approved in Australia. 

 released by the EMA on 20 September, the agency has so far issued 28 positive opinions this year for medicinal products and one negative opinion.

It?s been a busy few weeks at the European Medicines Agency (EMA), with a number of marketing authorization suspensions and safety reviews launched, including a thorough review of all bisphosphonate-containing medicines following a possible increased risk of atypical stress fractures.

Suspensions and safety reviews from the EMA

Pharma companies must ensure that patients have access to “objective, unbiased information” about medicines, according to MEPs of the European Parliament’s Health Committee  this should be a patient right rather than an option for pharma companies.

This issue was raised earlier this week when MEPs voted on the element of the EC’s 2008 ‘

’ concerning improving patient access to health and medicines information. The basic aim of the draft legislation is to ensure that good quality and reliable medicines information is available. In the draft proposal issued by the EC, pharma companies would have had the 

 of making available unbiased medicines information.

, however, MEPs introduced a new article into the legislation that would 

 pharma companies to make available the most recent summaries of product characteristics and labeling and package leaflet, as well as a publicly accessible version of the assessment report. Companies would also have to state which diseases and health conditions can be treated with the medicine and provide information on how to prevent these. Member states would also be obliged to ensure that information is available to the general public on all medicinal products sold within their respective borders.

In addition, pharma companies would also have the option of providing public access to other “well-defined non-promotional information” such as the environmental impact of the product, or instructions for use (which would require prior authorisation from the competent authorities).

The information would have to be supplied in both electronic and printed form, as well as in formats for the blind and partially-sighted. However, companies would not be allowed to disseminate information 

 radio or television broadcast. Printed material would only be sent to members of the public at their specific request and would not be published in newspapers or magazines.

The vote has been noted by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which commended the European Parliament for its “pragmatic approach” to the proposals in a 

. The suggestion of disseminating medicines’ information to patients has caused controversy in a number of member states, with some reluctant to even discuss the issue. However, “such an approach ignores the reality of the modern information society, and perpetuates inequalities of access to information that currently exists between member states”, according to Brian Ager, Director General of EFPIA.

EFPIA believes that the vote is a step in the right direction, but also warns that to be effective any new legislation must also provide a viable legal framework. “It should build on existing best practice within the EU, and not introduce costly and unnecessary bureaucracy, delivering neither real benefit in the quality of information nor public health gains,” warned Ager.

EFPIA says it has already made “concrete” proposals for a reform of the current situation, including a set of quality criteria to distinguish information from advertising along with a Europe-wide code of practice.

Pharma companies must ensure that patients have access to "objective, unbiased information" about medicines, according to MEPs of the European Parliament?s Health Committee &#151; this should be a patient right rather than an option for pharma companies.

Pharma companies must be more transparent

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The rule requires that certain safety information, which was previously not required to be reported to the FDA, must be reported within 15 days of becoming aware of an occurrence. These reports include:

findings from clinical or epidemiological studies that suggest a significant risk to study participants

serious suspected adverse reactions that occur at a rate higher than expected

serious adverse events from bioavailability studies, as well as bioequivalence studies in the case of generic drugs.

 for industry and investigators that provides information and advice about the new requirements.

“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” Rachel Behrman, Associate Director for Medical Policy in the FDA’s Center for Drug Evaluation and Research, explained in a 

. “These changes will better protect people who are enrolled in clinical trials.”

The rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under the current regulations, drug sponsors often report all serious adverse events, including those that are probably not related to the product. This reporting can complicate and delay the FDA’s ability to detect safety signals. The rule clarifies when a single event should be reported and when sponsors should wait for more than one occurrence. According to the FDA, the new rule also revises definitions and reporting standards to make them more consistent with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences. 

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.