Monthly Archives: February 2013

February 28, 2013 | By Márcio Barra

The Indian Department of Pharmaceuticals has issued a new draft policy that might be a bit (and just a bit) of good news for pharma companies struggling with the country compulsory license agreements, a clause under the Trade Related Intellectual Property Rights. These agreements saw drugs patents being rendered meaningless, in favor of licenses to generic drug makers when the Indian Government deems that the price of a drug is beyond the reach of the patients. Bayer’s kidney cancer drug Nexavar is a good example, a $5,000 a month drug that was licensed to Natco Pharma, and Indian generic drug maker who began selling the drug for $170 a month, and later Cipla, who sells it at $130 a month.

This new draft policy is for price negotiation for patented drugs and price regulation by the Indian government. In essence, it states that a patented drug can have its price regulated by a government appointed Committee, and once regulated, the provision to issue that drug a compulsory license on the basis of it being too expensive will no longer be possible.

In short, the draft policy goes on to say that if a government appointed Committee regulates the price of a patented medicine, and gives it a price that the Indian Government deems acceptable, no Compulsory License can be issued. The pricing formula would take into account the per-capita income of Indians, and the prices paid by governments in the U.K., Canada, France, Australia and New Zealand are to be used for reference. However, a Compulsory License can still be issued on other grounds apart from price, like for example drug shortages.

Now, while this might seem like good news for Pharma companies who are seeing their patents rejected, it’s still far from a satisfactory conclusion for them. If the policy is implemented, it could lead to multinational drug companies being forced to sell their drugs at a third of their current prices. Price control is already in place in India for 348 generic medicines, but this is the first time that patented drugs could be affected as well.

However, it isn’t clear when this could happen. Seeing as the panel took six years just to come up with the draft, it could be a while before price regulation starts hitting patented drugs in India.

Drug price control has been a topic of debate in India. The authorities argue that price controls are necessary to ensure that expensive drugs are available at affordable rates to the poor. This is surprising move from Indian government to try and relieve the burden of drug expenditure costs of the Indian population. It’s worth noting that Indians pay almost 70% of health-care expenses out of their own pockets, and most of this spending is on medicines. And the general awareness is that the Indian Government cares little for their populace wellbeing.

India, with a population of more than 1 billion, has the highest number of sick people in the world for any disease, due to the extreme poverty of the population. But Central and State governments don’t even acknowledge more than 20% of the diseased.

Adding up to all this, the health sector in India is dominated by an unregulated private sector, as the Government neglected the Health Ministry and subsequently, the public health sector.

The question remains if the Indian population, even after price regulation hits, will be able to start affording medicines.

The report is out for comment until March 31.


Fierce Pharma

First Post

The Economist Times

February 27, 2013 | By Márcio Barra

From the news here at Portugal, I assumed that drug shortages were a mostly Portugal-centric affair, caused by parallel import (as Portugal has one of the lowest drug prices in Europe) and the severe debt crisis. However, from the few articles I’ve read here and there, this issue is threatening the whole EU, not because of parallel import situations (these are affecting mostly countries with reference pricing systems), but mostly of underfunded health systems and of the passing of the new falsified medicines directive (2011/62/EU) back in January, amongst other issues. This directive states that only countries that are part of a GMP compliant list (dubbed the white list) can import actives and other substances to Europe. India, China, America and Japan don’t subscribe to the white list, a rather dire situation seeing as most actives are sourced from these countries.

Now, the European association oh Hospital Pharmacists (EAHP) published in February 21 results of a recent survey conducted in over 300 respondents from 27 countries, where it shows that 99% of the questioned hospital pharmacists experienced medicines shortages in 2012. The survey also uncovered that 63% of hospital pharmacists report medicines shortages to be a weekly, sometimes daily, occurrence.

On this topic, please stay tuned for my article on drug shortages in Portugal! 


European association oh Hospital Pharmacists


Regulatory focus 

February 25, 2013 | By Márcio Barra

Good news for people, like me, who are or might be allergic to cats’ fur. Today, Circassia Ltd, an allergy focused biotech, announced the results of a phase II study for their new ToleroMune® cat allergy therapy, a vacine comprised of seven peptides derived from  Fel d 1, that quiets the T-cells reaction. And the results are promising for anyone who suffers allergic reactions to cats.

The phase II, parallel study conducted in 202 patients initially measured improvements in nasal and ocular allergy symptoms after treatment with ToleroMune® therapy or placebo. Then, two years after, and having received no further ToleroMune® treatment, 50 patients were called to be reevaluated after 4 days of exporsure to cat allergens. The results showed a 50.0% improvement on the Total Rhinoconjunctivitis Sympton Score (TRSS) vs 14.9% on placebo after exposure to the cat allergens, and a 38.3% TRSS improvement vs 13.4% on placebo during the four day cat allergen challenge. Overall symptoms were also reduced during the two years of no therapy.

ToleroMune® is currently being tested in phase III trials.

Read more at:



February 22, 2013 | By Márcio Barra

This just in, today the FDA approved Kadcyla (ado-trastuzumab emtansine, or T-DM1), from Roche/Genentech. Kadcyla is a therapy for patients with HER2-positive, late-stage (metastatic) breast cancer, and it consists of an antibody, trastuzumab, connected to a drug called DM1.

HER2 is a protein encoded by ERBB2, a proto-oncogene located in chromosome 17. Over-expression of this proto-oncogene occurs in roughly 30% of breast cancers, and the increased amount of HER2 protein contributes to the breast cancer cell growth and survival.

The way Kadcycla works is quite novel. The antibody, trastuzumab, is linked to the chemotherapy agent, DM1 (or mertansine) through a stable linker. The antibody essentially delivers the chemotherapy agent directly to the cell growth protein HER2.

As it was designed for late-stage breast cancer, this drug is only intended for HER-2 positive patients that have not responded to trastuzumab or chemotherapy alone. Clinical trials show that patients survived a median of 30.9 months, as opposed to 25.1 months with the alternative treatment, lapatinib plus capecitabine.

This drug was approved under the FDA’s priority review program, a six month review process for drugs that provide safety and effective therapy when no other therapy exists, or offers a significant improvement compared to already existing products in the market.


Bloomberg (FDA press release)

February 19, 2013 | By Márcio Barra

Today, Paulo Macedo, the Portuguese health minister, in the II TSF AbbVIE conference, announced his intent in further decreasing drug expenditure, as to decrease the rising costs of diabetes care.  These comments were prompted by the release of the National diabetes observatory annual report, regarding the year 2011, where it shows that the costs with diabetes continue to increase in Portugal, currently representing an expense of 1816 million euros, or 1% of the GDP. In the last decade, insulin packages increased 60%, and the cost of these packages increased 297,5%.

To counter these increases, Paulo Macedo announced a centralized tender, under the shared services of the Ministry of Health, aiming to decrease the prices of glucometers. The minister also expressed his wish of decreasing the costs of diabetes medication, and the necessity of earlier diagnosis of diabetes patients. Of the more than 1 million diabetic patients in Portugal, 44% is not diagnosed. Late diagnosis can lead to complications and amputations, which increase hospital costs. This is especially noteworthy when you consider that hospital costs are more than double than medication costs.



February 18, 2013 | By Márcio Barra


It looks like, while I was away, that some new changes occured in the Portuguese regulatory landscape. The law that governs medicinal products in Portugal – the Estatuto do Medicamento, or Decree-law nº 176/2006 – underwent its seventh revision, published last Wednesday in the Diário da República, and entered into force last Friday.

The revision, upheld by Decree-law n.º 20/2013, was prompted by the new European pharmacovigilance directive, which brought a lot of changes on how Member States should conduct their pharmacovigilance activities. The new revision took the feedback from major Portuguese stakeholders and players in the pharmaceutical industry, such as the order of pharmacists, order of physicians, order of nurses, the Portuguese pharmaceutical industry association, the generic drug association, amongst others. Here are the main changes:

  • New definitions and clarifications on previous definitions: Mostly concerned with the new changes brought forth by the new European pharmacogivilance directive, such as the new adverse reaction definition, risk management systems, and post authorization studies. Homepathic drugs are also further explained.
  • Earnings transparency: This is the biggest change.  All agents of the health sector, be it physicians, scientific societies, patient associations, etc. are now obliged to publicly declare to Infarmed (the portuguese competent authority on human drugs), in a period of 30 days, all financial support, either direct or indirect, provided by the pharmaceutical industry. Failing to do so may carry fines from 2.000 to 3.750 euros if it’s an individual, or up to 45.000 euros if it’s a group of people.  These details have to be sent to Infarmed through the Comunication Platform (through here), and all this information will be published online.
  • More power to Infarmed: Infarmed may now, after giving a market authorization to a drug, request the market authorization holder to conduct a post marketing study, whenever there are concerns about the pharmaceutical product. After a request, the markething authorization holder has to present to Infarmed a project for a clinical trial protocol. Based on the results of the trial, Infarmed conducts proper action.

Infarmed can also, besides regular fines, enforce further, “accessory” penalties whenever the situation and the offender warrants. These accessory penalties include:

The loss of objects, equipment and devices to the State;
Suspension of all activities for a maximum of two years;
Denial up to two years of the right to participate in public contracts;
The suspension of any market authorization or other rights for a maximum of two years.
The Decree-law also states that a national drug portal, managed by Infarmed and connected to the European drug portal will be created. In this website, Infarmed will publish, among other things, each portuguese SmPC, reports of public evaluations, summaries of the risk management plans for authorized drugs and information on the different ways available both to health professionals and patients to report adverse reactions.

  • Markething authorizations: All requests for a MA now have to be accompanied by a summary of the proposed pharmacovigilance system, alongside a suitable risk management plan and the schedule of the Periodic Safety Reports (PSUR). All holders of MA’s granted before July 21, 2012 are exempted from applying said system, unless Infarmed so demands.

Seems like busy days are ahead for the Portuguese competent authority. More new jobs maybe?


Decreto-Lei n.º 20/2013

February 15, 2013 | By Márcio Barra

Slow updates this weekend, as I’m currently attending the Regulatory Affairs Module of the Training Programme in Pharmaceutical Medicine, at Infarmed, Lisbon. It’s been fascinating so far, with a special presentation by Bruno Sepodes, chairman of the EMA’s COMP on Orphan drugs. I hope to bring more content and ideas to write as soon as it ends!