New Indian PM Narendra Modi
(Image: Flickr/narendramodiofficial)

Given the current national mood that led to the spectacular victory of Mr. Narendra Modi’s Bharatiya Janata Party (BJP), it would only be fair to say that India, and its citizens, want greater equity, quality, transparency, and choice. That is as true of their healthcare needs as it is of everything else.

In the recent past, increasing government expenditure on health (as a % of GDP) and moving towards a system based around Universal Health Coverage (UHC) made big news. While both augur well for India, it is important to realize that they are but the means to an end. For a government with a sweeping mandate, the focus must clearly be on making India a healthy nation, understanding clearly that health has a multiplier effect on the nation’s GDP. Focus on the very basics; focus on health could be a motto.

India’s health needs are paradoxical. At one end, we lose babies and mothers, lives that could be saved easily including large cases of malnutrition.  On the other, our growing urban population is getting older, making unhealthy lifestyle choices, and increasing burden on non-communicable diseases (NCDs). To address both ends of the spectrum, the government has to define its role clearly.

Mr. Modi has on occasion expressed his focus on preventive healthcare – preventing disease rather than treating it. This will involve building capability across the spectrum. In the short-term, we are likely to see an increase in the number of medical and paramedical colleges to train and deploy locally, more hospitals and treatment points-of-care, and provision of financial security to access healthcare. This might either happen through targeted direct cash transfers or reforms in the insurance sector to accord affordable health security to the most under-privileged.

In the medium-term we might expect large-scale programs to address malnourishment, spread awareness of health and screening and proactive treatment of health conditions. While screening and management can be outsourced to the private sector through Public-Private Partnerships (PPPs), prevention and awareness activities must be spearheaded by the government. Innovative solutions can be devised to engage the private sector and other stakeholders, but it must be the government that should drive this. Mr. Modi is a believer in the catalyzing role of technology and he is likely to facilitate its infusion into the healthcare space liberally. Under his leadership the Gujarat government brought down the infant mortality rate significantly with the implementation of ‘eMamta’, a mobile mother-and-child tracking system that has registered over 480 million families.

By creating transparent and accountable systems and speeding up decision-making & implementation, Mr. Modi administered for three straight terms at the state level. This will encourage the newer government departments to shun its traditional style of working, and instead identify and implement priority actions in other sectors like trade, taxation, education, agriculture, urban development, food and pharmaceutical production and allow for substantial health gains, especially for the poor. Easing up tax, labor and infrastructure laws will ease up FDI norms and attract much needed investment into the pharmaceutical sector and kick-start the revival of India as the quality drug manufacturing hub of the world. This revival will also provide a fillip to the free medicines scheme for the poor through the public system and a transparent market-based pricing in the private system.

Mr. Modi’s passion is to transform India into a hub of innovation. He has publicly questioned why top quality medical equipment and medicines cannot be manufactured and exported from India. This vision will create more jobs, reinstate India’s position at the global table and build formidable economic prowess consequently improving diplomatic ties with the global community. This important step will facilitate transfer of much needed cutting-edge technology into R&D while helping to protect against predatory trade agreements that can potentially harm the interests of the average Indian. It can also revive the clinical trials sector globally, by reassuring transnational corporations of India’s capabilities and support, while reinforcing the need for ethics and protecting the interests of its citizens.

The new government must be judged on the basis of its ability to devise innovative solutions that will keep the nation healthy. India does not lack the ability to deliver; we also have the requisite technical experience and knowledge.

I was happy to get this personalized message on twitter, the day results were declared and was happy to  note the powerful vision that it shares with the nation. Surely innovation will be the key, and I hope that the next government will usher in a period of innovative solutions across the spectrum, that can tackle some of India’s health sector challenges head-on.

The post Does the New Government Bode Well for India’s Healthcare Sector? appeared first on GLOBALHealthPR.

The global pharmaceutical industry is experiencing important changes. Among them, the loss of patents to major blockbusters, the arrival of biosimilars and, more importantly, a new scene regarding regulatory issues.  With respect to the latter, Mexico has gone through many changes. We are not the only ones; it’s something we’re seeing in many countries around the world. Because of this, strategic creativity and a renewed focus communication campaigns have become a must.

Mexico is the second-largest pharmaceutical market in Latin America, with a 15% share of the region and an estimated value of $190 billion pesos ($14.8 billion USD) in 2011. The picture in the pharmaceutical sector in the region is encouraging, as expected sales in Latam are expected to surpass the $1.2 billion mark in 2016.

According to IMS Health, 40% of the Mexican pharmaceutical market is led by the brand-name innovations from private-sector firms, verus 18% from government-owned institutions. However, generics account for a 42% share currently. This “generics revolution” is going strong and increasing significantly. Newly-approved generics, which offer an average per-product savings of 60%-90 on average to the consumer, amount to an estimated net savings of around $14 billion over the next four years. This is a profound change.Many of these industry changes are strongly driven by public policy. In the last 3 years, important changes on health legislation improved by the Federal Commission for Protection against Health Risks (COFEPRIS),  the highest regulatory authority in the national health field. Changes include advertising and generics (regarding market access policy), among others. In an attempt to streamline its processes, COFEPRIS has also reached equivalence agreements with the FDA and Canada on devices, meaning that if a product is approved for use in the US or Canada it is also approved in Mexico. In a similar manner, COFEPRIS now sets the standard for other Latin American nations.

Regarding the “generics revolution” from October 2011 to October 2012, COFEPRIS released 25 patents of active substances, which could license up to 181 new generic products. These include Lipitor, for cholesterol; Viagra, for erectile dysfunction; Zyprexa, for schizophrenia; Singulair for asthma; Plavix, for thrombosis; Diovan for blood pressure, Lexapro for depression, and Taxotere, to treat certain cancers.

According to experts generic consumption will continue to grow with the release of patents and government’ support. This is why communication in healthcare must:

1. Be aligned with the environment’s needs and changes.
2. Have the ability to generate value on the drugs “access fight.”
3. Redefine the role of all stakeholders and audiences to accomplish successful and accurate strategic   communications.
4. Promote value-added strategies that address public health needs regarding aging populations and growth  in chronic diseases.
5. Increase digital communication, as well as, social media tactics among all audiences.

The post Pharma Communication in Mexico Changing According to Market Needs appeared first on GLOBALHealthPR.

Last Friday, I attended a meeting with the Neurological Device Panel of the FDA Medical Devices Advisory Committee. The panel came together to advise the FDA on the Premarket Approval Application of a new medical device to treat epilepsy. This device, the RNS System from NeuroPace, uses responsive neurostimulation to monitor and interrupt abnormal electrical activity in the brain before seizures occur. It is supposed to be a new treatment option for patients that had previously been treated with two or more anti-epileptic drugs without achieving seizure control and who are not suitable candidates for surgery.

The meeting showed how different views can reveal very diverse perspectives on a topic. The meeting started at 8am with the sponsor, NeuroPace, providing a well-prepared and well-timed presentation. Afterward, FDA representatives explained their view on the data – which was a rather long reading of facts and figures – and rounded out the presentation with important information regarding the product’s safety.

After the lunch break, the open public hearing started. I have to say, it was quite emotional and moving. Among other presenters, three patients described their lives before and after the implantation of the RNS System and how it changed everything; how they have been able to participate in everyday activities they weren’t able to before and how they can now take responsibility for themselves. Their stories showed how powerful individual and personal perspectives and real-life experiences are, leaving the audience visibly stunned at certain points.

A discussion about the effectiveness and safety of the RNS System followed in the afternoon before the experts were asked about their opinion of different data aspects and details. In the end, the expert panel voted in favor of the new device.

Attending the FDA Advisory Committee Meeting was a very interesting experience for me – as was my entire trip to Washington, D.C. This is a fascinating city and, as I have come to learn, it’s best explored on foot! I also have noticed people here are very active and running is very popular (and people run in shorts – even when it’s 0°C!). And of course, I have picked up some interesting insights into healthcare PR in the U.S. and helpful inspiration to bring back to Germany.

Last but not least, I’d like to thank the people here at Spectrum for welcoming me and taking time to share their experiences! I look forward to continuing and deepening this exchange in the future.

Auf Wiedersehen, Washington!

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