The Top 10 Regulatory Stories of 2012 (International Edition)

Posted 14 January 2013 | By

2012 was a momentous year for both the regulatory profession and Regulatory Focus. In our first year as an online-only publication, we covered a quickly changing landscape, dealing with topics that ranged through the quality of pharmaceutical products, the passage of new legislation, the safety of medical devices and the legal issues surrounding product regulation and marketing.

So what happened this year in global regulatory? We're glad you asked. The editors and staff of Regulatory Focus have sorted through the more than 1,600 articles we wrote this year to answer a difficult question: what were the top stories of the year?

Based on a number of factors-the impact of the story on the broader public, the staying power of the story, its impact on regulated industry, its precedence and its novelty-we've sorted, cut and condensed the year into a list of the 10 top stories.

Read on for our explanation of each story, including links to some of the most important aspects of each one.

[10] Kangaroos, Kiwis Coalesce

Australian and New Zealand regulators have for years been talking about a planned merger of their two regulatory agencies. Though the move isn't supposed to be finalized for another few years, 2012 marked a huge milestone for the initiative for one reason: The plan has moved past conceptualization and into its implementation stages.

In January 2012, Australia's Therapeutic Goods Administration (TGA) and New Zealand's MedSafe both laid out a proposed workflow detailing their plans for the new agency, called the Australia New Zealand Therapeutic products Agency (ANZTPA). In the subsequent months, they noted that the merger is on track and being guided by a new advisory body.

But those plans perhaps pale in comparison to something far simpler: The two agencies have now implemented joint regulatory actions together.

In their first action together, regulators implemented new transparency standards for a new joint database aimed at providing the public with easier access to adverse event information and provide assurances that medicines are safe. Ironically, the release caused something of a public panic after untrained media dug into the database and started questioning the safety of some vaccines based on unconfirmed reports.

Other activities, however, seems to have gone a bit more smoothly. In September 2012, TGA and MedSafe began to officially solicit input on a harmonized over-the-counter (OTC) medicines regulatory framework. That document would eventually become part of the broader overhaul, as explained in a framework released early in 2013.

With a combined population of 27 million people and a relatively large market for exports, Australia and New Zealand may be relatively small compared to a country like Pakistan (175 million people), which got its own regulatory authority for the first time this year. But ANZTPA could be groundbreaking precisely because of the broader questions it raises: could the merger of the two regulators-meant to cut costs and increase efficiency-be a model for other regional, small-market regulators in the future? Only time will tell.

[9] Over-the-Counter, Around the World

Global regulators seemed to all be thinking the same thing in 2012 in regard to one topic: over-the-counter (OTC) products.

The consensus among regulators was that the products, which are purchased directly by consumers without requiring a prescription, require new regulatory approaches.

In the US, the US Food and Drug Administration (FDA) is in the midst of looking at a sort of halfway point that would allow for easier prescribing of some relatively safe medications that aren't suitable for OTC use. That change would require new regulations, FDA said.

In the UK and Canada, meanwhile, regulators said they wanted to accelerate the process by which drugs undergo prescription-to-OTC switches. Canadian regulators said this was in recognition of the now-onerous process it takes to switch a medication, which can take close to two years. UK regulators agreed, saying they hoped to streamline the process to shave close to three months off the current one.

In other countries, such as Brazil, consumers will for the first time be allowed to purchase OTC drug products, while in Australia and New Zealand, companies will see changes meant to strengthen the evidence used to support OTC switches.

All in all, 2012 marked the start-not the finish-of a huge number of processes that will likely continue to play out well into 2013 and beyond.

[8] Shake, Rattle and Explode: Regulatory Systems in Crisis Situations

2012, like most years, saw its fair share of regular catastrophes leading to regulatory ones.

Case in point: A massive earthquake in the Italian province of Mirandola decimated much of that region's life sciences industry, including a large number of drug and device manufacturing facilities. The total damage was estimated at between two and five billion euros. Companies looking to get online would either have to get re-inspected by Italian and EMA regulators, or risk being shut down indefinitely. The interrupt was apparently too much for some companies, which simply shifted their manufacturing operations to other regions rather than rebuild.

In the Middle East, both Syria and Iran represent interesting case studies as well. Syria's civil war has left something of a wreckage of that country's regulatory system. The World Health Organization (WHO) noted that before the conflict, the country manufactured close to 90% of its own medicines. With the onset of conflict, however, both imports and raw materials have been in short supply, and increased bombings have left entire cities in ruin, further exacerbating problems.

Iran, meanwhile, has been hit with economic sanctions related to its alleged nuclear program. While the sanctions were crafted to exempt humanitarian-type aid, including medical supplies, they have still managed to cause huge shortages of many medicines and products.

And in Brazil, labor disputes caused much of the government, including the majority of the staff of local regulator Anvisa, to go on strike. At least 30% of staff remained at work during the strike, per a court order, but the agency's ability to function was reportedly severely diminished.

The take-away: if you deal with regulatory functions across the globe, it sure helps to have a contingency plan, because you never know when or where you're going to need it.

[7] Harmonized Out of Existence

2012 marked the 20th-and last-year of the Global Harmonization Task Force (GHTF). The consensus-based medical device standards organization was perhaps the most significant effort to date to bring together various regulatory authorities to create uniform definitions, standards and submission criteria for devices.

In November, GHTF Chair Kazunari Asanuma sent out the group's final goodbyes, reminding stakeholders that the organization had accomplished much in its 20 years of service. But the organization is unlikely to be missed too much; the International Medical Device Regulators Forum (IMDRF), the regulators-only (i.e. no industry stakeholders) successor to the GHTF, has announced that it will be maintaining and building upon GHTF's work.

[6] Heavy Metal Rocks Regulatory

2012 was a big year for medical device scandals, and two in particular. You'll read about the second one further on in this list, but the first one is in many ways just as important.

Metal-on-metal hips were meant to be a natural follow-on to similar devices already safely marketed to consumers for years. Over the course of the year, however, regulators around the world became increasingly concerned about the safety risks associated with the products, including whether the small metal shavings being generated through normal use could cause cancer, damage tissue or require costly-and dangerous-revision procedures to correct the faults.

In the US, most of the concerns had been known to regulators for some time, and most attention centered over whether the 510(k) substantial equivalence pathway, which allowed the product to come to market without first undergoing clinical testing, was adequate for implantable devices. Then, in June 2012, a panel of experts convened by FDA recommended against the use of the devices in patients, saying their rates of revision were too high. The devices, though, have not yet been recalled from the market-another point of controversy in the debate over the device's failings.

In the EU, the device's failing were-in combination with other scandals-enough to generate proposals for a medical device implant registry (immediately panned by industry). EU regulators, much like their US counterparts, also advised against the use of metal-on-metal implants, noting the high rates of required revisions relative to other hip replacement procedures.

In a year when supposedly low-risk implantable medical devices seemed to be failing at every turn, the role of metal-on-metal hips may have a lasting impact on the regulatory landscape, particularly if implant registries or new regulatory approaches to medical device approvals ever come to pass.


[5] The Watchers Get More Vigilant

2012 may well go down in EU circles as the year of pharmacovigilance. That's because new EU legislation on the subject finally came into force this year, and regulators and industry alike were scrambling to understand and implement its provisions.

The provisions are, in a word, numerous.  EMA started the year by releasing 'practical guidance' for industry on how best to implement the legislation, which is aimed at improving the safety and monitoring of medicines already approved for marketing in the EU.

Additional actions on the part of EMA included new user fees, numerousguideline modules, standard operating procedures, the closing of the Pharmacovigilance Working Party (PVWP), the founding of the Pharmacovigilance Risk Assessment Committee (PRAC), a new monitoring plan, a plethora of guidance documents, consultations on new pharmacovigilance features, and more.

Though many of these new guidelines and features are now finalized, the first few years promise to have some hiccups as companies get used to the new requirements and regulators deal with the increase in submitted data. 2013, in other words, is going to be a busy year for regulators and industry.


[4] China Gets Tough on Excipients

2012 was a big year for regulators with the Chinese Food and Drug Administration (SFDA) as well. The country has long been seen by some as being the source of counterfeit products, something that came to greater prominence in 2008 after counterfeit heparin products thought to have been manufactured in China were sold to consumers in the US.

In 2012, however, Chinese officials seemed primarily concerned about the excipients used in drug products, and in several instances cracked down on manufacturers it believed were substituting dangerous ingredients for their safer counterparts.

After conducting numerous raids on counterfeiters earlier in the year, SFDA unveiled new draft rules to require manufacturers to ensure excipient quality, a national campaign against counterfeit and inferior drugs, a new rule placing primary responsibility for excipient quality on pharmaceutical manufacturers, a new drug testing guidance aimed at reducing the number of counterfeit products and a new 'blacklist' regulators said would make it easier to punish counterfeiters.

Given the enormous size and scope of Chinese manufacturing operations-and new compulsory licensing changes aimed at increasing exports to developing countries-the changes could stand to benefit millions, if not billions, of consumers around the globe.

[3] EU Shakeups Abound

Some of the top regulatory spots in the EU are now occupied by different people than they were at the start of the year, and that could have big implications for the industry as it moves ahead into 2013 and 2014.

For starters: the top regulator on the Committee for Medicinal Products for Human Use (CHMP), Eric Abadie, resigned from the position in April 2012. Depending on who you ask, it was either fallout from his (alleged) role in overseeing the safety of the diabetes drug Mediator in France or simply a matter of money (chairman of CHMP is an unpaid position).

European health Commissioner John Dalli had a far less graceful exit from office than Abadie, resigning in the wake of a scandal in which his office was accused of trading favors with an entrepreneur in return for legislative support for a tobacco measure. Despite investigators not finding any evidence of wrong-doing, the case was referred to Maltese legal officials for further review and possible prosecution. Dalli resigned, he said, to focus on defending himself, leaving Malta's Tonio Borg to be appointed to the position in his stead.

Finally, 2012 marked the first full year in office for the new executive director of the European Medicines Agency, Guido Rasi. Rasi was appointed in November 2011 in the wake of the abrupt resignation of Thomas Lonngren, who has since been dogged by allegations of conflict of interest. Rasi has been hard at work trying to turn around the reputation of EMA, taking a number of steps to improve its transparency and be more accountable to stakeholders.

[2] Indian Regulators' Tough Year

India's drug regulatory bodies were steeped in controversy in 2012. From the onset, Indian regulators and companies came under fire after media investigations found that clinical trials conducted in the country may not be affording adequate protections to participants, either in the form of compensation for injuries suffered in the course of the trial or from potentially unsafe drug products.

As the year went on, a seemingly endless wave of bad news hit regulators, and in particular the Central Drugs Standard Control Organization (CDSCO). An April 2012 report indicated that the CDSCO was no longer exercising its authority to regulate the approval of drugs, while subsequent reports indicated that it had approved some drugs without the required clinical testing and had colluded with industry, leading to a legislative investigation into the regulator. The results of that investigation were far from kind, and recommended an audit and re-examination of many drugs previously approved by CDSCO.

While the bad new seemed to ease toward the end of the year, CDSCO is presumably hoping 2013 gets off to a better start than 2012.

[1] A French Company's Defects Lead to Global Change

Earlier in this piece, we alluded to the fact that there were two big medical device implant scandals this year. The first pertained to metal-on-metal hips. The second, this story, pertains to implants both in the literal and colloquial sense of the word.

Reports emerged in the waning days of 2011 that Poly Implant Prothese (PIP), a French breast implant manufacturer, had for years manufactured a defective product using unapproved industrial silicone in its products.

In the ensuing uproar, EU regulators-and in particular those of then-French regulator Afssaps-scrambled to assess the impact of the defective implants on patients' health. Experts eventually determined that the implants were more prone to rupture, and patients around the globe were advised to have them removed.

The oversight infuriated patients and legislators alike, contributing to the dissolution and re-launch of Afssaps as the ANSM, the arrest of PIP's top executives, and calls to overhaul the entire way medical devices are regulated in the EU and for stricter oversight of the notified bodies that now do much of the regulatory heavy lifting in the EU.

EU regulators, much like their Indian drug regulatory counterparts, are likely hoping that 2013 gets off to a less hectic and scandalous start than the year prior. We can only hope so as well.

Agree or disagree with any of our assessments? Did we entirely miss a story that you believe deserved attention? Let us know on Twitter at us at @RAPSorg or @AlecGaffney. If you missed our 'US Top 25 Regulatory Stories of 2012' countdown, it may be found here.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles