Reform Access to Information for Health Sector

The Canadian Open Government Initiative was announced on March 18, 2011. The project focuses on 3 main streams:

  • Open Data, which is about offering Government data in more useful and machine-readable formats to enable citizens, the private sector and non-government organizations to leverage it in innovative and value-added ways.
  • Open Information, which is about proactively releasing information, including on Government activities, to Canadians on an ongoing basis. It is about proactively making Government information easier to find and accessible for Canadians.
  • Open Dialogue, which is about giving Canadians a stronger say in Government policies and priorities, and expanding engagement through Web 2.0 technologies.

Since that time there have been some notable developments, including an Open Data Portal, publishing Access to Information Requests online, and updates to the Values and Ethics Code for public officials.

Yet the legislation governing information requests, the Access to Information Act, is outdated and has not been properly amended to reflect modern commercial practices. Members of the Advisory Panel on Open Government are already already calling for its reform, in advance of announcements expected this fall, and some are calling it a threat to Canadian democracy.

Private member bills have been introduced by both Pat Martin (defeated) and Justin Trudeau (just tabled this month) to introduce more transparency. But the current government does not appear to be willing to make the changes voluntarily,

Asked for Justice Minister Peter MacKay’s position on reforming the access law, spokeswoman Paloma Aguilar defended the government’s administration of the current law, saying the Conservatives had answered more requests than all previous administrations subject to the law combined.

One issue that has not been particularly emphasized in recent debates around the Act are the confidentiality provisions under s. 20, which provide trade secret and confidentiality provisions.

Subsection 20 (1)(b), which protects information which has been consistently treated as confidential by a third party, as well as subsection 20 (1)(b.1), covering information provided to the government in confidence, is considered redundant in light of the protections under subsection 20 (c), which encompasses information which could reasonably be expected to result in a financial loss or prejudice a competitive position.

The Office of the Information Commissioner of Canada has subsequently recommended repealing subsection 20 (1)(b) on several occasions, stating,

Government holds a vast array of information about private businesses information unrelated to government contracts. Ours is a highly regulated society. In many fields–agriculture, health, communications, environment, fisheries, native affairs, regional development–information from private sector firms figures prominently in government files. With government downsizing and privatization, more and more matters affecting the public interest are dealt with by the private sector. Government officials and private firms should not be able to agree among themselves to keep information secret. Yet, paragraph 20(1)(b) comes perilously close to giving authority for just such a cozy arrangement.

The Act also contains a public interest clause in subsection 20 (6) when dealing with public health and safety, or if the public interest outweighs any financial considerations. Despite this flexibility, the Commissioner suggested this provision is still being too narrow and recommended it be broadened beyond this narrow application.

The result of these restrictions do have significant impacts on our health and regulatory system. Whereas the US FDA announces topics under examination, has public timetables for hearings and public submissions, posts evidence considered with their competing interest, and provides complete rationale for their decisions, Health Canada refuses to provide any of this information by indicating that commercial interests exceed the need for disclosure.

This system has been criticized nearly 15 years ago by the chair of Health Canada’s Scientific Advisory Committee, Dr. Roberta Bondar, “for a level of confidentiality that is inconsistent with public expectation and contributes to public cynicism about the integrity of the process.”

Paul C. Hébert et al. state in the Canadian Medical Association Journal,

If the Harper government has truly changed its attitude and hopes to open government to Canadians, it should start by instructing Health Canada to make all regulatory submissions more open — by releasing the data it used, or mandating companies do so, by regularly holding open meetings, just as the FDA does, and publicly posting detailed rationales for its decisions.

Retweet information »

Comments

  1. In one of those strange “coincidences” of the universe, Health Canada announced the day after this was posted that they will be releasing more clinical trial data relating to off label use.

    From the Toronto Star:

    Health Canada will make public information it has kept secret regarding serious, sometimes fatal side-effects suspected to have been caused by unapproved “off-label” prescriptions.
    The announcement by the minister of health comes after an ongoing Star investigation exposed the federal regulator was scrubbing crucial information from public view.
    The information — which showed whether a drug involved in a side-effect case had been prescribed for an unapproved use — was removed from side-effect reports before Health Canada published those reports in its online public database.

    Of course the Access to Information Act still needs to be reformed independent of this, and there is still additional information like Case Report Forms which should be released (subject to confidentiality), but it is promising to see changes which will improve transparency and enhance patient safety.

Leave a Reply

(Your email address will not be published or distributed)