By Lisa Seachrist

Washington Editor

WASHINGTON - The Nov. 3 elections changed the complexion of Congress, but when the 106th Congress comes to town in January, it will be faced with many of the same issues debated in the 105th.

From a ban on cloning to medical privacy legislation to protecting the research and development (R&D) tax credit, the new Congress will be tackling a number of "leftover" measures vital to the biotechnology and pharmaceutical industries.

"We can see a number of issues on the horizon when Congress returns," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "Speaking from the biotech realm, I can certainly see another run at cloning legislation, as well as congressional interest in stem-cell developments."

This year started with a failed attempt by Senate Majority Leader Trent Lott (R-Miss.) to ramrod a ban on human cloning, without first moving the legislation through committee. A filibuster by Sen. Dianne Feinstein (D-Calif.) and the Democrats slowed the process. In the end, Lott fell far short of the necessary 60 votes to move the issue to the floor, as moderate Republicans crossed the aisle to oppose the effort.

Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers Association (PhRMA), agreed with Feldbaum's assessment that "cloning will remain an issue for this Congress."

Both BIO and PhRMA support a ban on human cloning as long as it protects legitimate research activities in the process, and the bill supported by Lott did not.

Industry Seeking Permanent R&D Credit

In addition to cloning, both organizations will be working to get the R&D tax credit extended. They hope it will be made a permanent fixture in the tax code.

As August approaches, Congress will be under a statutory deadline to deal with medical privacy. Under the Health Insurance Portability and Accountability Act of 1996, Congress must pass medical privacy protections, or the secretary of Health and Human Services will promulgate regulations to address the issue. Congress has repeatedly said that medical privacy is too important to be left to the regulators.

"We will definitely be seeing the medical privacy and genetic discrimination issues early in this Congress," Feldbaum said.

In addition, drug pricing may well be addressed early in the session, as the Medicare Study Commission issues its report in March, Trewhitt said.

Trewhitt and Feldbaum expect changes to the Hatch-Waxman Act, which lengthens patent term to compensate for delays at the FDA. Sen. Orrin Hatch (R-Utah) has signaled that he is eager to have another look at the legislation.

Last year, the industry made a major effort to restore the patent term lost as a result of the passage of the General Agreement on Tariffs and Trade (GATT). In the end, however, Lott declined to schedule floor time for the issue, and the Senate failed to pass the legislation.

"The No. 1 major issue we weren't able to kick across the goal line this session was patent reform" said Feldbaum.

Part of the problem was the fact that the patent reform issue is esoteric and difficult. In a Congress that was debating hot-button issues such as human cloning and presidential sexual misconduct, patent reform was placed on the back burner.

"I'm really hoping that Congress takes on patent reform rather than school uniforms," Feldbaum said.

Moderate Congress Looks Good To Biotech

With the exit of House Speaker Newt Gingrich (R-Ga.), the House will be led by the more moderate Rep. Bob Livingston (R-La.). In addition, the election brought more Democrats into the House and eliminated some of the more extreme right-wing members from both chambers.

"It certainly appears that it could be a more moderate Congress, the House in particular," said Feldbaum. "We can see it in statements made by Bob Livingston. But will representatives on the House side decide that Gingrich had been too moderate, and be driven to the right? I don't know."

On that issue, Feldbaum noted that one of the central determinants will be whether the Republicans decide they want to regain the more moderate, "center" position, or prefer to continue with a conservative social agenda - which voters have indicated they don't support.

"If a moderate Republican presidential candidate were to emerge, that would signal a move to the center, rather than a continuation of the divisiveness that plagued the 105th Congress," Feldbaum said.

Just how moderate this Congress might be in comparison to the highly partisan 105th Congress may be indicated in early December, when Sen. Arlen Specter (R-Pa.) holds hearings on embryonic stem cell research.

"This issue could really polarize," Feldbaum said. "We may see who we've elected in a whole new light." n